Determination — pharmaceutical benefits
(PB 89 of 2007)
as amended
made under sections 85, 85A and 88 of the
National Health Act 1953
This compilation was prepared on 31 July 2008
taking into account amendments up to PB 70 of 2008
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra
Determinations — pharmaceutical benefits (PB 89 of 2007)
Commencement [see Note 1]
1. This instrument commences on 1 December 2007.
Repeal
2. Instrument number PB 49 of 2007 is repealed.
Definitions
3. In this instrument:
"Act" means the National Health Act 1953;
"base‑priced drug" means —
(a) in relation to ranitidine (tablet, effervescent, 150 mg (as hydrochloride) or syrup 150 mg (as hydrochloride) per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine (tablet 150 mg (as hydrochloride) or tablet 300 mg (as hydrochloride)); or
(b) in relation to lercanidipine or nifedipine (tablet 20 mg (controlled release)): amlodipine, felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release));
"CFC" means chlorofluorocarbon;
"CFU" means colony forming unit;
"electronic communication" has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;
"g" means gram;
"I.M." means intramuscular;
"I.U." means international unit;
"I.V." means intravenous;
"kg" means kilogram;
"L" means litre;
"m" means metre;
"Medicare Australia CEO" means the Chief Executive Officer of Medicare Australia;
"mg" means milligram;
"mL" means millilitre;
"mm" means millimetre;
"mmol" means millimole;
"palliative care patient", in relation to a purpose specified in Part 2 of the Schedule 2, means a patient with an active, progressive, far‑advanced disease, and for whom the prognosis is limited and the focus of care is the quality of life;
"PBS" means Pharmaceutical Benefits Scheme;
"Regulations" means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
Form
4. For the purposes of subsection 85(3) of the Act, where the strength, type of unit, size of unit or other particulars of form are mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 in relation to a listed drug, these particulars are the form or forms of that listed drug.
4A. For the purposes of subsection 85(3) of the Act, a form mentioned in Schedule 4 is a form of a medicinal preparation composed of one or more drugs or medicinal preparations, including a medicinal preparation containing an additive.
Manner of administration
5. For the purposes of subsection 85(5) of the Act, the manner of administration mentioned under the column headed "Manner of administration" in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a form of a listed drug is the manner of administration for that form of the listed drug.
Brand
5A. For the purposes of subsection 85(6) of the Act, a brand mentioned in Schedule 1 or, if not mentioned in Schedule 1, in Schedule 2 for a listed drug in a pharmaceutical item, in a form and with a manner of administration mentioned for the listed drug, is the brand of that pharmaceutical item.
Participating dental practitioners
5B. For the purposes of subsection 88(1A) of the Act, the pharmaceutical benefits mentioned in Schedule 3 are the pharmaceutical benefits for the supply of which a participating dental practitioner is authorised to write a prescription.
Prescription
6. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 1 or of Schedule 2 for a pharmaceutical item or pharmaceutical benefit are the maximum quantities and number of repeats that a medical practitioner may prescribe or direct on one occasion for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.
7. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats specified in Part 2 of Schedule 3 for a pharmaceutical benefit or pharmaceutical item are the maximum quantities and number of repeats that a participating dental practitioner may prescribe or direct on one occasion but only for the purposes mentioned for the pharmaceutical item or pharmaceutical benefit and no other purposes.
8. For the purposes of subsection 85A(2) of the Act, the manner of administration, if any, mentioned for a pharmaceutical benefit in:
(a) Schedule 1 or, if not mentioned in Schedule1, in Schedule 2, is the only manner in which a medical practitioner may, in a prescription, direct the pharmaceutical benefit to be administered; or
(b) Schedule 3, is the only manner in which a participating dental practitioner may, in a prescription, direct the pharmaceutical benefit to be administered.
9. For the purposes of subsection 85A(2) of the Act, the maximum quantity or number of units of a pharmaceutical item or pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion is:
(a) where a pharmaceutical item or pharmaceutical benefit is mentioned —
(i) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(ii) in Part 2 of Schedule 1 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(iii) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(iv) in Part 2 of Schedule 2 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(v) in Part 1 of Schedule 3 — the quantity or number, if any, specified in that Part in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(vi) in Part 2 Schedule 3 and the pharmaceutical item or pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical item or pharmaceutical benefit; or
(b) in any other case — the quantity or number, if any, specified in the column headed “Maximum quantity” in Schedule 4 for the form of the pharmaceutical benefit.
10. For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit may, in one prescription, be directed by a medical practitioner to be repeated is:
(a) where the pharmaceutical benefit is mentioned —
(i) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(ii) in Part 2 of Schedule 1 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(iii) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(iv) in Part 2 of Schedule 2 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(b) in any other case — the number, if any, specified in the column headed “Maximum number of repeats” in Schedule 4 for the form of the pharmaceutical benefit.
11. The following purposes are specified in relation to each pharmaceutical benefit mentioned in Part 2 of Schedule 1 or 2:
(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes”
(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose;
(d) where it is specified in the column headed “Purposes” that compliance with authority procedures set out in subparagraph 11(d) is required — that a medical practitioner has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:
(i) by delivering or posting to the Medicare Australia CEO the prescription prepared and signed by the medical practitioner:
(A) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or
(B) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or
(C) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
(D) by a method approved in writing by the Secretary; or
(ii) by submitting the prescription by giving the Medicare Australia CEO by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i); or
(iii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO; or
(iv) by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i).
11A. For the purposes of subparagraph 11(d)(i), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.
12. Subject to paragraph 12B, the authorisation of a prescription submitted under subparagraph 11(d) may be made:
(a) if the prescription was submitted in accordance with subsubparagraph 11(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:
(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
(ii) in any other case:
(A) by returning it to the medical practitioner; or
(B) by sending it to the person in respect of whom it was prepared; or
(b) if the prescription was submitted in accordance with subsubparagraph 11(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or
(c) if the prescription was submitted in accordance with subsubparagraph 11(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner.
12A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(b) or (c):
(a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; and
(b) the medical practitioner must:
(i) mark that number on the prescription; and
(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
12B. Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.
12BA. If a medical practitioner has written on a prescription, that has been prepared and signed in accordance with subsubparagraph 11(d)(i), the streamlined authority code mentioned in Part 2 of Schedule 1 for a pharmaceutical benefit and purpose:
(a) subparagraph 11(d) is taken to have been complied with; and
(b) the Medicare Australia CEO is taken to have authorised the prescription.
12BB. Paragraph 12BA applies to a prescription only if there is a streamlined authority code for the pharmaceutical benefit and purpose in Part 2 of Schedule 1.
12C. Where a prescription is authorised, or deemed to be authorised, in accordance with paragraph 12, and an authorisation is also granted in accordance with subregulation 13(5) of the Regulations increasing the maximum quantity or number of units of the pharmaceutical benefit that may, in the prescription, be directed to be supplied on any one occasion, or the maximum number of occasions on which the supply of the pharmaceutical benefit may, in the prescription, be directed to be repeated, the authorisation in accordance with paragraph 12 is taken to be for the prescription of the increased quantity, number, or occasions, as the case may be.
13. The following purposes are specified in relation to a pharmaceutical benefit mentioned in Part 2 of Schedule 3:
(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;
(b) where a disease or condition is specified in the column headed “Purposes” —
(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or
(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;
(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose.
Abciximab | I.V. injection 10 mg in 5 mL vial | Injection | 3 | .. | ReoPro |
Acamprosate | Tablet (enteric coated) containing acamprosate calcium 333 mg | Oral | 180 | 1 | Campral |
Acarbose | Tablet 50 mg | Oral | 90 | 5 | Glucobay 50 |
| Tablet 100 mg | Oral | 90 | 5 | Glucobay 100 |
Acetazolamide | Tablet 250 mg | Oral | 100 | 3 | Diamox |
Acetylcysteine | Inhalation solution 200 mg (as sodium) per mL, 5 mL | Inhalation | 30 | 3 | Mucomyst |
Aciclovir | Tablet 200 mg | Oral | 50 | .. | Acihexal |
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| Acyclo‑V 200 |
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| GenRx Aciclovir |
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| Lovir |
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| Zovirax 200 mg |
| Tablet 800 mg | Oral | 35 | .. | Aciclovir 800 |
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| Acihexal |
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| Acyclo‑V 800 |
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| GenRx Aciclovir |
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| Lovir |
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| Zovirax 800 mg |
| Eye ointment 30 mg per g, 4.5 g | Application to the eye | 1 | .. | Zovirax |
Acitretin | Capsule 10 mg | Oral | 100 | 2 | Neotigason |
| Capsule 25 mg | Oral | 100 | 2 | Neotigason |
Adalimumab | Injection 40 mg in 0.8 mL pre‑filled syringe | Injection | 2 | 3 | Humira |
| Injection 40 mg in 0.8 mL pre‑filled pen | Injection | 2 | 3 | Humira |
Adrenaline | Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000) | Injection | 5 | 1 | AstraZeneca Pty Ltd |
| I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector | Injection | 1 | .. | EpiPen Jr. |
| I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector | Injection | 1 | .. | EpiPen |
Albendazole | Tablet 200 mg | Oral | 6 | .. | Zentel |
| Tablet 400 mg | Oral | 60 | 2 | Eskazole |
Alendronic Acid | Tablet 70 mg (as alendronate sodium) | Oral | 4 | 5 | Adronat |
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| Alendrobell 70mg |
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| Alendro Once Weekly |
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| APO‑Alendronate |
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| Chem mart Alendronate70mg |
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| Fosamax Once Weekly |
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| Ossmax 70mg |
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| Terry White Chemists Alendronate70mg |
| Tablet 40 mg (as alendronate sodium) | Oral | 30 | 5 | Fosamax 40 mg |
Alendronic Acid with Colecalciferol | Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol | Oral | 4 | 5 | Fosamax Plus |
Alginic acid with calcium carbonate and sodium bicarbonate | Oral liquid containing alginic acid as sodium alginate 1 g, calcium carbonate 320 mg and sodium bicarbonate 534 mg in 20 mL, 500 mL | Oral | 2 | 5 | Gaviscon P |
Allopurinol | Tablet 100 mg | Oral | 200 | 2 | Allohexal |
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| Allosig |
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| Chem mart Allopurinol |
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| GenRx Allopurinol |
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| Progout 100 |
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| Terry White Chemists Allopurinol |
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| Zyloprim |
| Tablet 300 mg | Oral | 60 | 2 | Allohexal |
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| Allosig |
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| Chem mart Allopurinol |
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| GenRx Allopurinol |
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| Progout 300 |
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| Terry White Chemists Allopurinol |
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| Zyloprim |
Alprazolam | Tablet 250 micrograms | Oral | 50 | .. | Alprax 0.25 |
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| Kalma 0.25 |
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| Xanax |
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| Zamhexal 0.25mg |
| Tablet 500 micrograms | Oral | 50 | .. | Alprax 0.5 |
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| Kalma 0.5 |
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| Xanax |
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| Zamhexal 0.5mg |
| Tablet 1 mg | Oral | 50 | 2 | Alprax 1 |
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| Alprazolam‑DP |
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| Chem mart Alprazolam |
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| GenRx Alprazolam |
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| Kalma 1 |
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| Terry White Chemists Alprazolam |
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| Xanax |
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| Zamhexal 1.0mg |
| Tablet 2 mg | Oral | 50 | 2 | Alprax 2 |
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| Alprazolam‑DP |
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| Chem mart Alprazolam |
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| GenRx Alprazolam |
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| Kalma 2 |
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| Terry White Chemists Alprazolam |
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| Xanax Tri‑Score |
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| Zamhexal 2mg |
Aluminium Hydroxide with Magnesium Hydroxide | Tablet 200 mg‑200 mg | Oral | 200 | 5 | Mylanta P |
| Oral suspension 200 mg‑200 mg per 5 mL, 500 mL | Oral | 2 | 5 | Mylanta P |
Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide | Oral suspension 250 mg‑120 mg‑120 mg per 5 mL, 500 mL | Oral | 2 | 5 | Gastrogel |
Amantadine | Capsule containing amantadine hydrochloride 100 mg | Oral | 100 | 5 | Symmetrel 100 |
Amiloride | Tablet containing amiloride hydrochloride 5 mg | Oral | 100 | 1 | Kaluril |
Amino acid formula without methionine, threonine and valine and low in isoleucine | Oral powder 200 g (XMTVI Asadon) | Oral | 5 | 5 | XMTVI Asadon |
Amino acid formula without phenylalanine | Capsules 500 mg, 200 (Phlexy‑10) | Oral | 16 | 5 | Phlexy‑10 |
| Tablets 1 g, 75 (Phlexy‑10) | Oral | 24 | 5 | Phlexy‑10 |
| Bars 42 g, 20 (Phlexy‑10) | Oral | 10 | 5 | Phlexy‑10 |
| Sachets containing oral powder 20 g, 30 (Phlexy‑10 Drink Mix) | Oral | 7 | 5 | Phlexy‑10 Drink Mix |
| Oral powder 250 g (PK AID II) | Oral | 8 | 5 | PK AID II |
Amino acid formula without phenylalanine, and vitamins with minerals | Pack containing 60 sachets of phenylalanine‑free amino acid formula oral powder 17 g, and 60 tablets containing vitamins and minerals (add‑ins) | Oral | 3 | 5 | add‑ins |
Amino acid formula without phenylalanine, tyrosine and methionine | Oral powder 500 g (XPTM Tyrosidon) | Oral | 4 | 5 | XPTM Tyrosidon |
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine | Oral powder 400 g (XP Analog LCP) | Oral | 8 | 5 | XP Analog LCP |
Amino acid formula with vitamins and minerals without lysine and low in tryptophan | Oral powder 400 g (XLYS, LOW TRY Analog) | Oral | 8 | 5 | XLYS, LOW TRY Analog |
| Oral powder 500 g (XLYS, LOW TRY Maxamaid) | Oral | 8 | 5 | XLYS, LOW TRY Maxamaid |
Amino acid formula with vitamins and minerals without methionine | Oral powder 400 g (XMET Analog) | Oral | 8 | 5 | XMET Analog |
| Sachets containing oral powder 20 g, 30 (HCU gel) | Oral | 4 | 5 | HCU gel |
| Sachets containing oral powder 25 g, 30 (HCU express) | Oral | 4 | 5 | HCU express |
| Oral powder 500 g (XMET Maxamaid) | Oral | 8 | 5 | XMET Maxamaid |
| Oral powder 500 g (XMET Maxamum) | Oral | 8 | 5 | XMET Maxamum |
| Oral liquid 130 mL, 30 (HCU Cooler) | Oral | 4 | 5 | HCU Cooler |
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine | Oral powder 400 g (XMTVI Analog) | Oral | 8 | 5 | XMTVI Analog |
| Oral powder 500 g (XMTVI Maxamaid) | Oral | 8 | 5 | XMTVI Maxamaid |
| Oral powder 500 g (XMTVI Maxamum) | Oral | 8 | 5 | XMTVI Maxamum |
Amino acid formula with vitamins and minerals without phenylalanine | Sachets containing oral powder 20 g, 30 (PKU‑gel) | Oral | 4 | 5 | PKU‑gel |
| Sachets containing oral powder 25 g, 30 (PKU‑Express) | Oral | 4 | 5 | PKU‑Express |
| Sachets containing oral powder 27.8 g, 30 (Lophlex) | Oral | 3 | 5 | Lophlex |
| Sachets containing oral powder 29 g, 30 (Minaphlex) | Oral | 4 | 5 | Minaphlex |
| Sachets containing oral powder 50 g, 30 (XP Maxamum) | Oral | 3 | 5 | XP Maxamum |
| Oral powder 400 g (XP Analog) | Oral | 8 | 5 | XP Analog |
| Oral powder 325 g (Phenex‑2) | Oral | 10 | 5 | Phenex‑2 |
| Oral powder 400 g (Phenex‑2) | Oral | 8 | 5 | Phenex‑2 |
| Oral powder 500 g (XP Maxamaid) | Oral | 8 | 5 | XP Maxamaid |
| Oral powder 500 g (XP Maxamum) | Oral | 8 | 5 | XP Maxamum |
| Oral liquid 250 mL (Easiphen) | Oral | 90 | 5 | Easiphen |
| Oral liquid 87 mL, 30 (PKU Cooler 10) | Oral | 4 | 5 | PKU Cooler 10 |
| Oral liquid 125 mL, 30 (Lophlex LQ) | Oral | 3 | 5 | Lophlex LQ |
| Oral liquid 130 mL, 30 (PKU Cooler 15) | Oral | 4 | 5 | PKU Cooler 15 |
| Oral liquid 174 mL, 30 (PKU Cooler 20) | Oral | 4 | 5 | PKU Cooler 20 |
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine | Sachets containing oral powder 20 g, 30 (TYR gel) | Oral | 4 | 5 | TYR gel |
| Sachets containing oral powder 25 g, 30 (TYR Express) | Oral | 4 | 5 | TYR Express |
| Oral powder 400 g (XPhen, Tyr Analog) | Oral | 8 | 5 | XPhen, Tyr Analog |
| Oral powder 500 g (XPhen, Tyr Maxamaid) | Oral | 8 | 5 | XPhen, Tyr Maxamaid |
| Oral powder 500 g (XPhen, Tyr Maxamum) | Oral | 8 | 5 | XPhen, Tyr Maxamum |
| Oral liquid 130 mL, 30 (TYR Cooler) | Oral | 4 | 5 | TYR Cooler |
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine | Sachets containing oral powder 20 g, 30 (MSUD‑gel) | Oral | 4 | 5 | MSUD‑gel |
| Sachets containing oral powder 25 g, 30 (MSUD Express) | Oral | 4 | 5 | MSUD Express |
| Sachets containing oral powder 29 g, 30 (Mapleflex) | Oral | 4 | 5 | Mapleflex |
| Oral powder 350 g (Ketonex‑1) | Oral | 8 | 5 | Ketonex‑1 |
| Oral powder 400 g (MSUD Analog) | Oral | 8 | 5 | MSUD Analog |
| Oral powder 325 g (Ketonex‑2) | Oral | 10 | 5 | Ketonex‑2 |
| Oral powder 500 g (MSUD AID III) | Oral | 4 | 5 | MSUD AID III |
| Oral powder 500 g (MSUD Maxamaid) | Oral | 8 | 5 | MSUD Maxamaid |
| Oral powder 500 g (MSUD Maxamum) | Oral | 8 | 5 | MSUD Maxamum |
| Oral liquid 130 mL, 30 (MSUD Express Cooler) | Oral | 4 | 5 | MSUD Express Cooler |
Amino acids — synthetic, formula | Oral powder 400 g (EleCare) | Oral | 8 | 5 | EleCare |
| Oral powder 400 g (Neocate) | Oral | 8 | 5 | Neocate |
| Oral powder 400 g (Neocate Advance) | Oral | 8 | 5 | Neocate Advance |
| Oral powder 400 g (Neocate Advance Tropical Flavour) | Oral | 8 | 5 | Neocate Advance Tropical Flavour |
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Oral powder 400 g (Neocate LCP) | Oral | 8 | 5 | Neocate LCP |
Aminoglutethimide | Tablet 250 mg | Oral | 100 | 5 | Cytadren 250 |
Amiodarone | Tablet containing amiodarone hydrochloride 100 mg | Oral | 30 | 5 | Aratac 100 |
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| Cardinorm |
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| Cordarone X 100 |
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| GenRx Amiodarone |
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| Rithmik 100 |
| Tablet containing amiodarone hydrochloride 200 mg | Oral | 30 | 5 | Aratac 200 |
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| Cardinorm |
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| Chem mart Amiodarone |
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| Cordarone X 200 |
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| GenRx Amiodarone |
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| Rithmik 200 |
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| Terry White Chemists Amiodarone |
Amisulpride | Tablet 100 mg | Oral | 30 | 5 | Amisulpride 100 Winthrop Amisulpride Sandoz Solian 100 |
| Tablet 200 mg | Oral | 60 | 5 | Amisulpride 200 Winthrop Amisulpride Sandoz Solian 200 |
| Tablet 400 mg | Oral | 60 | 5 | Amisulpride 400 Winthrop Amisulpride Sandoz Solian 400 |
| Oral solution 100 mg per mL, 60 mL | Oral | 2 | 5 | Solian Solution |
Amitriptyline | Tablet containing amitriptyline hydrochloride 10 mg | Oral | 50 | 2 | Endep 10 |
| Tablet containing amitriptyline hydrochloride 25 mg | Oral | 50 | 2 | Endep 25 |
| Tablet containing amitriptyline hydrochloride 50 mg | Oral | 50 | 2 | Endep 50 |
Amlodipine | Tablet 5 mg (as besylate) | Oral | 30 | 5 | Amlodipine-GA Amlodipine generichealth Amlodipine Sandoz APO‑Amlodipine Chem mart Amlodipine Norvasc Perivasc Terry White Chemists Amlodipine |
| Tablet 5 mg (as maleate) | Oral | 30 | 5 | Amlo 5 |
| Tablet 10 mg (as besylate) | Oral | 30 | 5 | Amlodipine-GA Amlodipine generichealth Amlodipine Sandoz APO‑Amlodipine Chem mart Amlodipine Norvasc Perivasc Terry White Chemists Amlodipine |
| Tablet 10 mg (as maleate) | Oral | 30 | 5 | Amlo 10 |
Amlodipine with Atorvastatin | Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/10 |
| Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/20 |
| Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/40 |
| Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 5/80 |
| Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/10 |
| Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/20 |
| Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/40 |
| Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium) | Oral | 30 | 5 | Caduet 10/80 |
Amoxycillin | Tablet, chewable, 250 mg (as trihydrate) | Oral | 20 | 1 | Amoxil |
| Tablet 1 g (as trihydrate) | Oral | 14 | 1 | Amoxycillin Sandoz Maxamox |
| Capsule 250 mg (as trihydrate) | Oral | 20 | 1 | Alphamox 250 |
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| Terry White Chemists Amoxycillin |
| Capsule 500 mg (as trihydrate) | Oral | 20 | 1 | Alphamox 500 |
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| Terry White Chemists Amoxycillin |
| Sachet containing oral powder 3 g (as trihydrate) | Oral | 1 | .. | Amoxil |
| Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL | Oral | 1 | 1 | Amoxil |
| Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Alphamox 125 Amoxil Bgramin Chem mart Amoxycillin GenRx Amoxycillin Ranmoxy Terry White Chemists Amoxycillin |
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| Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Alphamox 250 Amohexal Amoxil Forte Bgramin Chem mart Amoxycillin Cilamox GenRx Amoxycillin Ranmoxy Terry White Chemists Amoxycillin |
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| Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Maxamox |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | 1 | Augmentin Duo Clamohexal Duo 500mg/125mg Clamoxyl Duo Clavulin Duo Curam 500/125 GA‑Amclav 500/125 Moxiclav Duo 500/125 |
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| Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | 1 | Augmentin Duo forte |
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| Chem mart Amoxycillin and Clavulanic Acid |
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| Clamohexal Duo Forte 875mg/125mg |
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| Clavulin Duo Forte |
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| Clavycillin 875/125 |
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| Curam 875/125 |
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| GA‑Amclav Forte 875/125 |
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| GenRx Amoxycillin and Clavulanic Acid |
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| Moxiclav Duo Forte 875/125 |
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| Terry White Chemists Amoxycillin and Clavulanic Acid |
| Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Oral | 1 | 1 | Augmentin Clamohexal 125mg/31.25mg/5mL Clamoxyl Clavulin |
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| Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Oral | 1 | 1 | Augmentin Duo 400 Clamohexal Duo 400mg/57mg/5mL Clamoxyl Duo 400 Clavulin Duo 400 |
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Amphotericin | Lozenge 10 mg | Oral | 20 | 1 | Fungilin |
| Powder for injection 50 mg | Injection | 1 | .. | Fungizone |
Ampicillin | Powder for injection 500 mg (as sodium) | Injection | 5 | 1 | Austrapen Ibimicyn |
| Powder for injection 1 g (as sodium) | Injection | 5 | 1 | Aspen Ampicyn Austrapen Ibimicyn |
Anakinra | Injection 100 mg in 0.67 mL single use pre‑filled syringe | Injection | 28 | 3 | Kineret |
Anastrozole | Tablet 1 mg | Oral | 30 | 5 | Arimidex |
Anecortave | Suspension for injection containing anecortave acetate 15 mg in 0.5 mL | Injection | 1 | .. | Retaane |
Apraclonidine | Eye drops 5 mg (as hydrochloride) per mL, 10 mL | Application to the eye | 1 | 2 | Iopidine 0.5% |
Aprepitant | Pack containing 1 capsule 125 mg and 2 capsules 80 mg | Oral | 1 | .. | Emend |
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Aripiprazole | Tablet 10 mg | Oral | 30 | 5 | Abilify |
| Tablet 15 mg | Oral | 30 | 5 | Abilify |
| Tablet 20 mg | Oral | 30 | 5 | Abilify |
| Tablet 30 mg | Oral | 30 | 5 | Abilify |
Aspirin | Tablet 100 mg | Oral | 112 | 1 | Astrix DBL Aspirin 100 mg |
| Tablet, dispersible, 300 mg | Oral | 96 | 1 | Solprin |
Atenolol | Tablet 50 mg | Oral | 30 | 5 | Anselol 50 mg |
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| Atehexal |
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| Chem mart Atenolol |
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| GenRx Atenolol |
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| Noten |
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| Tenormin |
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| Tensig |
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| Terry White Chemists Atenolol |
Atomoxetine | Capsule 10 mg (as hydrochloride) | Oral | 56 | 5 | Strattera |
| Capsule 18 mg (as hydrochloride) | Oral | 56 | 5 | Strattera |
| Capsule 25 mg (as hydrochloride) | Oral | 56 | 5 | Strattera |
| Capsule 40 mg (as hydrochloride) | Oral | 56 | 5 | Strattera |
| Capsule 60 mg (as hydrochloride) | Oral | 56 | 5 | Strattera |
Atorvastatin | Tablet 10 mg (as calcium) | Oral | 30 | 5 | Lipitor |
| Tablet 20 mg (as calcium) | Oral | 30 | 5 | Lipitor |
| Tablet 40 mg (as calcium) | Oral | 30 | 5 | Lipitor |
| Tablet 80 mg (as calcium) | Oral | 30 | 5 | Lipitor |
Atovaquone | Oral suspension 750 mg per 5 mL, 210 mL | Oral | 1 | .. | Wellvone |
Atropine | Injection containing atropine sulfate 600 micrograms in 1 mL | Injection | 10 | 1 | AstraZeneca Pty Ltd |
| Eye drops containing atropine sulfate 10 mg per mL, 15 mL | Application to the eye | 1 | 2 | Atropt |
Auranofin | Tablet 3 mg | Oral | 60 | 5 | Ridaura |
Aurothiomalate | Injection containing sodium aurothiomalate 10 mg | Injection | 10 | .. | Myocrisin |
| Injection containing sodium aurothiomalate 20 mg | Injection | 10 | 1 | Myocrisin |
| Injection containing sodium aurothiomalate 50 mg | Injection | 10 | 1 | Myocrisin |
Azathioprine | Tablet 25 mg | Oral | 100 | 2 | Azahexal Imuran |
| Tablet 50 mg | Oral | 100 | 2 | Azahexal |
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| Azamun |
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| Azapin |
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| GenRx Azathioprine |
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| Imuran |
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Azithromycin | Tablet 500 mg (as dihydrate) | Oral | 2 | .. | Zithromax |
| Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL | Oral | 1 | .. | Zithromax |
Baclofen | Tablet 10 mg | Oral | 100 | 5 | Baclo |
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| Chem mart Baclofen |
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| Clofen 10 |
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| GenRx Baclofen |
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| Lioresal 10 |
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| Stelax 10 |
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| Terry White Chemists Baclofen |
| Tablet 25 mg | Oral | 100 | 5 | Baclo |
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| Chem mart Baclofen |
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| Clofen 25 |
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| GenRx Baclofen |
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| Lioresal 25 |
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| Stelax 25 |
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| Terry White Chemists Baclofen |
Balsalazide | Capsule containing balsalazide sodium 750 mg | Oral | 180 | 5 | Colazide |
"BCG Immunotherapeutic" (Bacillus Calmette‑Guérin/ Connaught strain) | Single dose set comprising 1 vial powder for intravesical administration containing 6.6 to 19.2 x 108 CFU and 1 vial diluent 3 mL | Intravesical | 3 | 1 | ImmuCyst |
"BCG‑Tice" (Bacillus Calmette‑Guérin/ Tice strain) | Vial containing powder for intravesical administration approximately 5 x 108 CFU | Intravesical | 3 | 1 | OncoTICE |
Beclomethasone | Pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Qvar 50 |
| Pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Qvar 100 |
| Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Qvar 50 Autohaler |
| Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Qvar 100 Autohaler |
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre‑filled syringe | Injection | 10 | .. | Bicillin L‑A |
Benzathine Penicillin | Powder for injection 900 mg | Injection | 1 | .. | Pan Benzathine Benzylpenicillin |
Benzhexol | Tablet containing benzhexol hydrochloride 2 mg | Oral | 200 | 2 | Artane |
| Tablet containing benzhexol hydrochloride 5 mg | Oral | 200 | 1 | Artane |
Benztropine | Tablet containing benztropine mesylate 2 mg | Oral | 60 | 2 | Benztrop |
| Injection containing benztropine mesylate 2 mg in 2 mL | Injection | 5 | .. | Cogentin |
Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | Oral application | 1 | 1 | Difflam |
Benzylpenicillin | Powder for injection 600 mg (as sodium) | Injection | 10 | 1 | BenPen |
| Powder for injection 3 g (as sodium) | Injection | 10 | .. | BenPen |
Betamethasone | Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL | Injection | 5 | .. | Celestone Chronodose |
| Cream 500 micrograms (as dipropionate) per g, 15 g | Application | 1 | 1 | Diprosone Eleuphrat |
| Cream 200 micrograms (as valerate) per g, 100 g | Application | 2 | .. | Antroquoril |
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| Betnovate 1/5 |
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| Celestone‑M |
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| Cortival 1/5 |
| Ointment 500 micrograms (as dipropionate) per g, 15 g | Application | 1 | 1 | Diprosone Eleuphrat |
| Cream 500 micrograms (as valerate) per g, 15 g | Application | 1 | 1 | Betnovate 1/2 Cortival 1/2 |
| Ointment 200 micrograms (as valerate) per g, 100 g | Application | 2 | .. | Antroquoril Celestone‑M |
| Ointment 500 micrograms (as valerate) per g, 15 g | Application | 1 | 1 | Betnovate 1/2 Cortival 1/2 |
Betaxolol | Eye drops, suspension, 2.5 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 1 | 5 | Betoptic S |
| Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 1 | 5 | Betoptic BetoQuin |
Bethanechol | Tablet containing bethanechol hydrochloride 10 mg | Oral | 100 | 2 | Uro‑Carb |
Bicalutamide | Tablet 50 mg | Oral | 28 | 5 | Cosudex |
Bifonazole | Cream 10 mg per g, 15 g | Application | 2 | 3 | Mycospor |
Bimatoprost | Eye drops 300 micrograms per mL, 3 mL | Application to the eye | 1 | 5 | Lumigan |
Biperiden | Tablet containing biperiden hydrochloride 2 mg | Oral | 200 | 2 | Akineton |
Bisacodyl | Tablet 5 mg | Oral | 200 | 2 | Bisalax Lax‑Tab |
| Suppositories 10 mg, 10 | Rectal | 3 | 5 | Dulcolax Petrus Bisacodyl Suppositories |
| Suppositories 10 mg, 12 | Rectal | 3 | 4 | Fleet Laxative Suppositories Petrus Bisacodyl Suppositories |
| Enemas 10 mg in 5 mL, 25 | Rectal | 1 | 2 | Bisalax |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg | Oral | 28 | 5 | Bicor |
| Tablet containing bisoprolol fumarate 5 mg | Oral | 28 | 5 | Bicor |
| Tablet containing bisoprolol fumarate 10 mg | Oral | 28 | 5 | Bicor |
Bivalirudin | Powder for I.V. injection 250 mg (as trifluoroacetate) | Injection | 1 | .. | Angiomax |
Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Blenamax Blenoxane Hospira Pty Limited |
Bortezomib | Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) | Injection | 4 | 2 | Velcade |
Brimonidine | Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL | Application to the eye | 1 | 5 | Alphagan Enidin |
Brimonidine with Timolol | Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Combigan |
Brinzolamide | Eye drops 10 mg per mL, 5 mL | Application to the eye | 1 | 5 | Azopt BrinzoQuin |
Bromocriptine | Tablet 2.5 mg (as mesylate) | Oral | 30 | .. | Kripton 2.5 Parlodel |
| Capsule 5 mg (as mesylate) | Oral | 60 | 5 | Kripton 5 Parlodel |
| Capsule 10 mg (as mesylate) | Oral | 100 | 5 | Kripton 10 Parlodel |
Budesonide | Nebuliser suspension 500 micrograms in 2 mL single dose units, 30 | Inhalation | 1 | 5 | Pulmicort Respules |
| Nebuliser suspension 1 mg in 2 mL single dose units, 30 | Inhalation | 1 | 5 | Pulmicort Respules |
| Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Pulmicort Turbuhaler |
| Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Pulmicort Turbuhaler |
| Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Pulmicort Turbuhaler |
Budesonide with Eformoterol | Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | 1 | 5 | Symbicort Turbuhaler 100/6 |
| Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses | Inhalation by mouth | 1 | 5 | Symbicort Turbuhaler 200/6 |
| Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2 | Inhalation by mouth | 1 | 5 | Symbicort Turbuhaler 400/12 |
Buprenorphine | Transdermal patch 5 mg | Transdermal | 2 | .. | Norspan |
| Transdermal patch 10 mg | Transdermal | 2 | .. | Norspan |
| Transdermal patch 20 mg | Transdermal | 2 | .. | Norspan |
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) | Oral | 30 | .. | Bupropion‑RL |
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| Clorprax |
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| Prexaton |
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| Zyban |
Busulfan | Tablet 2 mg | Oral | 100 | .. | Myleran |
Cabergoline | Tablet 500 micrograms | Oral | 2 | .. | Dostinex |
| Tablet 1 mg | Oral | 30 | 5 | Cabaser |
| Tablet 2 mg | Oral | 30 | 5 | Cabaser |
| Tablet 4 mg | Oral | 30 | 5 | Cabaser |
Calcipotriol | Ointment 50 micrograms per g, 30 g | Application | 1 | 1 | Daivonex |
| Cream 50 micrograms (as monohydrate) per g, 30 g | Application | 1 | 1 | Daivonex |
| Scalp solution 50 micrograms (as monohydrate) per mL, | Application | 1 | 1 | Daivonex |
Calcitriol | Capsule 0.25 microgram | Oral | 100 | 3 | Calcitriol‑DP |
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| Citrihexal |
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| GenRx Calcitriol |
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| Kosteo |
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| Rocaltrol |
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| Sical |
Calcium | Tablet 250 mg (as citrate) | Oral | 240 | 1 | Citracal |
| Tablet, chewable, 500 mg (as carbonate) | Oral | 240 | 1 | Cal‑Sup |
Candesartan | Tablet containing candesartan cilexetil 4 mg | Oral | 30 | 5 | Atacand |
| Tablet containing candesartan cilexetil 8 mg | Oral | 30 | 5 | Atacand |
| Tablet containing candesartan cilexetil 16 mg | Oral | 30 | 5 | Atacand |
| Tablet containing candesartan cilexetil 32 mg | Oral | 30 | 5 | Atacand |
Candesartan with Hydrochlorothiazide | Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Atacand Plus 16/12.5 |
Capecitabine | Tablet 150 mg | Oral | 60 | 2 | Xeloda |
| Tablet 500 mg | Oral | 120 | 2 | Xeloda |
Captopril | Tablet 12.5 mg | Oral | 90 | 5 | Acenorm 12.5 mg |
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| Capoten |
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| Captohexal |
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| Chem mart Captopril |
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| GenRx Captopril |
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| Genepharm Pty Ltd |
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| Terry White Chemists Captopril |
| Tablet 25 mg | Oral | 90 | 5 | Acenorm 25 mg |
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| Capoten |
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| Captohexal |
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| Chem mart Captopril |
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| GenRx Captopril |
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| Genepharm Pty Ltd |
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| Terry White Chemists Captopril |
| Tablet 50 mg | Oral | 90 | 5 | Acenorm 50 mg |
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| Capoten |
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| Captohexal |
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| Chem mart Captopril |
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| GenRx Captopril |
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| Genepharm Pty Ltd |
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| Terry White Chemists Captopril |
| Oral solution 5 mg per mL, 95 mL | Oral | 1 | 5 | Capoten |
Carbamazepine | Tablet 100 mg | Oral | 200 | 2 | Carbamazepine Sandoz Tegretol 100 |
| Tablet 200 mg | Oral | 200 | 2 | Carbamazepine Sandoz Tegretol 200 Teril |
| Tablet 200 mg (controlled release) | Oral | 200 | 2 | Tegretol CR 200 |
| Tablet 400 mg (controlled release) | Oral | 200 | 2 | Tegretol CR 400 |
| Oral suspension 100 mg per 5 mL, 300 mL | Oral | 1 | 5 | Tegretol Liquid |
Carbimazole | Tablet 5 mg | Oral | 200 | 2 | Neo‑Mercazole |
Carbohydrate, fat, vitamins, minerals and trace elements | Oral powder 400 g (Pro‑Phree) | Oral | 8 | 5 | Pro‑Phree |
| Oral powder 400 g (Energivit) | Oral | 8 | 5 | Energivit |
Carbomer 974 | Ocular lubricating gel 3 mg per g, single dose units 0.5 g, 30 | Application to the eye | 3 | 5 | Poly Gel |
Carbomer 980 | Ocular lubricating gel 2 mg per g, 10 g | Application to the eye | 1 | 5 | GelTears PAA Viscotears Liquid Gel |
| Eye drops 2 mg per g, single dose units 0.6 mL, 30 | Application to the eye | 3 | 5 | Viscotears |
Carboplatin | Solution for I.V. injection 50 mg in 5 mL | Injection | 2 | .. | Carboplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd |
| Solution for I.V. injection 150 mg in 15 mL | Injection | 6 | .. | Carboplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd |
| Solution for I.V. injection 450 mg in 45 mL | Injection | 2 | .. | Carboplatin Ebewe Hospira Pty Limited Pfizer Australia Pty Ltd |
Carmellose | Eye drops containing carmellose sodium 5 mg per mL, 15 mL | Application to the eye | 1 | 5 | Refresh Tears Plus |
| Eye drops containing carmellose sodium 10 mg per mL, 15 mL | Application to the eye | 1 | 5 | Refresh Liquigel |
| Eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24 | Application to the eye | 4 | 5 | TheraTears |
| Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30 | Application to the eye | 3 | 5 | Cellufresh |
| Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 | Application to the eye | 3 | 5 | Celluvisc |
| Ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28 | Application to the eye | 3 | 5 | TheraTears |
Carmustine | Implants 7.7 mg, 8 | Implantation | 1 | .. | Gliadel |
Carvedilol | Tablet 3.125 mg | Oral | 30 | .. | Chem mart Carvedilol 3.125 mg |
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| Dilasig 3.125 |
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| Dilatrend 3.125 |
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| GenRx Carvedilol |
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| Kredex |
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| Terry White Chemists Carvedilol 3.125 mg |
| Tablet 6.25 mg | Oral | 60 | 5 | Chem mart Carvedilol 6.25 mg |
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| Dilasig 6.25 |
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| Dilatrend 6.25 |
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| GenRx Carvedilol |
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| Kredex |
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| Terry White Chemists Carvedilol 6.25 mg |
| Tablet 12.5 mg | Oral | 60 | 5 | Chem mart Carvedilol 12.5 mg |
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| Dilasig 12.5 |
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| Dilatrend 12.5 |
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| GenRx Carvedilol |
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| Kredex |
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| Terry White Chemists Carvedilol 12.5 mg |
| Tablet 25 mg | Oral | 60 | 5 | Chem mart Carvedilol 25 mg |
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| Dilasig 25 |
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| Dilatrend 25 |
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| GenRx Carvedilol |
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| Kredex |
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| Terry White Chemists Carvedilol 25 mg |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Oral | 10 | 1 | Ceclor CD |
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| Chem mart Cefaclor CD |
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| Douglas Cefaclor‑CD |
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| GenRx Cefaclor CD |
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| Karlor CD |
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| Keflor CD |
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| Ozcef |
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| Terry White Chemists Cefaclor CD |
| Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL | Oral | 1 | 1 | Aclor 125 Ceclor Cefaclor Sandoz Chem mart Cefaclor GenRx Cefaclor Keflor Ozcef Terry White Chemists Cefaclor |
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| Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL | Oral | 1 | 1 | Aclor 250 Ceclor Cefaclor Sandoz Chem mart Cefaclor GenRx Cefaclor Keflor Ozcef |
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| Terry White Chemists Cefaclor |
Cefepime | Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Maxipime |
| Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Maxipime |
Cefotaxime | Powder for injection 1 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited |
| Powder for injection 2 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited |
Ceftriaxone | Powder for injection 500 mg (as sodium) | Injection | 1 | .. | Ceftriaxone ICP |
| Powder for injection 1 g (as sodium) | Injection | 5 | .. | Ceftriaxone ICP |
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| Ceftriaxone Sandoz |
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| DBL Ceftriaxone |
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| Max Pharma Pty Ltd |
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| Rocephin |
| Powder for injection 2 g (as sodium) | Injection | 5 | .. | Ceftriaxone ICP |
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| Ceftriaxone Sandoz |
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| DBL Ceftriaxone |
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| Rocephin |
Cefuroxime | Tablet 250 mg (as axetil) | Oral | 14 | 1 | Zinnat |
Celecoxib | Capsule 100 mg | Oral | 60 | 3 | Celebrex |
| Capsule 200 mg | Oral | 30 | 3 | Celebrex |
Cephalexin | Capsule 250 mg (anhydrous) | Oral | 20 | 1 | Cephabell |
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| Cephalexin Max |
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| Chem mart Cephalexin |
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| Cilex |
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| GenRx Cephalexin |
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| Ialex |
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| Ibilex 250 |
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| Keflex |
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| Rancef |
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| Sporahexal |
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| Terry White Chemists Cephalexin |
| Capsule 500 mg (anhydrous) | Oral | 20 | 1 | Cephabell |
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| Cephalexin Max |
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| Chem mart Cephalexin |
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| Cilex |
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| GenRx Cephalexin |
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| Ialex |
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| Ibilex 500 |
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| Keflex |
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| Rancef |
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| Sporahexal |
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| Terry White Chemists Cephalexin |
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Oral | 1 | 1 | Cefalexin Sandoz |
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| Chem mart Cephalexin |
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| Cilex |
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| GenRx Cephalexin |
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| Ialex |
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| Ibilex 125 |
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| Keflex |
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| Terry White Chemists Cephalexin |
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Oral | 1 | 1 | Cefalexin Sandoz |
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| Chem mart Cephalexin |
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| Cilex |
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| GenRx Cephalexin |
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| Ialex |
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| Ibilex 250 |
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| Keflex |
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| Terry White Chemists Cephalexin |
Cephalothin | Powder for injection 1 g (as sodium) | Injection | 10 | 1 | Hospira Pty Limited Keflin Neutral |
Cephazolin | Powder for injection 500 mg (as sodium) | Injection | 10 | .. | Hospira Pty Limited |
| Powder for injection 1 g (as sodium) | Injection | 10 | .. | Cefazolin Sandoz Hospira Pty Limited Kefzol |
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | 1 | .. | Erbitux |
| Solution for I.V. infusion 100 mg in 50 mL | Injection | 1 | .. | Erbitux |
| Solution for I.V. infusion 500 mg in 100 mL | Injection | 1 | .. | Erbitux |
Chlorambucil | Tablet 2 mg | Oral | 100 | 2 | Leukeran |
Chloramphenicol | Ear drops (aqueous) 5 mg per mL, 5 mL | Application to the ear | 1 | 2 | Chloromycetin |
| Eye drops 5 mg per mL, 10 mL | Application to the eye | 1 | 2 | Chloromycetin Chlorsig |
| Eye ointment 10 mg per g, 4 g | Application to the eye | 1 | .. | Chloromycetin Chlorsig |
Chlorpromazine | Tablet containing chlorpromazine hydrochloride 10 mg | Oral | 100 | 5 | Largactil |
| Tablet containing chlorpromazine hydrochloride 25 mg | Oral | 100 | 5 | Largactil |
| Tablet containing chlorpromazine hydrochloride 100 mg | Oral | 100 | 5 | Largactil |
| Oral solution containing chlorpromazine hydrochloride 25 mg per 5 mL, 100 mL | Oral | 1 | 5 | Largactil |
| Injection containing chlorpromazine hydrochloride 50 mg in 2 mL | Injection | 10 | .. | Largactil |
Chlorthalidone | Tablet 25 mg | Oral | 100 | 1 | Hygroton 25 |
Cholestyramine | Sachets containing 4.7 g oral powder (equivalent to 4 g cholestyramine), 50 | Oral | 2 | 5 | Questran Lite |
| Sachets containing 9.4 g oral powder (equivalent to 8 g cholestyramine), 50 | Oral | 1 | 5 | Questran Lite |
Chorionic Gonadotrophin | Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL | Injection | 1 | 5 | Pregnyl |
| Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL | Injection | 1 | 5 | Pregnyl |
Ciclesonide | Pressurised inhalation 80 micrograms per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Alvesco 80 |
| Pressurised inhalation 160 micrograms per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Alvesco 160 |
Cimetidine | Tablet 200 mg | Oral | 120 | 5 | Magicul 200 Tagamet |
| Tablet 400 mg | Oral | 60 | 5 | GenRx Cimetidine Magicul 400 Tagamet |
| Tablet 800 mg | Oral | 30 | 5 | GenRx Cimetidine Magicul 800 |
Cinacalcet | Tablet 30 mg (as hydrochloride) | Oral | 28 | 5 | Sensipar |
| Tablet 60 mg (as hydrochloride) | Oral | 28 | 5 | Sensipar |
| Tablet 90 mg (as hydrochloride) | Oral | 28 | 5 | Sensipar |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | Oral | 14 | .. | C‑Flox 500 |
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| Cifran |
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| Ciprofloxacin 500 |
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| Ciprofloxacin‑BW |
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| Ciprol 500 |
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| Ciproxin 500 |
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| GenRx Ciprofloxacin |
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| Genepharm Pty Ltd |
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| Profloxin |
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| Proquin |
| Tablet 750 mg (as hydrochloride) | Oral | 14 | .. | C‑Flox 750 |
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| Cifran |
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| Ciprofloxacin 750 |
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| Ciprofloxacin‑BW |
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| Ciprol 750 |
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| Ciproxin 750 |
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| GenRx Ciprofloxacin |
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| Genepharm Pty Ltd |
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| Profloxin |
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| Proquin |
| Tablet 250 mg (as hydrochloride) | Oral | 2 | .. | Ciproxin 250 |
| Ear drops 3 mg (as hydrochloride) per mL, 5 mL | Application to the ear | 1 | 1 | Ciloxan |
| Eye drops 3 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 2 | .. | CiloQuin Ciloxan |
Cisplatin | I.V. injection 10 mg in 10 mL | Injection | 1 | .. | Pfizer Australia Pty Ltd |
| I.V. injection 50 mg in 50 mL | Injection | 1 | .. | Hospira Pty Limited Pfizer Australia Pty Ltd |
| I.V. injection 100 mg in 100 mL | Injection | 1 | .. | Cisplatin Ebewe Hospira Pty Limited |
Citalopram | Tablet 10 mg (as hydrobromide) | Oral | 28 | 5 | Celapram |
| Tablet 20 mg (as hydrobromide) | Oral | 28 | 5 | Celapram |
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| Celica |
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| Chem mart Citalopram |
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| Ciazil |
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| Cipramil |
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| Citalobell |
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| Citalopram 20 |
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| Citalopram Winthrop |
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| GenRx Citalopram |
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| Talam |
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| Talohexal |
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| Terry White Chemists Citalopram |
| Tablet 40 mg (as hydrobromide) | Oral | 28 | 5 | Celapram GenRx Citalopram Talohexal |
Cladribine | Injection 10 mg in 5 mL vial | Injection | 7 | .. | Litak |
| Solution for I.V. infusion 10 mg in 10 mL single use vial | Injection | 7 | .. | Leustatin |
Clarithromycin | Tablet 250 mg | Oral | 14 | 1 | Chem mart Clarithromycin |
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| Clarac |
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| Clarihexal |
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| Clarithro 250 |
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| GenRx Clarithromycin |
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| Kalixocin |
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| Klacid |
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| Terry White Chemists Clarithromycin |
Clindamycin | Capsule 150 mg (as hydrochloride) | Oral | 24 | .. | Cleocin Dalacin C |
Clodronic Acid | Capsule containing 400 mg sodium clodronate (as tetrahydrate) | Oral | 100 | 2 | Bonefos |
| Capsule containing 800 mg sodium clodronate (as tetrahydrate) | Oral | 60 | 2 | Bonefos 800 mg |
Clomiphene | Tablet containing clomiphene citrate 50 mg | Oral | 10 | 5 | Clomhexal |
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| Clomid |
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| Fermil |
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| GenRx Clomiphene |
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| Serophene |
Clomipramine | Tablet containing clomipramine hydrochloride 25 mg | Oral | 50 | 2 | Anafranil 25 |
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| Chem mart Clomipramine |
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| GenRx Clomipramine |
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| Placil |
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| Terry White Chemists Clomipramine |
Clonazepam | Tablet 500 micrograms | Oral | 200 | 2 | Paxam 0.5 Rivotril |
| Tablet 2 mg | Oral | 200 | 2 | Paxam 2 Rivotril |
| Oral liquid 2.5 mg per mL, 10 mL | Oral | 2 | .. | Rivotril |
| Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent) | Injection | 5 | .. | Rivotril |
Clonidine | Tablet containing clonidine hydrochloride 100 micrograms | Oral | 100 | 5 | Catapres 100 |
| Tablet containing clonidine hydrochloride 150 micrograms | Oral | 100 | 5 | Catapres |
Clopidogrel | Tablet 75 mg (as hydrogen sulfate) | Oral | 28 | 5 | Iscover Plavix |
Clotrimazole | Lotion 10 mg per mL, 20 mL | Application | 2 | 3 | Canesten |
Coal Tar ‑ Prepared | Gel 10 mg per g, 100 mL | Application | 1 | 2 | Exorex |
Codeine | Tablet containing codeine phosphate 30 mg | Oral | 20 | .. | Fawns and McAllan Proprietary Limited |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Oral | 20 | .. | Codalgin Forte |
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| Codapane Forte |
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| Comfarol Forte |
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| Dolaforte |
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| Panadeine Forte |
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| Prodeine Forte |
Colchicine | Tablet 500 micrograms | Oral | 100 | 2 | Colgout Lengout |
Colestipol | Oral powder, sachets containing colestipol hydrochloride 5 g, 120 | Oral | 1 | 5 | Colestid |
Copper Sulfate | Tablets, diagnostic compound, 36 | For external use | 2 | 3 | Clinitest |
Cortisone | Tablet containing cortisone acetate 5 mg | Oral | 50 | 4 | Cortate |
| Tablet containing cortisone acetate 25 mg | Oral | 60 | 4 | Cortate |
Cromoglycic Acid | Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic) | Inhalation by mouth | 100 | 5 | Intal Spincaps |
| Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses | Inhalation by mouth | 1 | 5 | Intal |
| Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Intal CFC‑Free |
| Pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Intal Forte CFC‑Free |
| Eye drops containing sodium cromoglycate 20 mg per mL, 10 mL | Application to the eye | 1 | 5 | Cromolux Opticrom |
Cyclophosphamide | Tablet 50 mg | Oral | 50 | 2 | Cycloblastin |
| Powder for injection 500 mg (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 2 | .. | Endoxan |
| Powder for injection 1 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 1 | .. | Endoxan |
| Powder for injection 2 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 1 | .. | Endoxan |
Cyclosporin | Capsule 10 mg | Oral | 120 | 3 | Neoral 10 |
| Capsule 25 mg | Oral | 60 | 3 | Cicloral Neoral 25 |
| Capsule 50 mg | Oral | 60 | 3 | Cicloral Neoral 50 |
| Capsule 100 mg | Oral | 60 | 3 | Cicloral Neoral 100 |
| Oral liquid 100 mg per mL, 50 mL | Oral | 2 | 3 | Neoral |
Cyproheptadine | Tablet containing cyproheptadine hydrochloride 4 mg (anhydrous) | Oral | 100 | 2 | Periactin |
Cyproterone | Tablet containing cyproterone acetate 50 mg | Oral | 20 | 5 | Androcur |
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| Cyprohexal |
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| Cyprone |
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| Cyprostat |
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| GenRx Cyproterone Acetate |
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| Procur |
| Tablet containing cyproterone acetate 100 mg | Oral | 50 | 5 | Androcur‑100 |
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| Cyprohexal |
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| Cyprostat‑100 |
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| GenRx Cyproterone Acetate |
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| Procur 100 |
Cystine with carbohydrate | Sachets of oral powder 4 g containing 500 mg cystine, 30 (Cystine Amino Acid Supplement) | Oral | 4 | 5 | Cystine Amino Acid Supplement |
Cytarabine | Injection 100 mg in 5 mL vial | Injection | 10 | 1 | Pfizer Australia Pty Ltd |
Dalteparin | Injection containing dalteparin sodium 2,500 I.U. (anti‑Xa) in 0.2 mL single dose pre‑filled syringe | Injection | 10 | 1 | Fragmin |
| Injection containing dalteparin sodium 5,000 I.U. (anti‑Xa) in 0.2 mL single dose pre‑filled syringe | Injection | 10 | 1 | Fragmin |
| Injection containing dalteparin sodium 7,500 I.U. (anti‑Xa) in 0.75 mL single dose pre‑filled syringe | Injection | 10 | 1 | Fragmin |
| Injection containing dalteparin sodium 10,000 I.U. (anti‑Xa) in 1 mL single dose pre‑filled syringe | Injection | 10 | 1 | Fragmin |
Danazol | Capsule 100 mg | Oral | 100 | 5 | Azol 100 |
| Capsule 200 mg | Oral | 100 | 5 | Azol 200 |
Dantrolene | Capsule containing dantrolene sodium 25 mg | Oral | 100 | 2 | Dantrium |
| Capsule containing dantrolene sodium 50 mg | Oral | 100 | 2 | Dantrium |
Dapsone | Tablet 25 mg | Oral | 100 | 1 | Link Medical Products Pty Ltd |
| Tablet 100 mg | Oral | 100 | 1 | Link Medical Products Pty Ltd |
Dasatinib | Tablet 20 mg | Oral | 60 | 2 | Sprycel |
| Tablet 50 mg | Oral | 60 | 2 | Sprycel |
| Tablet 70 mg | Oral | 60 | 2 | Sprycel |
Desmopressin | Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle | Nasal | 5 | 5 | Minirin |
| Tablet containing desmopressin acetate 200 micrograms | Oral | 30 | 5 | Minirin |
| Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL | Nasal | 1 | 5 | Minirin Nasal Spray |
Dexamethasone | Tablet 500 micrograms | Oral | 30 | 4 | Dexmethsone |
| Tablet 4 mg | Oral | 30 | 4 | Dexmethsone |
| Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL | Injection | 5 | .. | Hospira Pty Limited |
| Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL | Injection | 5 | 1 | Hospira Pty Limited |
| Eye drops 1 mg per mL, 5 mL | Application to the eye | 1 | 2 | Maxidex |
Dexamethasone with Framycetin and Gramicidin | Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL | Application to the ear | 1 | 2 | Otodex Sofradex |
Dexamphetamine | Tablet containing dexamphetamine sulfate 5 mg | Oral | 100 | 5 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Diazepam | Tablet 2 mg | Oral | 50 | .. | Antenex 2 |
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| Ducene |
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| Valium |
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| Valpam 2 |
| Tablet 5 mg | Oral | 50 | .. | Antenex 5 |
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| Diazepam‑DP |
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| Ducene |
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| Valium |
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| Valpam 5 |
| Injection 10 mg in 2 mL ampoule | Injection | 5 | .. | Hospira Pty Limited |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Oral | 100 | 3 | Chem mart Diclofenac |
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| Clonac 25 |
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| Diclohexal |
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| Dinac |
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| Fenac 25 |
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| GenRx Diclofenac |
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| Terry White Chemists Diclofenac |
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| Voltaren 25 |
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Oral | 50 | 3 | Chem mart Diclofenac |
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| Clonac 50 |
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| Diclohexal |
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| Dinac |
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| Fenac |
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| GenRx Diclofenac |
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| Terry White Chemists Diclofenac |
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| Voltaren 50 |
| Suppository containing diclofenac sodium 100 mg | Rectal | 40 | 3 | Voltaren 100 |
Dicloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Diclocil Dicloxsig Distaph 250 |
| Capsule 500 mg (as sodium) | Oral | 24 | .. | Diclocil Dicloxsig Distaph 500 |
| Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Diclocil |
| Powder for injection 1 g (as sodium) | Injection | 5 | 1 | Diclocil |
Digoxin | Tablet 62.5 micrograms | Oral | 200 | 1 | Lanoxin‑PG Sigmaxin‑PG |
| Tablet 250 micrograms | Oral | 100 | 1 | Lanoxin Sigmaxin |
| Paediatric oral solution 50 micrograms per mL, 60 mL | Oral | 2 | 3 | Lanoxin |
Dihydroergotamine | Injection containing dihydroergotamine mesylate 1 mg in 1 mL | Injection | 5 | .. | Dihydergot |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Oral | 90 | 5 | Cardizem |
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| Chem mart Diltiazem |
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| Coras |
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| Diltahexal |
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| Dilzem 60 mg |
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| GenRx Diltiazem |
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| Terry White Chemists Diltiazem |
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| Vasocardol |
| Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg | Oral | 30 | 5 | Cardizem CD |
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| Chem mart Diltiazem CD |
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| Diltahexal CD |
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| Dilzem CD |
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| GenRx Diltiazem CD |
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| Terry White Chemists Diltiazem CD |
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| Vasocardol CD |
| Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg | Oral | 30 | 5 | Cardizem CD |
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| Chem mart Diltiazem CD |
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| Diltahexal CD |
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| Dilzem CD |
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| GenRx Diltiazem CD |
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| Terry White Chemists Diltiazem CD |
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| Vasocardol CD |
| Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg | Oral | 30 | 5 | Cardizem CD Diltahexal CD Vasocardol CD |
Diphenoxylate with Atropine | Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms | Oral | 20 | .. | Lofenoxal Lomotil |
Diphtheria and tetanus vaccine, adsorbed, diluted for adult use | Injection 0.5 mL in pre‑filled syringe | Injection | 5 | .. | ADT Booster |
Dipivefrine | Eye drops containing dipivefrine hydrochloride 1 mg per mL, 10 mL | Application to the eye | 1 | 5 | Propine |
Dipyridamole | Capsule 200 mg (sustained release) | Oral | 60 | 5 | Persantin SR |
Dipyridamole with Aspirin | Capsule 200 mg (sustained release)‑25 mg | Oral | 60 | 5 | Asasantin SR |
Disopyramide | Capsule 100 mg | Oral | 100 | 5 | Rythmodan |
| Capsule 150 mg | Oral | 100 | 5 | Rythmodan |
Docetaxel | Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL and 1 single use vial solvent 1.5 mL | Injection | 2 | .. | Taxotere |
| Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL and 1 single use vial solvent 6 mL | Injection | 1 | .. | Taxotere |
Dolasetron | Tablet containing dolasetron mesylate 200 mg | Oral | 2 | .. | Anzemet |
| I.V. injection containing dolasetron mesylate 100 mg in 5 mL | Injection | 1 | .. | Anzemet |
Domperidone | Tablet 10 mg | Oral | 25 | .. | Motilium |
Donepezil | Tablet containing donepezil hydrochloride 5 mg | Oral | 28 | 5 | Aricept |
| Tablet containing donepezil hydrochloride 10 mg | Oral | 28 | 5 | Aricept |
Dorzolamide | Eye drops 20 mg (as hydrochloride) per mL, 5 mL | Application to the eye | 1 | 5 | Trusopt |
Dorzolamide with Timolol | Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Cosopt |
Dothiepin | Capsule containing dothiepin hydrochloride 25 mg | Oral | 50 | 2 | Dothep 25 Prothiaden |
| Tablet containing dothiepin hydrochloride 75 mg | Oral | 30 | 2 | Dothep 75 Prothiaden |
Doxepin | Tablet 50 mg (as hydrochloride) | Oral | 50 | 2 | Deptran 50 |
| Capsule 10 mg (as hydrochloride) | Oral | 50 | 2 | Deptran 10 Sinequan |
| Capsule 25 mg (as hydrochloride) | Oral | 50 | 2 | Deptran 25 Sinequan |
Doxorubicin | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial | Injection/intravesical | 4 | .. | Adriamycin Solution Doxorubicin Ebewe Hospira Pty Limited |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial | Injection/intravesical | 4 | .. | Adriamycin Solution |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial | Injection/intravesical | 3 | .. | Adriamycin Solution Doxorubicin Ebewe Hospira Pty Limited |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial | Injection/intravesical | 1 | .. | Doxorubicin Ebewe |
| Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial | Injection/intravesical | 1 | .. | Adriamycin Doxorubicin Ebewe |
Doxorubicin ‑ Pegylated Liposomal | Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL | Injection | 1 | .. | Caelyx |
| Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL | Injection | 1 | .. | Caelyx |
Doxycycline | Tablet 100 mg (as monohydrate) | Oral | 7 | 1 | Chem mart Doxycycline |
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| Doxyhexal |
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| GenRx Doxycycline |
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| Terry White Chemists Doxycycline |
| Tablet 100 mg (as hydrochloride) | Oral | 7 | 1 | Doxsig |
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| Doxy‑100 |
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| Doxylin 100 |
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| Vibramycin |
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) | Oral | 7 | 1 | DBL Doxycycline Doryx |
| Tablet 50 mg (as monohydrate) | Oral | 25 | 5 | Chem mart Doxycycline |
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| Doxyhexal |
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| Frakas |
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| GenRx Doxycycline |
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| Terry White Chemists Doxycycline |
| Tablet 50 mg (as hydrochloride) | Oral | 25 | 5 | Doxy‑50 Doxylin 50 Vibra‑Tabs |
| Capsule 50 mg (as hydrochloride) (containing enteric coated pellets) | Oral | 25 | 5 | DBL Doxycycline Doryx |
Drotrecogin Alfa (activated) | Powder for I.V. infusion 5 mg | Injection | 1 | .. | Xigris |
Duloxetine | Capsule 30 mg (as hydrochloride) | Oral | 28 | .. | Cymbalta |
| Capsule 60 mg (as hydrochloride) | Oral | 28 | 5 | Cymbalta |
Dydrogesterone | Tablet 10 mg | Oral | 28 | 2 | Duphaston |
Efalizumab | Injection set containing 4 vials powder for injection 125 mg and 4 pre‑filled syringes diluent 1.3 mL | Injection | 1 | 3 | Raptiva |
Eformoterol | Capsule containing powder for oral inhalation containing eformoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer) | Inhalation by mouth | 60 | 5 | Foradile |
| Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 6 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Oxis Turbuhaler |
| Powder for oral inhalation in breath actuated device containing eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Oxis Turbuhaler |
Electrolyte Replacement, Oral | Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 | Oral | 1 | .. | Chem mart Oral Rehydration Salts |
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| O.R.S. |
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| Repalyte New Formulation |
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| restore O.R.S. |
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| Terry White Chemists Oral Rehydration Salts |
Electrolyte Replacement, Solution | Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium gluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per L, 1 L | Injection | 2 | 1 | Plasma‑Lyte 148 |
Enalapril | Tablet containing enalapril maleate 5 mg | Oral | 30 | 5 | Alphapril |
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| Auspril |
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| Chem mart Enalapril |
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| Enahexal |
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| Enalabell |
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| Enalapril‑DP 5mg |
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| Enalapril Winthrop |
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| GenRx Enalapril |
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| Renitec M |
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| Terry White Chemists Enalapril |
| Tablet containing enalapril maleate 10 mg | Oral | 30 | 5 | Alphapril |
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| Amprace 10 |
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| Auspril |
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| Chem mart Enalapril |
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| Enahexal |
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| Enalabell |
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| Enalapril‑DP 10mg |
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| Enalapril Winthrop |
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| GenRx Enalapril |
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| Renitec |
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| Terry White Chemists Enalapril |
| Tablet containing enalapril maleate 20 mg | Oral | 30 | 5 | Alphapril |
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| Amprace 20 |
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| Auspril |
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| Chem mart Enalapril |
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| Enahexal |
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| Enalabell |
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| Enalapril‑DP 20mg |
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| Enalapril Winthrop |
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| GenRx Enalapril |
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| Renitec 20 |
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| Terry White Chemists Enalapril |
Enalapril with Hydrochlorothiazide | Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg | Oral | 30 | 5 | Enalapril/HCT Sandoz Renitec Plus 20/6 |
Enoxaparin | Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti‑Xa) in 0.2 mL pre‑filled syringe | Injection | 10 | 1 | Clexane |
| Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti‑Xa) in 0.4 mL pre‑filled syringe | Injection | 10 | 1 | Clexane |
| Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti‑Xa) in 0.6 mL pre‑filled syringe | Injection | 10 | 1 | Clexane |
| Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti‑Xa) in 0.8 mL pre‑filled syringe | Injection | 10 | 1 | Clexane |
| Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti‑Xa) in 1 mL pre‑filled syringe | Injection | 10 | 1 | Clexane |
Entacapone | Tablet 200 mg | Oral | 200 | 4 | Comtan |
Epirubicin | Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL | Injection/intravesical | 4 | .. | Epirubicin Ebewe Pharmorubicin Solution |
| Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL | Injection/intravesical | 4 | .. | Pharmorubicin Solution |
| Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL | Injection/intravesical | 4 | .. | Epirubicin Ebewe Hospira Pty Limited Pharmorubicin Solution |
| Powder for injection containing epirubicin hydrochloride 50 mg | Injection/intravesical | 4 | .. | Hospira Pty Limited |
| Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL | Injection/intravesical | 2 | .. | Epirubicin Ebewe Hospira Pty Limited |
| Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL | Injection/intravesical | 1 | .. | Epirubicin Ebewe |
Eplerenone | Tablet 25 mg | Oral | 30 | 5 | Inspra |
| Tablet 50 mg | Oral | 30 | 5 | Inspra |
Eprosartan | Tablet 400 mg (as mesylate) | Oral | 56 | 5 | Teveten |
| Tablet 600 mg (as mesylate) | Oral | 28 | 5 | Teveten |
Eprosartan with Hydrochlorothiazide | Tablet 600 mg eprosartan (as mesylate) with 12.5 mg hydrochlorothiazide | Oral | 28 | 5 | Teveten Plus 600/12.5 |
Eptifibatide | Solution for I.V. injection 20 mg (as acetate) in 10 mL | Injection | 2 | .. | Integrilin |
| Solution for I.V. infusion 75 mg (as acetate) in 100 mL | Injection | 3 | .. | Integrilin |
Erythromycin | Tablet 400 mg (as ethyl succinate) | Oral | 25 | 1 | E.E.S. 400 Filmtab E‑Mycin |
| Capsule 250 mg (containing enteric coated pellets) | Oral | 25 | 1 | DBL Erythromycin Eryc |
| Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | 1 | E.E.S. 200 E‑Mycin 200 |
| Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | 1 | E.E.S. Granules E‑Mycin 400 |
| Powder for I.V. infusion 1 g (as lactobionate) | Injection | 5 | .. | Erythrocin‑I.V. |
Escitalopram | Tablet 10 mg (as oxalate) | Oral | 28 | 5 | Esipram Lexapro |
| Tablet 20 mg (as oxalate) | Oral | 28 | 5 | Esipram Lexapro |
| Oral solution 10 mg (as oxalate) per mL, 28 mL | Oral | 1 | 5 | Lexapro |
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) | Oral | 30 | 1 | Nexium |
| Tablet (enteric coated) 40 mg (as magnesium trihydrate) | Oral | 30 | 1 | Nexium |
Esomeprazole and Clarithromycin and Amoxycillin | Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Oral | 1 | .. | Nexium Hp7 |
Essential amino acids formula with minerals and vitamin C | Oral powder 200 g (Dialamine) | Oral | 10 | 5 | Dialamine |
| Oral powder 400 g (Dialamine) | Oral | 5 | 5 | Dialamine |
Etanercept | Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL | Injection | 2 | 2 | Enbrel |
| Injection set containing 4 vials powder for injection 50 mg and 4 pre‑filled syringes solvent 1 mL | Injection | 1 | 2 | Enbrel |
| Injections 50 mg in 1 mL single use pre‑filled syringes, 4 | Injection | 1 | 2 | Enbrel |
Ethacrynic Acid | Tablet 25 mg | Oral | 200 | 1 | Edecrin |
Ethosuximide | Capsule 250 mg | Oral | 200 | 2 | Zarontin |
| Oral solution 250 mg per 5 mL, 200 mL | Oral | 1 | 5 | Zarontin |
Etidronic Acid | Tablet containing disodium etidronate 200 mg | Oral | 60 | 5 | Didronel |
Etidronic Acid and Calcium | Pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium 500 mg (as carbonate) | Oral | 1 | 1 | Didrocal |
Etonogestrel | Subcutaneous implant 68 mg | Implantation | 1 | .. | Implanon |
Etoposide | Capsule 50 mg | Oral | 20 | .. | Vepesid |
| Capsule 100 mg | Oral | 10 | .. | Vepesid |
| Solution for I.V. infusion 100 mg in 5 mL vial | Injection | 5 | .. | Etoposide Ebewe Hospira Pty Limited |
| Powder for I.V. infusion containing etoposide phosphate 113.6 mg | Injection | 5 | .. | Etopophos |
| Powder for I.V. infusion containing etoposide phosphate 1.136 g | Injection | 1 | .. | Etopophos |
Everolimus | Tablet 0.25 mg | Oral | 60 | 3 | Certican |
| Tablet 0.5 mg | Oral | 60 | 3 | Certican |
| Tablet 0.75 mg | Oral | 120 | 3 | Certican |
Exemestane | Tablet 25 mg | Oral | 30 | 5 | Aromasin |
Ezetimibe | Tablet 10 mg | Oral | 30 | 5 | Ezetrol |
Ezetimibe with Simvastatin | Tablet 10 mg‑40 mg | Oral | 30 | 5 | Vytorin |
| Tablet 10 mg‑80 mg | Oral | 30 | 5 | Vytorin |
Famciclovir | Tablet 125 mg | Oral | 40 | 1 | Famvir |
| Tablet 250 mg | Oral | 20 | 1 | Famvir |
| Tablet 500 mg | Oral | 30 | .. | Famvir |
Famotidine | Tablet 20 mg | Oral | 60 | 5 | Ausfam 20 |
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| Chem mart Famotidine |
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| Famohexal |
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| GenRx Famotidine |
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| Pamacid 20 |
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| Pepcidine M |
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| Pepzan |
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| Terry White Chemists Famotidine |
| Tablet 40 mg | Oral | 30 | 5 | Ausfam 40 |
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| Chem mart Famotidine |
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| Famohexal |
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| GenRx Famotidine |
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| Pamacid 40 |
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| Pepcidine |
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| Pepzan |
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| Terry White Chemists Famotidine |
Felodipine | Tablet 2.5 mg (extended release) | Oral | 30 | 5 | Felodur ER 2.5 mg Plendil ER |
| Tablet 5 mg (extended release) | Oral | 30 | 5 | Felodil XR 5 Felodur ER 5 mg Plendil ER |
| Tablet 10 mg (extended release) | Oral | 30 | 5 | Felodil XR 10 Felodur ER 10 mg Plendil ER |
Fenofibrate | Tablet 48 mg | Oral | 60 | 5 | Lipidil |
| Tablet 145 mg | Oral | 30 | 5 | Lipidil |
Fentanyl | Transdermal patch 2.1 mg | Transdermal | 5 | .. | Durogesic 12 |
| Transdermal patch 4.2 mg | Transdermal | 5 | .. | Durogesic 25 |
| Transdermal patch 8.4 mg | Transdermal | 5 | .. | Durogesic 50 |
| Transdermal patch 12.6 mg | Transdermal | 5 | .. | Durogesic 75 |
| Transdermal patch 16.8 mg | Transdermal | 5 | .. | Durogesic 100 |
Ferrous Fumarate with Folic Acid | Tablet 310 mg (equivalent to 100 mg iron)‑350 micrograms | Oral | 60 | 1 | Ferro‑f‑tab |
Ferrous Sulfate | Oral liquid 30 mg per mL, 250 mL | Oral | 1 | 2 | Ferro‑Liquid |
Flecainide | Tablet containing flecainide acetate 50 mg | Oral | 60 | 5 | Tambocor |
| Tablet containing flecainide acetate 100 mg | Oral | 60 | 5 | Flecatab Tambocor |
Flucloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 250 |
| Capsule 500 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 500 |
| Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL | Oral | 1 |
| Aspen Pharmacare Australia Pty Limited |
| Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL | Oral | 1 | .. | Flopen |
| Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL | Oral | Oral |
| Aspen Pharmacare Australia Pty Limited |
| Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Flucil Flubiclox |
| Powder for injection 1 g (as sodium) | Injection | 5 | 1 | Flubiclox |
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| Flucil |
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| Hospira Pty Limited |
Fluconazole | Capsule 50 mg | Oral | 28 | 5 | DBL Fluconazole |
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| Diflucan |
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| Dizole 50 |
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| Fluconazole Hexal |
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| Fluzole 50 |
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| Ozole |
| Capsule 100 mg | Oral | 28 | 5 | DBL Fluconazole |
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| Diflucan |
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| Dizole 100 |
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| Fluconazole Hexal |
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| Fluconazole Winthrop |
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| Ozole |
| Capsule 200 mg | Oral | 28 | 5 | DBL Fluconazole |
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| Diflucan |
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| Dizole 200 |
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| Fluconazole Hexal |
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| Fluconazole Winthrop |
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| Fluzole 200 |
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| Ozole |
| Solution for I.V. infusion 100 mg in 50 mL | Injection | 7 | .. | Diflucan |
| Solution for I.V. infusion 200 mg in 100 mL | Injection | 7 | .. | Baxter Healthcare Pty Limited Diflucan |
| Solution for I.V. infusion 400 mg in 200 mL | Injection | 1 | .. | Baxter Healthcare Pty Limited |
Fludrocortisone | Tablet containing fludrocortisone acetate 100 micrograms | Oral | 200 | 1 | Florinef |
Fluorometholone | Eye drops 1 mg per mL, 5 mL | Application to the eye | 1 | 5 | Flucon FML Liquifilm |
| Eye drops containing fluorometholone acetate 1 mg per mL, 5 mL | Application to the eye | 1 | 2 | Flarex |
Fluorouracil | Injection 500 mg in 10 mL | Injection | 10 | .. | Fluorouracil Ebewe Hospira Pty Limited |
| Injection 1000 mg in 20 mL | Injection | 5 | .. | Fluorouracil Ebewe |
Fluoxetine | Tablet, dispersible, 20 mg (as hydrochloride) | Oral | 28 | 5 | Lovan 20 Tab Prozac Tab |
| Capsule 20 mg (as hydrochloride) | Oral | 28 | 5 | Auscap |
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| Chem mart Fluoxetine |
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| Fluohexal |
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| Fluoxebell |
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| Fluoxetine 20 |
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| Fluoxetine‑DP |
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| GenRx Fluoxetine |
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| Lovan |
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| Prozac 20 |
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| Terry White Chemists Fluoxetine |
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| Zactin |
Flupenthixol Decanoate | Oily I.M. injection 20 mg in 1 mL ampoule | Injection | 5 | .. | Fluanxol Depot |
| Oily I.M. injection 40 mg in 2 mL ampoule | Injection | 5 | .. | Fluanxol Depot |
| Oily I.M. injection 100 mg in 1 mL ampoule | Injection | 5 | .. | Fluanxol Concentrated Depot |
Fluphenazine Decanoate | Injection 12.5 mg in 0.5 mL ampoule | Injection | 5 | .. | Modecate |
| Injection 25 mg in 1 mL ampoule | Injection | 5 | .. | Modecate |
| Injection 50 mg in 2 mL ampoule | Injection | 5 | .. | Modecate |
Flurbiprofen | Eye drops containing flurbiprofen sodium 300 micrograms per mL, single dose units 0.4 mL, 5 | Application to the eye | 1 | .. | Ocufen |
Flutamide | Tablet 250 mg | Oral | 100 | 5 | Eulexin Flutamin |
Fluticasone | Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Flixotide Junior |
| Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Flixotide |
| Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 1 | Flixotide |
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Flixotide Junior Accuhaler |
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 5 | Flixotide Accuhaler |
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses | Inhalation by mouth | 1 | 1 | Flixotide Accuhaler |
Fluticasone with Salmeterol | Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Seretide MDI 50/25 |
| Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Seretide MDI 125/25 |
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Seretide Accuhaler 100/50 |
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Seretide Accuhaler 250/50 |
| Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Seretide MDI 250/25 |
| Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Seretide Accuhaler 500/50 |
Fluvastatin | Capsule 20 mg (as sodium) | Oral | 28 | 5 | Lescol Vastin |
| Capsule 40 mg (as sodium) | Oral | 28 | 5 | Lescol Vastin |
| Tablet (prolonged release) 80 mg (as sodium) | Oral | 28 | 5 | Lescol XL |
Fluvoxamine | Tablet containing fluvoxamine maleate 50 mg | Oral | 30 | 5 | Faverin 50 |
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| Luvox |
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| Movox 50 |
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| Voxam |
| Tablet containing fluvoxamine maleate 100 mg | Oral | 30 | 5 | Faverin 100 |
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| Luvox |
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| Movox 100 |
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| Voxam |
Folic Acid | Tablet 500 micrograms | Oral | 200 | .. | Megafol 0.5 |
| Tablet 5 mg | Oral | 200 | 1 | Megafol 5 |
Folinic acid | Tablet containing calcium folinate equivalent to 15 mg folinic acid | Oral | 10 | .. | Leucovorin Calcium (Hospira Australia Pty Limted) |
| Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL | Injection | 5 | 5 | Calcium Folinate Ebewe Leucovorin Calcium (Hospira Australia Pty Limted) Leucovorin Calcium (Pfizer Australia Pty Ltd) |
| Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL | Injection | 10 | 1 | Calcium Folinate Ebewe Leucovorin Calcium (Pfizer Australia Pty Ltd) |
| Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL | Injection | 4 | 1 | Leucovorin Calcium (Hospira Australia Pty Limted) |
Follitropin Alfa | Injection set containing 1 vial powder for injection 75 I.U. and 1 pre‑filled syringe solvent 1 mL | Injection | 5 | 5 | Gonal‑f 75 |
| Injection set containing 10 vials powder for injection 75 I.U. and 10 pre‑filled syringes solvent 1 mL | Injection | 1 | 5 | Gonal‑f 75 |
| Injection 300 I.U. in 0.5 mL multi‑dose cartridge | Injection | 3 | 5 | Gonal‑f Pen |
| Injection set containing 1 vial powder for injection 450 I.U. and 1 pre‑filled syringe solvent 1 mL | Injection | 3 | 5 | Gonal‑f |
| Injection 450 I.U. in 0.75 mL multi‑dose cartridge | Injection | 3 | 5 | Gonal‑f Pen |
| Injection 900 I.U. in 1.5 mL multi‑dose cartridge | Injection | 2 | 5 | Gonal‑f Pen |
| Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre‑filled syringe solvent 2 mL | Injection | 1 | 5 | Gonal‑f |
Follitropin Beta | Solution for injection 300 I.U. in 0.36 mL multi‑dose cartridge | Injection | 3 | 5 | Puregon 300 IU/0.36 mL |
| Solution for injection 600 I.U. in 0.72 mL multi‑dose cartridge | Injection | 2 | 5 | Puregon 600 IU/0.72 mL |
| Solution for injection 900 I.U. in 1.08 mL multi‑dose cartridge | Injection | 2 | 5 | Puregon 900 IU/1.08 mL |
Fondaparinux | Injection containing fondaparinux sodium 2.5 mg in 0.5 mL single dose pre‑filled syringe | Injection | 7 | .. | Arixtra |
Fosinopril | Tablet containing fosinopril sodium 10 mg | Oral | 30 | 5 | Fosinopril Sandoz |
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| Fosinopril Winthrop |
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| Fosipril 10 |
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| GenRx Fosinopril |
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| Monace 10 |
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| Monopril |
| Tablet containing fosinopril sodium 20 mg | Oral | 30 | 5 | Fosinopril Sandoz |
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| Fosinopril Winthrop |
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| Fosipril 20 |
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| GenRx Fosinopril |
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| Monace 20 |
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| Monopril |
Fosinopril with Hydrochlorothiazide | Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Fosinopril/HCT Sandoz 10mg/12.5mg Fosinopril/HCT Winthrop 10 mg/12.5 mg Hyforil Monoplus 10/12.5 |
| Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Fosinopril/HCT Sandoz 20mg/12.5mg Fosinopril/HCT Winthrop 20 mg/12.5 mg Hyforil Monoplus 20/12.5 |
Fotemustine | Powder for injection 208 mg with solvent | Injection | 1 | 4 | Muphoran |
Framycetin | Eye or ear drops containing framycetin sulfate 5 mg per mL, 8 mL | Application to the eye/ear | 1 | 2 | Soframycin |
Frusemide | Tablet 20 mg | Oral | 100 | 1 | Chem mart Frusemide |
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| Frusid |
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| GenRx Frusemide |
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| Lasix‑M |
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| Terry White Chemists Frusemide |
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| Urex‑M |
| Tablet 40 mg | Oral | 100 | 1 | Chem mart Frusemide |
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| Frusehexal 40 mg |
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| Frusid |
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| GenRx Frusemide |
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| Lasix |
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| Terry White Chemists Frusemide |
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| Uremide |
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| Urex |
| Tablet 500 mg | Oral | 50 | 3 | Urex‑Forte |
| Oral solution 10 mg per mL, 30 mL | Oral | 1 | 3 | Lasix |
| Injection 20 mg in 2 mL | Injection | 5 | .. | Frusehexal Lasix |
Fusidic Acid | Tablet containing sodium fusidate 250 mg | Oral | 36 | 1 | Fucidin |
Gabapentin | Capsule 100 mg | Oral | 100 | 5 | DBL Gabapentin |
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| Gantin |
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| Neurontin |
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| Nupentin 100 |
| Capsule 300 mg | Oral | 100 | 5 | DBL Gabapentin |
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| Douglas Gabapentin 300mg |
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| Gabahexal 300mg |
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| Gabapentin 300 |
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| Gantin |
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| GenRx Gabapentin |
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| Neurontin |
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| Nupentin 300 |
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| Pendine 300 |
| Capsule 400 mg | Oral | 100 | 5 | DBL Gabapentin |
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| Douglas Gabapentin 400mg |
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| Gabahexal 400mg |
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| Gabapentin 400 |
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| Gantin |
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| GenRx Gabapentin |
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| Neurontin |
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| Nupentin 400 |
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| Pendine 400 |
| Tablet 600 mg | Oral | 100 | 5 | Gabaran GenRx Gabapentin Neurontin |
| Tablet 800 mg | Oral | 100 | 5 | Gabaran |
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| Gantin |
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| GenRx Gabapentin |
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| Neurontin |
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| Pendine 800 |
Galantamine | Capsule (prolonged release) 8 mg (as hydrobromide) | Oral | 28 | 5 | Reminyl |
| Capsule (prolonged release) 16 mg (as hydrobromide) | Oral | 28 | 5 | Reminyl |
| Capsule (prolonged release) 24 mg (as hydrobromide) | Oral | 28 | 5 | Reminyl |
Gefitinib | Tablet 250 mg | Oral | 30 | 1 | Iressa |
Gelatin ‑ Succinylated | I.V. infusion 20 g per 500 mL, 500 mL | Injection | 3 | .. | Gelofusine |
Gemcitabine | Powder for I.V. infusion 200 mg (as hydrochloride) | Injection | 4 | 2 | Gemzar |
| Powder for I.V. infusion 1 g (as hydrochloride) | Injection | 2 | 2 | Gemzar |
Gemfibrozil | Tablet 600 mg | Oral | 60 | 5 | Ausgem |
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| Chem mart Gemfibrozil |
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| Gemhexal |
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| GenRx Gemfibrozil |
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| Jezil |
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| Lipazil 600 mg |
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| Lopid |
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| Pharmacor Gemfibrozil 600 |
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| Terry White Chemists Gemfibrozil |
Gentamicin | Injection 80 mg (as sulfate) in 2 mL | Injection | 10 | 1 | Hospira Pty Limited Pfizer Australia Pty Ltd |
| Eye drops 3 mg (as sulfate) per mL, 5 mL | Application to the eye | 1 | 2 | Genoptic |
Gestrinone | Capsule 2.5 mg | Oral | 8 | 5 | Dimetriose |
Glatiramer | Injection containing glatiramer acetate 20 mg in 1 mL single dose pre‑filled syringe | Injection | 28 | 5 | Copaxone |
Glibenclamide | Tablet 5 mg | Oral | 100 | 5 | Daonil Glimel |
Gliclazide | Tablet 30 mg (modified release) | Oral | 100 | 5 | Diamicron MR Oziclide MR |
| Tablet 80 mg | Oral | 100 | 5 | Chem mart Gliclazide |
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| Diamicron |
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| GenRx Gliclazide |
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| Glyade |
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| Mellihexal |
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| Nidem |
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| Terry White Chemists Gliclazide |
Glimepiride | Tablet 1 mg | Oral | 30 | 5 | Amaryl |
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| Aylide 1 |
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| Diapride 1 |
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| Dimirel |
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| Glimepiride Sandoz |
| Tablet 2 mg | Oral | 30 | 5 | Amaryl |
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| Aylide 2 |
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| Diapride 2 |
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| Dimirel |
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| Glimepiride Sandoz |
| Tablet 3 mg | Oral | 30 | 5 | Amaryl |
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| Aylide 3 |
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| Diapride 3 |
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| Dimirel |
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| Glimepiride Sandoz |
| Tablet 4 mg | Oral | 30 | 5 | Amaryl |
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| Aylide 4 |
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| Diapride 4 |
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| Dimirel |
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| Glimepiride Sandoz |
Glipizide | Tablet 5 mg | Oral | 100 | 5 | Melizide Minidiab |
Glucagon | Injection set containing glucagon hydrochloride 1 mg (1 I.U.) and 1 mL solvent in disposable syringe | Injection | 1 | 1 | GlucaGen Hypokit |
Glucose | I.V. infusion 278 mmol (anhydrous) per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Limited |
Glucose and Ketone Indicator—Urine | Reagent strips, 50 (Keto‑Diabur‑Test 5000) | For external use | 2 | 2 | Keto‑Diabur‑ Test 5000 |
| Reagent strips, 50 (Keto‑Diastix) | For external use | 2 | 2 | Keto‑Diastix |
Glucose Indicator—Blood | Electrode strips, 50 (Accu‑Chek Performa) | For external use | 2 | 5 | Accu‑Chek Performa |
| Electrode strips, 50 (Advantage II) | For external use | 2 | 5 | Advantage II |
| Electrode strips, 50 (Freestyle Papillon) | For external use | 2 | 5 | Freestyle Papillon |
| Electrode strips, 50 (Glucoboy) | For external use | 2 | 5 | Glucoboy |
| Electrode strips, 50 (Glucocard 01 Sensor) | For external use | 2 | 5 | Glucocard 01 Sensor |
| Electrode strips, 50 (GlucoCare Super Sensor) | For external use | 2 | 5 | GlucoCare Super Sensor |
| Electrode strips, 50 (GlucoOz) | For external use | 2 | 5 | GlucoOz |
| Electrode strips, 50 (MWD Pen Sensor Strips) | For external use | 2 | 5 | MWD Pen Sensor Strips |
| Electrode strips, 50 (Omnitest EZ) | For external use | 2 | 5 | Omnitest EZ |
| Electrode strips, 50 (Omnitest Plus) | For external use | 2 | 5 | Omnitest Plus |
| Electrode strips, 50 (Optium Omega) | For external use | 2 | 5 | Optium Omega |
| Electrode strips, 50 (Touch‑In Plus) | For external use | 2 | 5 | Touch‑In Plus |
| Electrode strips, 50 (TrueTrack) | For external use | 2 | 5 | TrueTrack |
| Electrode strips, 100 (FreeStyle Lite) | For external use | 1 | 5 | FreeStyle Lite |
| Electrode strips, 100 (Optium glucose) | For external use | 1 | 5 | Optium glucose |
| Electrode strips, 100 (Precision Plus) | For external use | 1 | 5 | Precision Plus |
| Electrode strips, 100 (SofTact) | For external use | 1 | 5 | SofTact |
| Electrode strips, 100 (TrueSense) | For external use | 1 | 5 | TrueSense |
| Reagent strips, 50 (Accu‑Chek Active) | For external use | 2 | 5 | Accu‑Chek Active |
| Reagent strips, 50 (Accu‑Chek Go) | For external use | 2 | 5 | Accu‑Chek Go |
| Reagent strips, 51 (Accu‑Chek Integra) | For external use | 2 | 5 | Accu‑Chek Integra |
| Reagent strips, 50 (Betachek) | For external use | 2 | 5 | Betachek |
| Reagent strips, 50 (Betachek G5) | For external use | 2 | 5 | Betachek G5 |
| Reagent strips, 50 (CareSens) | For external use | 2 | 5 | CareSens |
| Reagent strips, 50 (Glucoflex‑R) | For external use | 2 | 5 | Glucoflex‑R |
| Reagent strips, 50 (Glucostix) | For external use | 2 | 5 | Glucostix |
| Reagent strips, 50 (SensoCard) | For external use | 2 | 5 | SensoCard |
Glucose Indicator—Urine | Reagent strips, 50 (Clinistix) | For external use | 2 | 2 | Clinistix |
| Reagent strips, 50 (Diastix) | For external use | 2 | 2 | Diastix |
Glycerol | Suppositories 700 mg, 12 | Rectal | 3 | 5 | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 1.4 g, 12 | Rectal | 3 | 5 | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 2.8 g, 12 | Rectal | 3 | 5 | Petrus Pharmaceuticals Pty Ltd |
Glyceryl Trinitrate | Tablets 600 micrograms, 100 | Buccal/sublingual | 1 | 5 | Anginine Stabilised Lycinate |
| Sublingual spray (pump pack) 400 micrograms per dose, 200 doses | Sublingual | 1 | 5 | Nitrolingual Pumpspray |
| Transdermal patch 18 mg | Transdermal | 30 | 5 | Minitran 5 |
| Transdermal patch 25 mg | Transdermal | 30 | 5 | Transiderm‑Nitro 25 |
| Transdermal patch 40 mg | Transdermal | 30 | 5 | Nitro‑Dur 5 |
| Transdermal patch 36 mg | Transdermal | 30 | 5 | Minitran 10 |
| Transdermal patch 50 mg | Transdermal | 30 | 5 | Transiderm‑Nitro 50 |
| Transdermal patch 80 mg | Transdermal | 30 | 5 | Nitro‑Dur 10 |
| Transdermal patch 54 mg | Transdermal | 30 | 5 | Minitran 15 |
| Transdermal patch 120 mg | Transdermal | 30 | 5 | Nitro‑Dur 15 |
Goserelin | Subcutaneous implant 3.6 mg (as acetate) in pre‑filled injection syringe | Implantation | 1 | 5 | Zoladex Implant |
| Subcutaneous implant (long acting) 10.8 mg (as acetate) in pre‑filled injection syringe | Implantation | 1 | 1 | Zoladex 10.8 Implant |
Goserelin and Bicalutamide | Pack containing 1 subcutaneous implant containing goserelin 3.6 mg (as acetate) in pre‑filled injection syringe and 28 tablets bicalutamide 50 mg | Implantation/oral | 1 | 5 | ZolaCos CP 3.6/50 |
| Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre‑filled injection syringe and 28 tablets bicalutamide 50 mg | Implantation/oral | 1 | .. | ZolaCos CP 10.8/50(28) |
| Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre‑filled injection syringe and 84 tablets bicalutamide 50 mg | Implantation/oral | 1 | 1 | ZolaCos CP 10.8/50(84) |
Granisetron | Tablet 2 mg (as hydrochloride) | Oral | 2 | .. | Kytril |
| Concentrated injection 3 mg (as hydrochloride) in 3 mL | Injection | 1 | .. | Kytril |
Griseofulvin | Tablet 125 mg | Oral | 100 | 2 | Grisovin |
| Tablet 500 mg | Oral | 28 | 2 | Grisovin 500 |
Haloperidol | Tablet 500 micrograms | Oral | 100 | 5 | Serenace |
| Tablet 1.5 mg | Oral | 100 | 5 | Serenace |
| Tablet 5 mg | Oral | 50 | 5 | Serenace |
| Oral solution 2 mg per mL, 100 mL | Oral | 1 | 5 | Serenace |
| Injection 5 mg in 1 mL ampoule | Injection | 10 | .. | Serenace |
Haloperidol Decanoate | I.M. injection equivalent to 50 mg haloperidol in 1 mL ampoule | Injection | 5 | .. | Haldol decanoate |
| I.M. injection equivalent to 150 mg haloperidol in 3 mL ampoule | Injection | 5 | .. | Haldol decanoate |
Heparin | Injection 5,000 units (as sodium) in 0.2 mL | Injection | 5 | 5 | Hospira Pty Limited |
| Injection (preservative‑free) 5,000 I.U. (as sodium) in 5 mL | Injection | 50 | 5 | Pfizer Australia Pty Ltd |
| Injection 35,000 units (as sodium) in 35 mL | Injection | 12 | 5 | Hospira Pty Limited |
Hexamine | Tablet containing hexamine hippurate 1 g | Oral | 100 | 5 | Hiprex |
Homatropine | Eye drops containing homatropine hydrobromide 20 mg per mL, 15 mL | Application to the eye | 1 | 2 | Isopto Homatropine |
Hydralazine | Tablet containing hydralazine hydrochloride 25 mg | Oral | 200 | 2 | Alphapress 25 |
| Tablet containing hydralazine hydrochloride 50 mg | Oral | 200 | 2 | Alphapress 50 |
Hydrochlorothiazide | Tablet 25 mg | Oral | 100 | 1 | Dithiazide |
Hydrochlorothiazide with Amiloride | Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg | Oral | 100 | 1 | Moduretic |
Hydrochlorothiazide with Triamterene | Tablet 25 mg‑50 mg | Oral | 100 | 1 | Hydrene 25/50 |
Hydrocortisone | Tablet 4 mg | Oral | 50 | 4 | Hysone 4 |
| Tablet 20 mg | Oral | 60 | 4 | Hysone 20 |
| Injection 100 mg (as sodium succinate) with 2 mL solvent | Injection | 2 | .. | Solu‑Cortef |
| Injection 250 mg (as sodium succinate) with 2 mL solvent | Injection | 1 | .. | Solu‑Cortef |
| Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g | Application to the eye | 1 | .. | Hycor |
| Eye ointment containing hydrocortisone acetate 10 mg per g, 5 g | Application to the eye | 1 | .. | Hycor |
| Cream 10 mg per g, 50 g | Application | 1 | 1 | Egocort Cream 1% |
| Cream containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | 1 | Cortic‑DS 1% Sigmacort |
| Cream containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | 1 | Cortef Cortic‑DS 1% Sigmacort |
| Ointment containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | 1 | Cortic‑DS 1% Sigmacort |
| Ointment containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | 1 | Cortic‑DS 1% Sigmacort |
| Rectal foam containing hydrocortisone acetate 90 mg per applicatorful, 14 applications, aerosol 21.1 g | Rectal | 2 | 3 | Colifoam |
Hydromorphone | Tablet containing hydromorphone hydrochloride 2 mg | Oral | 20 | .. | Dilaudid |
| Tablet containing hydromorphone hydrochloride 4 mg | Oral | 20 | .. | Dilaudid |
| Tablet containing hydromorphone hydrochloride 8 mg | Oral | 20 | .. | Dilaudid |
| Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL | Oral | 1 | .. | Dilaudid |
| Injection containing hydromorphone hydrochloride 2 mg in 1 mL | Injection | 5 | .. | Dilaudid |
| Injection containing hydromorphone hydrochloride 10 mg in 1 mL | Injection | 5 | .. | Dilaudid‑HP |
| Injection containing hydromorphone hydrochloride 50 mg in 5 mL | Injection | 5 | .. | Dilaudid‑HP |
| Injection containing hydromorphone hydrochloride 500 mg in 50 mL | Injection | 1 | .. | Dilaudid‑HP |
Hydroxocobalamin | Injection 1 mg in 1 mL | Injection | 3 | .. | Neo‑B12 |
Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200 mg | Oral | 100 | 1 | Plaquenil |
Hydroxyurea | Capsule 500 mg | Oral | 100 | .. | Hydrea |
Hypromellose | Eye drops 3 mg per mL, 15 mL | Application to the eye | 1 | 5 | Genteal In a Wink Moisturising |
| Eye drops 5 mg per mL, 15 mL | Application to the eye | 1 | 5 | Methopt |
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg‑2 mg per g, 10 g | Application to the eye | 1 | 5 | Genteal gel HPMC PAA |
Hypromellose with Dextran | Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL | Application to the eye | 1 | 5 | Poly‑Tears Tears Naturale |
| Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28 | Application to the eye | 3 | 5 | Bion Tears |
Ibuprofen | Tablet 200 mg | Oral | 100 | 3 | Rafen 200 |
| Tablet 400 mg | Oral | 30 | .. | Brufen |
Idarubicin | Capsule containing idarubicin hydrochloride 5 mg | Oral | 3 | .. | Zavedos |
| Capsule containing idarubicin hydrochloride 10 mg | Oral | 3 | .. | Zavedos |
| Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL single use vial | Injection | 3 | .. | Zavedos Solution |
| Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL single use vial | Injection | 6 | .. | Zavedos Solution |
Ifosfamide | Powder for I.V. injection 1 g in single dose vial | Injection | 5 | 5 | Holoxan |
| Powder for I.V. injection 2 g in single dose vial | Injection | 5 | 5 | Holoxan |
Imatinib | Tablet 100 mg (as mesylate) | Oral | 60 | 2 | Glivec |
| Tablet 400 mg (as mesylate) | Oral | 30 | 2 | Glivec |
Imipramine | Tablet containing imipramine hydrochloride 10 mg | Oral | 50 | 2 | Tofranil 10 Tolerade 10 |
| Tablet containing imipramine hydrochloride 25 mg | Oral | 50 | 2 | Tofranil 25 Tolerade 25 |
Imiquimod | Cream 50 mg per g, 250 mg single use sachets, 12 | Application | 1 | 1 | Aldara |
Indapamide | Tablet containing indapamide hemihydrate 1.5 mg (sustained release) | Oral | 90 | 1 | Natrilix SR |
| Tablet containing indapamide hemihydrate 2.5 mg | Oral | 90 | 1 | Chem mart Indapamide |
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| Dapa‑Tabs |
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| GenRx Indapamide |
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| Indahexal |
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| Insig |
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| Napamide 2.5 mg |
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| Natrilix |
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| Terry White Chemists Indapamide |
Indomethacin | Capsule 25 mg | Oral | 100 | 3 | Arthrexin Indocid |
| Suppository 100 mg | Rectal | 40 | 3 | Indocid |
Influenza Vaccine | Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/Solomon Islands/3/2006 (H1N1)‑like strain 7.5 micrograms haemagglutinin; A/Brisbane/10/2007 (H3N2)‑like strain 7.5 micrograms haemagglutinin; B/Florida/4/2006‑like strain 7.5 micrograms haemagglutinin; 0.25 mL pre‑filled syringe | Injection | 1 | .. | Fluvax Junior Vaxigrip Junior |
| Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/Solomon Islands/3/2006 (H1N1)‑like strain 15 micrograms haemagglutinin; A/Brisbane/10/2007 (H3N2)‑like strain 15 micrograms haemagglutinin; B/Florida/4/2006‑like strain 15 micrograms haemagglutinin; 0.5 mL pre‑filled syringe | Injection | 1 | .. | Fluvax Influvac Vaxigrip |
Insect Allergen Extract—Honey Bee Venom | Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL | Injection | 1 | .. | Albey Bee Venom |
Insect Allergen Extract—Paper Wasp Venom | Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL | Injection | 1 | .. | Albey Paper Wasp Venom |
Insect Allergen Extract—Yellow Jacket Venom | Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL | Injection | 1 | .. | Albey Yellow Jacket Venom |
Insulin Aspart | Injection (human analogue) 100 units per mL, 10 mL vial | Injection | 5 | 2 | NovoRapid |
| Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | NovoRapid FlexPen NovoRapid Penfill 3 mL |
Insulin Aspart with Insulin Aspart Protamine Suspension | Injections (human analogue), cartridges, 30 units‑70 units per mL, 3 mL, 5 | Injection | 5 | 1 | NovoMix 30 FlexPen NovoMix 30 Penfill 3 mL |
Insulin Detemir | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Levemir FlexPen Levemir Penfill |
Insulin Glargine | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Lantus Lantus SoloStar |
Insulin Glulisine | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Apidra SoloStar |
Insulin Isophane | Injection (bovine) 100 units per mL, 10 mL | Injection | 5 | 2 | Hypurin Isophane |
| Injection (human) 100 units per mL, 10 mL | Injection | 5 | 2 | Humulin NPH Protaphane |
| Injections (human), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humulin NPH |
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| Protaphane InnoLet |
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| Protaphane NovoLet 3 mL |
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| Protaphane Penfill 3 mL |
Insulin Lispro | Injection (human analogue) 100 units per mL, 10 mL vial | Injection | 5 | 2 | Humalog |
| Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humalog |
Insulin Lispro with Insulin Lispro Protamine Suspension | Injections (human analogue), cartridges, 25 units‑75 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humalog Mix25 |
| Injections (human analogue), cartridges, 50 units‑50 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humalog Mix50 |
Insulin Neutral | Injection (bovine) 100 units per mL, 10 mL | Injection | 5 | 2 | Hypurin Neutral |
| Injection (human) 100 units per mL, 10 mL | Injection | 5 | 2 | Actrapid Humulin R |
| Injections (human), cartridges, 100 units per mL, 3 mL, 5 | Injection | 5 | 1 | Actrapid Penfill 3 mL Humulin R |
Insulin Neutral with Insulin Isophane | Injection (human) 30 units‑70 units per mL, 10 mL | Injection | 5 | 2 | Humulin 30/70 |
| Injections (human), cartridges, 30 units‑70 units per mL, 3 mL, 5 | Injection | 5 | 1 | Humulin 30/70 Mixtard 30/70 InnoLet Mixtard 30/70 Penfill 3 mL |
| Injections (human), cartridges, 50 units‑50 units per mL, 3 mL, 5 | Injection | 5 | 1 | Mixtard 50/50 Penfill 3 mL |
Interferon Alfa‑2a | Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | 15 | 4 | Roferon‑A |
| Injection 4,500,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | 5 | 4 | Roferon‑A |
| Injection 6,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | 5 | 4 | Roferon‑A |
| Injection 9,000,000 I.U. in 0.5 mL single dose pre‑filled syringe | Injection | 5 | 4 | Roferon‑A |
Interferon Alfa‑2b | Solution for injection 18,000,000 I.U. in 1.2 mL multi‑dose injection pen | Injection | 3 | 4 | Intron A Redipen |
| Solution for injection 30,000,000 I.U. in 1.2 mL multi‑dose injection pen | Injection | 3 | 5 | Intron A Redipen |
Interferon Beta‑1a | Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent | Injection | 4 | 5 | Avonex |
| Injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single dose pre‑filled syringe | Injection | 4 | 5 | Avonex |
| Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre‑filled syringe | Injection | 12 | 5 | Rebif 44 |
Interferon Beta‑1b | Injection set comprising 1 vial powder for injection 8,000,000 I.U. (250 micrograms) and solvent | Injection | 15 | 5 | Betaferon |
Ipratropium | Pressurised inhalation containing ipratropium bromide 21 micrograms per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 2 | 5 | Atrovent |
| Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 | Inhalation | 2 | 5 | Aeron 250 Apoven 250 Atrovent Chem mart Ipratropium GenRx Ipratropium Ipratrin Ipravent Terry White Chemists Ipratropium |
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| Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 | Inhalation | 2 | 5 | Aeron 500 Apoven 500 Atrovent Adult |
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| Chem mart Ipratropium |
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| GenRx Ipratropium |
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| Ipratrin Adult |
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| Ipravent |
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| Terry White Chemists Ipratropium |
Irbesartan | Tablet 75 mg | Oral | 30 | 5 | Avapro Karvea |
| Tablet 150 mg | Oral | 30 | 5 | Avapro Karvea |
| Tablet 300 mg | Oral | 30 | 5 | Avapro Karvea |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg‑12.5 mg | Oral | 30 | 5 | Avapro HCT 150/12.5 Karvezide 150/12.5 |
| Tablet 300 mg‑12.5 mg | Oral | 30 | 5 | Avapro HCT 300/12.5 Karvezide 300/12.5 |
| Tablet 300 mg‑25 mg | Oral | 30 | 5 | Avapro HCT 300/25 Karvezide 300/25 |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Injection | 1 | 3 | Camptosar Hospira Pty Limited Irinotecan Sandoz |
| I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Injection | 2 | 3 | Camptosar Hospira Pty Limited Irinotecan Sandoz |
| I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL | Injection | 1 | 3 | Hospira Pty Limited |
Iron Polymaltose Complex | Injection 100 mg (iron) in 2 mL ampoule | Injection | 5 | .. | Ferrosig Ferrum H |
Iron Sucrose | Concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL ampoule | Injection | 5 | .. | Venofer |
Isoleucine with carbohydrate | Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine Amino Acid Supplement) | Oral | 4 | 5 | Isoleucine Amino Acid Supplement |
Isoniazid | Tablet 100 mg | Oral | 100 | 2 | Fawns and McAllan Proprietary Limited |
Isosorbide Dinitrate | Tablet 10 mg | Oral | 200 | 2 | Sorbidin |
| Tablet 5 mg (sublingual) | Oral | 200 | 2 | Isordil Sublingual |
Isosorbide Mononitrate | Tablet 60 mg (sustained release) | Oral | 30 | 5 | Chem mart Isosorbide Mononitrate |
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| Duride |
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| GenRx Isosorbide Mononitrate |
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| Imdur Durule |
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| Imtrate 60 mg |
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| Isomonit |
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| Monodur 60 mg |
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| Terry White Chemists Isosorbide Mononitrate |
| Tablet 120 mg (sustained release) | Oral | 30 | 5 | Imdur 120 mg Monodur 120 mg |
Isotretinoin | Capsule 10 mg | Oral | 60 | 3 | GenRx Isotretinoin Oratane Roaccutane |
| Capsule 20 mg | Oral | 60 | 3 | Chem mart Isotretinoin |
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| GenRx Isotretinoin |
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| Oratane |
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| Roaccutane |
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| Terry White Chemists Isotretinoin |
| Capsule 40 mg | Oral | 30 | 3 | Oratane |
Itraconazole | Capsule 100 mg | Oral | 60 | 5 | Sporanox |
Ivermectin | Tablet 3 mg | Oral | 4 | .. | Stromectol |
Ketoconazole | Tablet 200 mg | Oral | 10 | .. | Nizoral |
| Cream 20 mg per g, 30 g | Application | 1 | 2 | Nizoral 2% Cream |
| Shampoo 10 mg per g, 100 mL | Application | 1 | 1 | Nizoral 1% |
| Shampoo 20 mg per g, 60 mL | Application | 1 | 1 | Nizoral 2% |
Ketoprofen | Capsule 200 mg (sustained release) | Oral | 28 | 3 | Orudis SR 200 Oruvail SR |
| Suppository 100 mg | Rectal | 40 | 3 | Orudis |
Labetalol | Tablet containing labetalol hydrochloride 100 mg | Oral | 100 | 5 | Presolol 100 Trandate |
| Tablet containing labetalol hydrochloride 200 mg | Oral | 100 | 5 | Presolol 200 Trandate |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | Oral | 1 | 5 | Actilax |
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| Duphalac |
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| Genlac |
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| GenRx Lactulose |
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| Lac‑Dol |
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| Lactocur |
Lamotrigine | Tablet 5 mg | Oral | 56 | 5 | Elmendos |
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| Lamictal |
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| Lamitrin |
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| Lamogine |
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| Seaze 5 |
| Tablet 25 mg | Oral | 56 | 5 | Elmendos |
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| GenRx Lamotrigine |
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| Lamictal |
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| Lamidus |
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| Lamitrin |
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| Lamogine |
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| Lamotrigine‑DP |
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| Lamotrigine generichealth |
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| Seaze 25 |
| Tablet 50 mg | Oral | 56 | 5 | Elmendos |
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| GenRx Lamotrigine |
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| Lamictal |
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| Lamidus |
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| Lamitrin |
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| Lamogine |
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| Lamotrigine‑DP |
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| Lamotrigine generichealth |
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| Seaze 50 |
| Tablet 100 mg | Oral | 56 | 5 | Elmendos |
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| GenRx Lamotrigine |
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| Lamictal |
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| Lamidus |
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| Lamitrin |
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| Lamogine |
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| Lamotrigine‑DP |
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| Lamotrigine generichealth |
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| Seaze 100 |
| Tablet 200 mg | Oral | 56 | 5 | Elmendos |
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| GenRx Lamotrigine |
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| Lamictal |
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| Lamidus |
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| Lamitrin |
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| Lamogine |
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| Lamotrigine‑DP |
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| Lamotrigine generichealth |
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| Seaze 200 |
Lansoprazole | Capsule 30 mg | Oral | 30 | 1 | Zoton |
| Sachet containing granules for oral suspension, 30 mg per sachet | Oral | 28 | 1 | Zoton |
| Capsule 15 mg | Oral | 30 | 5 | Zoton |
Lapatinib | Tablet 250 mg (as ditosylate monohydrate) | Oral | 140 | 2 | Tykerb |
Latanoprost | Eye drops 50 micrograms per mL, 2.5 mL | Application to the eye | 1 | 5 | Xalatan |
Latanoprost with Timolol | Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Xalacom |
Leflunomide | Pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg | Oral | 1 | .. | Arava |
| Tablet 10 mg | Oral | 30 | 5 | Arabloc Arava |
| Tablet 20 mg | Oral | 30 | 5 | Arabloc Arava |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg | Oral | 30 | 5 | Zanidip |
| Tablet containing lercanidipine hydrochloride 20 mg | Oral | 30 | 5 | Zanidip |
Lercanidipine with enalapril | Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 10 mg | Oral | 30 | 5 | Zan-Extra 10/10 |
| Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 20 mg | Oral | 30 | 5 | Zan-Extra 10/20 |
Letrozole | Tablet 2.5 mg | Oral | 30 | 5 | Femara 2.5 mg |
Leuprorelin | I.M. injection (modified release), powder for injection containing leuprorelin acetate 7.5 mg with diluent in pre‑filled dual‑chamber syringe | Injection | 1 | 5 | Lucrin Depot 7.5mg PDS |
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 7.5 mg, injection set | Injection | 1 | 5 | Eligard 1 month |
| I.M. injection (modified release), powder for injection containing leuprorelin acetate 22.5 mg with diluent in pre‑filled dual‑chamber syringe | Injection | 1 | 1 | Lucrin Depot 3 Month PDS |
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 22.5 mg, injection set | Injection | 1 | 1 | Eligard 3 month |
| I.M. injection (modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre‑filled dual‑chamber syringe | Injection | 1 | 1 | Lucrin Depot 4 Month PDS |
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 30 mg, injection set | Injection | 1 | 1 | Eligard 4 month |
| Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set | Injection | 1 | .. | Eligard 6 month |
Levetiracetam | Tablet 250 mg | Oral | 60 | 5 | Keppra |
| Tablet 500 mg | Oral | 60 | 5 | Keppra |
| Tablet 1 g | Oral | 60 | 5 | Keppra |
Levobunolol | Eye drops containing levobunolol hydrochloride 2.5 mg per mL, 5 mL | Application to the eye | 1 | 5 | Betagan |
Levodopa with Benserazide | Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar Rapid 62.5 |
| Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar Rapid 125 |
| Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar 125 |
| Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar |
| Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar 62.5 |
| Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar 125 |
| Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release) | Oral | 100 | 5 | Madopar HBS |
| Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride) | Oral | 100 | 5 | Madopar |
Levodopa with Carbidopa | Tablet 200 mg‑50 mg (anhydrous) (modified release) | Oral | 100 | 5 | Sinemet CR |
| Tablet 100 mg‑25 mg (anhydrous) | Oral | 100 | 5 | Kinson Sinemet 100/25 |
| Tablet 250 mg‑25 mg (anhydrous) | Oral | 100 | 5 | Levohexal Sinemet |
Levodopa with Carbidopa and Entacapone | Tablet 50 mg‑12.5 mg‑200 mg | Oral | 200 | 4 | Stalevo 50/12.5/200mg |
| Tablet 100 mg‑25 mg‑200 mg | Oral | 200 | 4 | Stalevo 100/25/200mg |
| Tablet 150 mg‑37.5 mg‑200 mg | Oral | 200 | 4 | Stalevo 150/37.5/200mg |
Levonorgestrel | Tablets 30 micrograms, 28 | Oral | 4 | 2 | Microlut 28 |
| Intrauterine drug delivery system 52 mg | Intrauterine | 1 | .. | Mirena |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 125 micrograms‑50 micrograms and 7 inert tablets | Oral | 4 | 2 | Microgynon 50 ED |
| Tablets 150 micrograms‑30 micrograms, 21 | Oral | 4 | 2 | Microgynon 30 |
| Pack containing 21 tablets 150 micrograms‑30 micrograms and 7 inert tablets | Oral | 4 | 2 | Levlen ED |
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| Microgynon 30 ED |
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| Monofeme 28 |
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| Nordette 28 |
| Pack containing 6 tablets 50 micrograms‑30 micrograms, 5 tablets 75 micrograms‑40 micrograms, 10 tablets 125 micrograms‑30 micrograms and 7 inert tablets | Oral | 4 | 2 | Logynon ED |
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| Trifeme 28 |
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| Triphasil 28 |
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| Triquilar ED |
Lignocaine | Injection containing lignocaine hydrochloride 100 mg in 5 mL | Injection | 5 | .. | Pfizer Australia Pty Ltd |
| Infusion containing lignocaine hydrochloride 500 mg in 5 mL | Injection | 10 | .. | Xylocard 500 |
Lincomycin | Injection 600 mg (as hydrochloride) in 2 mL | Injection | 5 | .. | Lincocin |
Liothyronine | Tablet containing liothyronine sodium 20 micrograms | Oral | 100 | 2 | Tertroxin |
Lisinopril | Tablet 5 mg | Oral | 30 | 5 | Chem mart Lisinopril |
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| Fibsol 5 |
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| GenRx Lisinopril |
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| Liprace |
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| Lisinobell |
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| Lisinopril 5 |
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| Lisinopril Hexal |
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| Lisinopril Winthrop |
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| Lisodur |
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| Prinivil 5 |
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| Terry White Chemists Lisinopril |
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| Zestril |
| Tablet 10 mg | Oral | 30 | 5 | Chem mart Lisinopril |
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| Fibsol 10 |
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| GenRx Lisinopril |
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| Liprace |
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| Lisinobell |
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| Lisinopril 10 |
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| Lisinopril Hexal |
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| Lisinopril Winthrop |
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| Lisodur |
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| Prinivil 10 |
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| Terry White Chemists Lisinopril |
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| Zestril |
| Tablet 20 mg | Oral | 30 | 5 | Chem mart Lisinopril |
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| Fibsol 20 |
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| GenRx Lisinopril |
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| Liprace |
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| Lisinobell |
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| Lisinopril 20 |
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| Lisinopril generichealth |
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| Lisinopril Hexal |
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| Lisinopril Winthrop |
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| Lisodur |
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| Prinivil 20 |
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| Terry White Chemists Lisinopril |
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| Zestril |
Lithium | Tablet containing lithium carbonate 250 mg | Oral | 200 | 2 | Lithicarb |
| Tablet containing lithium carbonate 450 mg (slow release) | Oral | 200 | 2 | Quilonum SR |
Loperamide | Capsule containing loperamide hydrochloride 2 mg | Oral | 12 | .. | Gastro‑Stop Loperamide Imodium |
Macrogol 3350 | Sachets containing powder for oral solution 6.563 g with electrolytes, 30 | Oral | 1 | 5 | Movicol-Half |
| Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Oral | 1 | 5 | Movicol |
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 500 mg | Oral | 30 | 2 | Provera |
| Tablet containing medroxyprogesterone acetate 100 mg | Oral | 100 | 2 | Provera |
| Tablet containing medroxyprogesterone acetate 200 mg | Oral | 60 | 2 | Provera |
| Tablet containing medroxyprogesterone acetate 250 mg | Oral | 60 | 2 | Provera |
| Tablet containing medroxyprogesterone acetate 5 mg | Oral | 56 | 2 | Provera Ralovera |
| Tablet containing medroxyprogesterone acetate 10 mg | Oral | 30 | 2 | Medroxyhexal Provera Ralovera |
| Injection containing medroxyprogesterone acetate 50 mg in 1 mL | Injection | 1 | 1 | Depo‑Provera |
| Injection containing medroxyprogesterone acetate 150 mg in 1 mL | Injection | 1 | 1 | Depo‑Provera Depo‑Ralovera |
Mefenamic Acid | Capsule 250 mg | Oral | 50 | 2 | Ponstan |
Megestrol | Tablet containing megestrol acetate 160 mg | Oral | 30 | 2 | Megace |
Meloxicam | Tablet 7.5 mg | Oral | 30 | 3 | Chem mart Meloxicam 7.5 mg |
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| GenRx Meloxicam |
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| Meloxibell |
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| Meloxicam‑GA |
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| Meloxicam Ranbaxy |
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| Meloxicam Sandoz |
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| Meloxicam Winthrop |
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| Mobic |
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| Movalis 7.5 |
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| Moxicam 7.5 |
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| Pharmacor Meloxicam 7.5 |
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| Terry White Chemists Meloxicam 7.5 mg |
| Tablet 15 mg | Oral | 30 | 3 | Chem mart Meloxicam 15 mg |
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| GenRx Meloxicam |
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| Meloxibell |
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| Meloxicam‑GA |
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| Meloxicam Ranbaxy |
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| Meloxicam Sandoz |
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| Meloxicam Winthrop |
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| Mobic |
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| Movalis 15 |
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| Moxicam 15 |
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| Pharmacor Meloxicam 15 |
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| Terry White Chemists Meloxicam 15 mg |
| Capsule 7.5 mg | Oral | 30 | 3 | Mobic |
| Capsule 15 mg | Oral | 30 | 3 | Mobic |
Melphalan | Tablet 2 mg | Oral | 25 | 1 | Alkeran |
Memantine | Tablet containing memantine hydrochloride 10 mg | Oral | 56 | 5 | Ebixa |
| Oral drops containing memantine hydrochloride 10 mg | Oral | 1 | 5 | Ebixa |
Mercaptopurine | Tablet 50 mg | Oral | 100 | 2 | Purinethol |
Mesalazine | Tablet 250 mg (enteric coated) | Oral | 100 | 5 | Mesasal |
| Tablet 500 mg (enteric coated) | Oral | 200 | 5 | Salofalk |
| Tablet 500 mg (prolonged release) | Oral | 100 | 5 | Pentasa |
| Sachet containing prolonged release granules, 1 g per sachet | Oral | 100 | 5 | Pentasa |
| Sachet containing prolonged release granules, 2 g per sachet | Oral | 60 | 5 | Pentasa |
| Sachet containing granules, 500 mg per sachet | Oral | 200 | 5 | Salofalk |
| Sachet containing granules, 1 g per sachet | Oral | 100 | 5 | Salofalk |
| Suppositories 1 g, 28 | Rectal | 1 | .. | Pentasa |
| Enemas 1 g in 100 mL, 7 | Rectal | 4 | .. | Pentasa |
| Enemas 2 g in 60 mL, 7 | Rectal | 4 | .. | Salofalk |
| Enemas 4 g in 60 mL, 7 | Rectal | 4 | .. | Salofalk |
| Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g | Rectal | 4 | .. | Salofalk |
Mesna | Solution for I.V. injection 400 mg in 4 mL ampoule | Injection | 15 | 5 | Uromitexan |
| Solution for I.V. injection 1 g in 10 mL ampoule | Injection | 15 | 5 | Uromitexan |
Metformin | Tablet containing metformin hydrochloride 500 mg | Oral | 100 | 5 | Chem mart Metformin |
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| Diabex |
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| Diaformin |
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| Formet 500 |
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| GenRx Metformin |
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| Glucohexal |
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| Glucomet 500 mg |
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| Glucophage |
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| Genepharm Pty Ltd |
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| Metforbell |
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| Metformin 500 |
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| Terry White Chemists Metformin |
| Tablet containing metformin hydrochloride 500 mg (extended release) | Oral | 90 | 5 | Diabex XR |
| Tablet containing metformin hydrochloride 850 mg | Oral | 60 | 5 | Chem mart Metformin |
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| Diabex 850 |
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| Diaformin 850 |
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| Formet 850 |
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| GenRx Metformin |
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| Glucohexal |
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| Glucomet 850 mg |
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| Glucophage |
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| Genepharm Pty Ltd |
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| Metforbell |
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| Metformin 850 |
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| Terry White Chemists Metformin |
| Tablet containing metformin hydrochloride 1 g | Oral | 90 | 5 | Diabex 1000 |
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| Diaformin 1000 |
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| Formet 1000 |
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| Glucohexal |
Metformin with Glibenclamide | Tablet containing metformin hydrochloride 250 mg with glibenclamide 1.25 mg | Oral | 90 | 5 | Glucovance 250mg/1.25mg |
| Tablet containing metformin hydrochloride 500 mg with glibenclamide 2.5 mg | Oral | 90 | 5 | Glucovance 500mg/2.5mg |
| Tablet containing metformin hydrochloride 500 mg with glibenclamide 5 mg | Oral | 90 | 5 | Glucovance 500mg/5mg |
Methadone | Tablet containing methadone hydrochloride 10 mg | Oral | 20 | .. | Physeptone |
| Injection containing methadone hydrochloride 10 mg in 1 mL | Injection | 5 | .. | Physeptone |
Methotrexate | Tablet 2.5 mg | Oral | 30 | 5 | Methoblastin Hospira Pty Limited |
| Tablet 10 mg | Oral | 15 | 1 | Methoblastin |
| Injection 5 mg in 2 mL vial | Injection | 5 | .. | Hospira Pty Limited |
| Injection 50 mg in 2 mL vial | Injection | 5 | .. | Hospira Pty Limited Pfizer Australia Pty Ltd |
| Solution concentrate for I.V. infusion 500 mg in 5 mL vial | Injection | 1 | .. | Methotrexate Ebewe |
| Solution concentrate for I.V. infusion 500 mg in 20 mL vial | Injection | 1 | .. | Hospira Pty Limited |
| Solution concentrate for I.V. infusion 1000 mg in 10 mL vial | Injection | 1 | .. | Methotrexate Ebewe Hospira Pty Limited |
| Solution concentrate for I.V. infusion 5000 mg in 50 mL vial | Injection | 1 | .. | Methotrexate Ebewe |
Methyldopa | Tablet 250 mg | Oral | 100 | 5 | Aldomet Hydopa |
Methylphenidate | Tablet containing methylphenidate hydrochloride 10 mg | Oral | 100 | 5 | Attenta Ritalin 10 |
| Tablet containing methylphenidate hydrochloride 18 mg (extended release) | Oral | 30 | 5 | Concerta |
| Tablet containing methylphenidate hydrochloride 27 mg (extended release) | Oral | 30 | 5 | Concerta |
| Tablet containing methylphenidate hydrochloride 36 mg (extended release) | Oral | 30 | 5 | Concerta |
| Tablet containing methylphenidate hydrochloride 54 mg (extended release) | Oral | 30 | 5 | Concerta |
| Capsule containing methylphenidate hydrochloride 20 mg (modified release) | Oral | 30 | 5 | Ritalin LA |
| Capsule containing methylphenidate hydrochloride 30 mg (modified release) | Oral | 30 | 5 | Ritalin LA |
| Capsule containing methylphenidate hydrochloride 40 mg (modified release) | Oral | 30 | 5 | Ritalin LA |
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Injection | 5 | .. | Depo‑Medrol Depo‑Nisolone |
| Powder for injection 40 mg (as sodium succinate) with diluent | Injection | 5 | .. | Solu‑Medrol |
| Powder for injection 1 g (as sodium succinate) with diluent | Injection | 1 | .. | Solu‑Medrol |
| Cream containing methylprednisolone aceponate 1 mg per g, 15 g | Application | 1 | .. | Advantan |
| Ointment containing methylprednisolone aceponate 1 mg per g, 15 g | Application | 1 | .. | Advantan |
| Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g | Application | 1 | .. | Advantan |
| Lotion containing methylprednisolone aceponate 1 mg per g, 20 g | Application | 1 | .. | Advantan |
Methysergide | Tablet 1 mg (as maleate) | Oral | 100 | 2 | Deseril |
Metoclopramide | Tablet containing metoclopramide hydrochloride 10 mg | Oral | 25 | .. | Maxolon Pramin |
| Injection containing metoclopramide hydrochloride 10 mg in 2 mL | Injection | 10 | .. | Maxolon |
Metoprolol | Tablet containing metoprolol tartrate 50 mg | Oral | 100 | 5 | Betaloc |
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| Chem mart Metoprolol |
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| GenRx Metoprolol |
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| Lopresor 50 |
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| Metohexal |
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| Metolol |
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| Metrol 50 |
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| Minax 50 |
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| Terry White Chemists Metoprolol |
| Tablet containing metoprolol tartrate 100 mg | Oral | 60 | 5 | Betaloc |
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| Chem mart Metoprolol |
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| GenRx Metoprolol |
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| Lopresor 100 |
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| Metohexal |
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| Metolol |
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| Metrol 100 |
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| Minax 100 |
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| Terry White Chemists Metoprolol |
Metoprolol succinate | Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release) | Oral | 1 | .. | Toprol‑XL Titration Pack |
| Tablet 23.75 mg (controlled release) | Oral | 15 | .. | Toprol‑XL 23.75 |
| Tablet 47.5 mg (controlled release) | Oral | 30 | 5 | Toprol‑XL 47.5 |
| Tablet 95 mg (controlled release) | Oral | 30 | 5 | Toprol‑XL 95 |
| Tablet 190 mg (controlled release) | Oral | 30 | 5 | Toprol‑XL 190 |
Metronidazole | Tablet 200 mg | Oral | 21 | 1 | Flagyl Metrogyl 200 Metronide 200 |
| Tablet 400 mg | Oral | 5 | 2 | Metrogyl 400 |
| Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL | Oral | 1 | .. | Flagyl S |
| I.V. infusion 500 mg in 100 mL | Injection | 5 | 1 | Baxter Healthcare Pty Limited DBL Metronidazole Intravenous Infusion Metronidazole Sandoz |
| Suppositories 500 mg, 10 | Rectal | 1 | .. | Flagyl |
Mexiletine | Capsule containing mexiletine hydrochloride 50 mg | Oral | 100 | 5 | Mexitil |
| Capsule containing mexiletine hydrochloride 200 mg | Oral | 100 | 5 | Mexitil |
Mianserin | Tablet containing mianserin hydrochloride 10 mg | Oral | 50 | 5 | Lumin 10 Tolvon |
| Tablet containing mianserin hydrochloride 20 mg | Oral | 50 | 5 | Lumin 20 Tolvon |
Miconazole | Cream containing miconazole nitrate 20 mg per g, 15 g | Application | 2 | 3 | Daktarin |
| Cream containing miconazole nitrate 20 mg per g, 30 g | Application | 1 | 2 | Daktarin |
| Cream containing miconazole nitrate 20 mg per g, 70 g | Application | 1 | 1 | Daktarin |
| Powder containing miconazole nitrate 20 mg per g, 30 g | Application | 1 | 2 | Daktarin |
| Tincture 20 mg per mL, 30 mL | Application | 1 | 2 | Daktarin |
| Lotion containing miconazole nitrate 20 mg per mL, 30 g | Application | 1 | 2 | Daktarin |
Milk powder — lactose free formula | Oral powder 900 g (S‑26 LF) | Oral | 5 | .. | S‑26 LF |
| Oral powder 900 g (Karicare De‑Lact) | Oral | 5 | .. | Karicare De‑Lact |
Milk powder — lactose modified | Oral powder 900 g (Digestelact) | Oral | 3 | 1 | Digestelact |
Milk powder — synthetic | Low calcium oral powder 400 g (Locasol) | Oral | 8 | 5 | Locasol |
Milk protein and fat formula with vitamins and minerals — carbohydrate free | Oral powder 225 g (Carbohydrate Free Mixture) | Oral | 24 | 5 | Carbohydrate Free Mixture |
Mineral mixture | Oral powder 250 g (Metabolic Mineral Mixture) | Oral | 1 | 5 | Metabolic Mineral Mixture |
Minocycline | Tablet 50 mg (as hydrochloride) | Oral | 60 | 5 | Akamin 50 Minomycin‑50 |
| Capsule 100 mg (as hydrochloride) | Oral | 11 | .. | Akamin 100 |
Minoxidil | Tablet 10 mg | Oral | 100 | 5 | Loniten |
Mirtazapine | Tablet 15 mg (orally disintegrating) | Oral | 30 | 5 | Avanza SolTab |
| Tablet 30 mg | Oral | 30 | 5 | Avanza |
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| Axit 30 |
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| Chem mart Mirtazapine |
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| GenRx Mirtazapine |
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| Mirtazapine‑DP |
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| Mirtazapine Sandoz |
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| Mirtazon |
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| Terry White Chemists Mirtazapine |
| Tablet 30 mg (orally disintegrating) | Oral | 30 | 5 | Avanza SolTab |
| Tablet 45 mg | Oral | 30 | 5 | Avanza Mirtazapine Sandoz Mirtazon |
| Tablet 45 mg (orally disintegrating) | Oral | 30 | 5 | Avanza SolTab |
Misoprostol | Tablet 200 micrograms | Oral | 120 | 2 | Cytotec |
Mitozantrone | Injection 10 mg (as hydrochloride) in 5 mL | Injection | 1 | .. | Mitozantrone Ebewe Pfizer Australia Pty Ltd |
| Injection 20 mg (as hydrochloride) in 10 mL | Injection | 1 | .. | Mitozantrone Ebewe |
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| Hospira Pty Limited |
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| Onkotrone |
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| Pfizer Australia Pty Ltd |
| Injection 25 mg (as hydrochloride) in 12.5 mL | Injection | 1 | .. | Onkotrone Pfizer Australia Pty Ltd |
Moclobemide | Tablet 150 mg | Oral | 60 | 5 | Amira 150 |
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| Aurorix |
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| Chem mart Moclobemide |
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| Clobemix |
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| GenRx Moclobemide |
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| Mohexal |
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| Terry White Chemists Moclobemide |
| Tablet 300 mg | Oral | 60 | 5 | Amira 300 |
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| Aurorix 300 mg |
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| Chem mart Moclobemide |
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| Clobemix |
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| GenRx Moclobemide |
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| Maosig |
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| Mohexal |
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| Terry White Chemists Moclobemide |
Modafinil | Tablet 100 mg | Oral | 120 | 5 | Modavigil |
Mometasone | Cream containing mometasone furoate 1 mg per g, 15 g | Application | 1 | .. | Elocon Novasone |
| Ointment containing mometasone furoate 1 mg per g, 15 g | Application | 1 | .. | Elocon Novasone |
| Lotion containing mometasone furoate 1 mg per g, 30 mL | Application | 1 | .. | Elocon Novasone |
Montelukast | Tablet, chewable, 4 mg (as sodium) | Oral | 28 | 5 | Singulair |
| Tablet, chewable, 5 mg (as sodium) | Oral | 28 | 5 | Singulair |
Morphine | Tablet containing morphine sulfate 10 mg | Oral | 20 | .. | Sevredol |
| Tablet containing morphine sulfate 20 mg | Oral | 20 | .. | Sevredol |
| Tablet containing morphine sulfate 30 mg | Oral | 20 | .. | Anamorph |
| Tablet containing morphine sulfate 5 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 10 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 15 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 30 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 60 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 100 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Tablet containing morphine sulfate 200 mg (controlled release) | Oral | 20 | .. | MS Contin |
| Capsule containing morphine sulfate 10 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 30 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 60 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Capsule containing morphine sulfate 90 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol |
| Capsule containing morphine sulfate 120 mg (controlled release) | Oral | 10 | .. | MS Mono |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet | Oral | 20 | .. | MS Contin Suspension 20 mg |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet | Oral | 20 | .. | MS Contin Suspension 30 mg |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet | Oral | 20 | .. | MS Contin Suspension 60 mg |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet | Oral | 20 | .. | MS Contin Suspension 100 mg |
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 200 mg per sachet | Oral | 20 | .. | MS Contin Suspension 200 mg |
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL | Oral | 1 | .. | Ordine 2 |
| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL | Oral | 1 | .. | Ordine 5 |
| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL | Oral | 1 | .. | Ordine 10 |
| Injection containing morphine sulfate 10 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited |
| Injection containing morphine tartrate 120 mg in 1.5 mL | Injection | 5 | .. | Hospira Pty Limited |
| Injection containing morphine sulfate 15 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited |
| Injection containing morphine sulfate 30 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited |
Moxonidine | Tablet 200 micrograms | Oral | 30 | 5 | Physiotens |
| Tablet 400 micrograms | Oral | 30 | 5 | Physiotens |
Mycophenolic Acid | Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid | Oral | 120 | 3 | Myfortic |
| Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid | Oral | 120 | 3 | Myfortic |
| Capsule containing mycophenolate mofetil 250 mg | Oral | 300 | 3 | CellCept |
| Tablet containing mycophenolate mofetil 500 mg | Oral | 150 | 3 | CellCept |
| Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL | Oral | 1 | 3 | CellCept |
Nafarelin | Nasal spray (pump pack) 200 micrograms (as acetate) per dose, 60 doses | Nasal | 1 | 5 | Synarel |
Naloxone | Injection containing naloxone hydrochloride 800 micrograms in 2 mL disposable injection set | Injection | 1 | .. | Naloxone Min‑I‑Jet |
| Injection containing naloxone hydrochloride 2 mg in 5 mL disposable injection set | Injection | 1 | .. | Naloxone Min‑I‑Jet |
Naltrexone | Tablet containing naltrexone hydrochloride 50 mg | Oral | 30 | 1 | Naltrexone QP ReVia |
Nandrolone Decanoate | Injection 50 mg in 1 mL disposable syringe | Injection | 1 | 7 | Deca‑Durabolin |
Naproxen | Tablet 250 mg | Oral | 100 | 3 | Inza 250 Naprosyn |
| Tablet containing naproxen sodium 550 mg | Oral | 50 | 3 | Anaprox 550 Crysanal |
| Tablet 500 mg | Oral | 50 | 3 | Inza 500 Naprosyn |
| Tablet 750 mg (sustained release) | Oral | 28 | 3 | Naprosyn SR750 Proxen SR 750 |
| Tablet 1 g (sustained release) | Oral | 28 | 3 | Naprosyn SR1000 Proxen SR 1000 |
| Oral suspension 125 mg per 5 mL, 474 mL | Oral | 1 | 3 | Naprosyn |
Naratriptan | Tablet 2.5 mg (as hydrochloride) | Oral | 4 | 5 | Naramig |
Nedocromil | Pressurised inhalation containing nedocromil sodium 2 mg per dose, 112 doses (CFC‑free formulation) | Inhalation by mouth | 1 | 5 | Tilade CFC‑Free |
Neomycin | Tablet containing neomycin sulfate 500 mg | Oral | 25 | 1 | Neosulf |
Neomycin with Bacitracin | Ear ointment 3.5 mg neomycin (as undecenoate) with bacitracin zinc 400 units per g, 10 g | Application to the ear | 1 | .. | Nemdyn |
Nicorandil | Tablets 10 mg, 60 | Oral | 1 | 5 | Ikorel |
| Tablets 20 mg, 60 | Oral | 1 | 5 | Ikorel |
Nifedipine | Tablet 10 mg | Oral | 60 | 5 | Adalat 10 Adefin 10 Nypine 10 |
| Tablet 20 mg | Oral | 60 | 5 | Adalat 20 |
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| Adefin 20 |
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| Chem mart Nifedipine |
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| GenRx Nifedipine |
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| Nifehexal |
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| Nyefax 20 mg |
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| Nypine 20 |
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| Terry White Chemists Nifedipine |
| Tablet 20 mg (controlled release) | Oral | 30 | 5 | Adalat Oros 20mg |
| Tablet 30 mg (controlled release) | Oral | 30 | 5 | Adalat Oros 30 Addos XR 30 Adefin XL 30 |
| Tablet 60 mg (controlled release) | Oral | 30 | 5 | Adalat Oros 60 Addos XR 60 Adefin XL 60 |
Nilutamide | Tablet 150 mg | Oral | 30 | 5 | Anandron |
Nitrazepam | Tablet 5 mg | Oral | 25 | .. | Alodorm Mogadon |
Nitrofurantoin | Capsule 50 mg | Oral | 30 | 1 | Macrodantin |
| Capsule 100 mg | Oral | 30 | 1 | Macrodantin |
Nizatidine | Capsule 150 mg | Oral | 60 | 5 | Nizac Tacidine Tazac |
| Capsule 300 mg | Oral | 30 | 5 | Nizac Tacidine Tazac |
Norethisterone | Tablets 350 micrograms, 28 | Oral | 4 | 2 | Locilan 28 Day Micronor Noriday 28 Day |
| Tablet 5 mg | Oral | 30 | 2 | Primolut N |
Norethisterone with Ethinyloestradiol | Tablets 500 micrograms‑35 micrograms, 21 | Oral | 4 | 2 | Brevinor |
| Pack containing 21 tablets 500 micrograms‑35 micrograms and 7 inert tablets | Oral | 4 | 2 | Brevinor Norimin 28 Day |
| Tablets 1 mg‑35 micrograms, 21 | Oral | 4 | 2 | Brevinor‑1 |
| Pack containing 21 tablets 1 mg‑35 micrograms and 7 inert tablets | Oral | 4 | 2 | Brevinor‑1 Norimin‑1 28 Day |
| Pack containing 12 tablets 500 micrograms‑35 micrograms, 9 tablets 1 mg‑35 micrograms and 7 inert tablets | Oral | 4 | 2 | Improvil 28 Day Synphasic |
Norethisterone with Mestranol | Tablets 1 mg‑50 micrograms, 21 | Oral | 4 | 2 | Norinyl‑1 |
| Pack containing 21 tablets 1 mg‑50 micrograms and 7 inert tablets | Oral | 4 | 2 | Norinyl‑1/28 |
Norfloxacin | Tablet 400 mg | Oral | 14 | 1 | Chem mart Norfloxacin |
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| GenRx Norfloxacin |
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| Genepharm Pty Ltd |
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| Norflohexal |
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| Noroxin |
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| Nufloxib |
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| Roxin |
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| Terry White Chemists Norfloxacin |
Nortriptyline | Tablet 10 mg (as hydrochloride) | Oral | 50 | 2 | Allegron |
| Tablet 25 mg (as hydrochloride) | Oral | 50 | 2 | Allegron |
Nystatin | Tablet 500,000 units | Oral | 50 | .. | Nilstat |
| Capsule 500,000 units | Oral | 50 | .. | Nilstat |
| Oral suspension 100,000 units per mL, 24 mL | Oral | 1 | 1 | Mycostatin Nilstat |
| Cream 100,000 units per g, 15 g | Application | 2 | 3 | Mycostatin |
Oestradiol | Tablet 2 mg | Oral | 56 | 2 | Zumenon |
| Tablet containing oestradiol valerate 1 mg | Oral | 56 | 2 | Progynova |
| Tablet containing oestradiol valerate 2 mg | Oral | 56 | 2 | Progynova |
| Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28 | Transdermal | 1 | 5 | Sandrena |
| Transdermal patches 390 micrograms, 8 | Transdermal | 1 | 5 | Estradot 25 |
| Transdermal patches 750 micrograms (as hemihydrate), 8 | Transdermal | 1 | 5 | Estraderm MX 25 |
| Transdermal patches 2 mg, 4 | Transdermal | 1 | 5 | Climara 25 |
| Transdermal patches 2 mg, 8 | Transdermal | 1 | 5 | Estraderm 25 |
| Transdermal patches 585 micrograms, 8 | Transdermal | 1 | 5 | Estradot 37.5 |
| Transdermal patches 1.5 mg (as hemihydrate), 8 | Transdermal | 1 | 5 | Estraderm MX 50 |
| Transdermal patches 3.8 mg, 4 | Transdermal | 1 | 5 | Climara 50 |
| Transdermal patches 4 mg, 8 | Transdermal | 1 | 5 | Estraderm 50 |
| Transdermal patches 780 micrograms, 8 | Transdermal | 1 | 5 | Estradot 50 |
| Transdermal patches 5.7 mg, 4 | Transdermal | 1 | 5 | Climara 75 |
| Transdermal patches 1.17 mg, | Transdermal | 1 | 5 | Estradot 75 |
| Transdermal patches 3 mg (as hemihydrate), 8 | Transdermal | 1 | 5 | Estraderm MX 100 |
| Transdermal patches 7.6 mg, 4 | Transdermal | 1 | 5 | Climara 100 |
| Transdermal patches 8 mg, 8 | Transdermal | 1 | 5 | Estraderm 100 |
| Transdermal patches 1.56 mg, 8 | Transdermal | 1 | 5 | Estradot 100 |
| Vaginal tablets 25 micrograms, 15 | Vaginal | 1 | 2 | Vagifem |
Oestradiol and Oestradiol with Dydrogesterone | Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg | Oral | 1 | 5 | Femoston 2/10 |
Oestradiol and Oestradiol with Norethisterone | Pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg | Oral | 1 | 5 | Trisequens |
| Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate | Transdermal | 1 | 5 | Estalis sequi 50/140 |
| Pack containing 4 transdermal patches 780 micrograms oestradiol (as hemihydrate) and 4 transdermal patches 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate | Transdermal | 1 | 5 | Estalis sequi 50/250 |
| Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg | Transdermal | 1 | 5 | Estracombi |
Oestradiol with Norethisterone | Tablets containing 1 mg oestradiol (as hemihydrate) with 500 micrograms norethisterone acetate, 28 | Oral | 1 | 5 | Kliovance |
| Tablets containing 2 mg oestradiol (as hemihydrate) with 1 mg norethisterone acetate, 28 | Oral | 1 | 5 | Kliogest |
| Transdermal patches containing 620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 | Transdermal | 1 | 5 | Estalis continuous 50/140 |
| Transdermal patches containing 510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 | Transdermal | 1 | 5 | Estalis continuous 50/250 |
Oestriol | Pessaries 500 micrograms, 15 | Vaginal | 1 | 2 | Ovestin Ovula |
| Vaginal cream 1 mg per g, 15 g | Application | 1 | 1 | Ovestin |
Oestrogens—Conjugated | Tablet 300 micrograms | Oral | 56 | 2 | Premarin |
| Tablet 625 micrograms | Oral | 56 | 2 | Premarin |
Oestrogens—Conjugated with Medroxyprogesterone | Tablets containing conjugated oestrogens 625 micrograms with medroxyprogesterone acetate 2.5 mg, 28 | Oral | 1 | 5 | Premia 2.5 Continuous |
| Tablets containing conjugated oestrogens 625 micrograms with medroxyprogesterone acetate 5 mg, 28 | Oral | 1 | 5 | Premia 5 Continuous |
Ofloxacin | Eye drops 3 mg per mL, 5 mL | Application to the eye | 2 | .. | Ocuflox |
Olanzapine | Tablet 2.5 mg | Oral | 28 | 5 | Zyprexa |
| Tablet 5 mg | Oral | 28 | 5 | Zyprexa |
| Tablet 7.5 mg | Oral | 28 | 5 | Zyprexa |
| Tablet 10 mg | Oral | 28 | 5 | Zyprexa |
| Wafer 5 mg | Oral | 28 | 5 | Zyprexa Zydis |
| Wafer 10 mg | Oral | 28 | 5 | Zyprexa Zydis |
Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Oral | 30 | 5 | Olmetec |
| Tablet containing olmesartan medoxomil 40 mg | Oral | 30 | 5 | Olmetec |
Olmesartan with Hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Olmetec Plus |
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg | Oral | 30 | 5 | Olmetec Plus |
| Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg | Oral | 30 | 5 | Olmetec Plus |
Olsalazine | Capsule containing olsalazine sodium 250 mg | Oral | 100 | 5 | Dipentum |
| Tablet containing olsalazine sodium 500 mg | Oral | 100 | 5 | Dipentum |
Omeprazole | Tablet 20 mg (as magnesium) | Oral | 30 | 1 | Acimax Tablets Losec Tablets Omepral |
| Tablet 20 mg | Oral | 30 | 1 | GenRx Omeprazole Meprazol Omeprazole‑GA Omeprazole Winthrop |
| Capsule 20 mg | Oral | 30 | 1 | Probitor |
| Tablet 10 mg (as magnesium) | Oral | 30 | 5 | Losec Tablets |
Omeprazole and Clarithromycin and Amoxycillin | Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) | Oral | 1 | .. | Klacid Hp 7 |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) | Oral | 4 | .. | Ondansetron‑RL |
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| Ondaz |
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| Onsetron 4 |
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| Zofran |
| Tablet 8 mg (as hydrochloride dihydrate) | Oral | 4 | .. | Ondansetron‑RL |
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| Ondaz |
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| Onsetron 8 |
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| Zofran |
| Wafer 4 mg | Oral | 4 | .. | Ondansetron‑RL Zydis Ondaz Zydis Zofran Zydis |
| Wafer 8 mg | Oral | 4 | .. | Ondansetron‑RL Zydis Ondaz Zydis Zofran Zydis |
| Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL | Oral | 1 | 1 | Zofran syrup 50 mL |
| I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL | Injection | 1 | .. | Ondansetron‑RL |
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| Ondaz |
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| Onsetron |
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| Pfizer Australia Pty Ltd |
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| Zofran |
| I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL | Injection | 1 | .. | Ondansetron‑RL |
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| Ondaz |
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| Onsetron |
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| Pfizer Australia Pty Ltd |
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| Zofran |
Oxaliplatin | Solution concentrate for I.V. infusion 50 mg in 10 mL | Injection | 1 | 2 | Eloxatin |
| Powder for I.V. infusion 50 mg | Injection | 1 | 2 | Hospira Pty Limited |
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| Oxalatin |
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| Oxaliplatin Ebewe |
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| Winthrop Oxaliplatin |
| Solution concentrate for I.V. infusion 100 mg in 20 mL | Injection | 1 | 2 | Eloxatin |
| Powder for I.V. infusion 100 mg | Injection | 1 | 2 | Hospira Pty Limited |
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| Oxalatin |
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| Oxaliplatin Ebewe |
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| Winthrop Oxaliplatin |
| Solution concentrate for I.V. infusion 200 mg in 40 mL | Injection | 1 | 2 | Eloxatin |
Oxazepam | Tablet 15 mg | Oral | 25 | .. | Alepam 15 Serepax |
| Tablet 30 mg | Oral | 25 | .. | Alepam 30 Murelax Serepax |
Oxcarbazepine | Tablet 150 mg | Oral | 100 | 5 | Trileptal |
| Tablet 300 mg | Oral | 100 | 5 | Trileptal |
| Tablet 600 mg | Oral | 100 | 5 | Trileptal |
| Oral suspension 60 mg per mL, 250 mL | Oral | 2 | 5 | Trileptal |
Oxprenolol | Tablet containing oxprenolol hydrochloride 20 mg | Oral | 100 | 5 | Corbeton 20 |
| Tablet containing oxprenolol hydrochloride 40 mg | Oral | 100 | 5 | Corbeton 40 |
Oxybutynin | Tablet containing oxybutynin hydrochloride 5 mg | Oral | 100 | 5 | Ditropan Oxybutynin Sandoz Oxybutynin Winthrop |
Oxycodone | Tablet containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | Endone |
| Capsule containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | OxyNorm |
| Capsule containing oxycodone hydrochloride 10 mg | Oral | 20 | .. | OxyNorm |
| Capsule containing oxycodone hydrochloride 20 mg | Oral | 20 | .. | OxyNorm |
| Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL | Oral | 1 | .. | OxyNorm Liquid 5mg/5mL |
| Tablet containing oxycodone hydrochloride 5 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 10 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 20 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 40 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Tablet containing oxycodone hydrochloride 80 mg (controlled release) | Oral | 20 | .. | OxyContin |
| Suppository 30 mg (as pectinate) | Rectal | 12 | .. | Proladone |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL vial | Injection | 5 | .. | Anzatax Paclitaxel Ebewe Taxol |
| Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial | Injection | 2 | .. | Anzatax Paclitaxel Ebewe Taxol |
| Solution concentrate for I.V. infusion 150 mg in 25 mL vial | Injection | 2 | .. | Anzatax Paclitaxel Ebewe Taxol |
| Solution concentrate for I.V. infusion 300 mg in 50 mL vial | Injection | 1 | .. | Anzatax Paclitaxel Ebewe Taxol |
Paliperidone | Tablet 3 mg (prolonged release) | Oral | 28 | 5 | Invega |
| Tablet 6 mg (prolonged release) | Oral | 28 | 5 | Invega |
| Tablet 9 mg (prolonged release | Oral | 28 | 5 | Invega |
Pamidronic Acid | Concentrated injection containing disodium pamidronate 15 mg in 5 mL | Injection | 4 | .. | Pamisol |
| Injection set containing 4 vials powder for I.V. infusion containing disodium pamidronate 15 mg and 4 ampoules solvent 5 mL | Injection | 1 | .. | Aredia 15 mg |
| Concentrated injection containing disodium pamidronate 30 mg in 10 mL | Injection | 2 | .. | Pamisol |
| Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL | Injection | 1 | .. | Aredia 30 mg |
| Concentrated injection containing disodium pamidronate 60 mg in 10 mL | Injection | 1 | .. | Pamisol |
Pancreatic Extract | Capsule (containing enteric coated minimicrospheres) providing not less than 5,000 BP units of lipase activity | Oral | 500 | 10 | Creon 5000 |
| Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity | Oral | 500 | 10 | Creon |
| Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity | Oral | 200 | 10 | Creon Forte |
Pancrelipase | Capsule (containing enteric coated microspheres) providing not less than 10,000 BP units of lipase activity | Oral | 500 | 10 | Cotazym‑S Forte |
| Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity | Oral | 200 | 10 | Panzytrat 25000 |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Oral | 30 | 2 | Somac |
| Tablet (enteric coated) 20 mg (as sodium sesquihydrate) | Oral | 30 | 5 | Somac |
Paracetamol | Tablet 500 mg | Oral | 100 | 1 | Chem mart Chemadol |
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| Dymadon P |
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| Febridol |
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| Panamax |
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| Paracetamol Sandoz |
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| Parahexal |
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| Paralgin |
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| Parmol |
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| Terry White Chemists Paracetamol |
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| Tylenol |
| Tablet 665 mg (modified release) | Oral | 192 | 5 | Panadol Osteo |
| Oral liquid 120 mg per 5 mL, 100 mL | Oral | 1 | 2 | Panamax |
| Oral liquid 240 mg per 5 mL, 200 mL | Oral | 1 | 2 | Panamax 240 Elixir |
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Application to the eye | 2 | 5 | Duratears Poly Visc |
| Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Application to the eye | 1 | 5 | Ircal Lacri‑Lube Poly Visc |
Paroxetine | Tablet 20 mg (as hydrochloride) | Oral | 30 | 5 | Aropax |
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| Chem mart Paroxetine |
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| Extine 20 |
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| GenRx Paroxetine |
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| Paroxetine 20 |
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| Paroxetine‑DP |
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| Paroxetine Sandoz |
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| Paroxetine Winthrop |
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| Paxtine |
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| Terry White Chemists Paroxetine |
Pemetrexed | Powder for I.V. infusion 100 mg (as disodium heptahydrate) | Injection | 1 | 3 | Alimta |
| Powder for I.V. infusion 500 mg (as disodium heptahydrate) | Injection | 1 | 3 | Alimta |
Penicillamine | Tablet 125 mg | Oral | 100 | 1 | D‑Penamine |
| Tablet 250 mg | Oral | 100 | 1 | D‑Penamine |
Pergolide | Tablet 50 micrograms (as mesylate) | Oral | 100 | .. | Permax |
| Tablet 250 micrograms (as mesylate) | Oral | 100 | 5 | Permax |
| Tablet 1 mg (as mesylate) | Oral | 100 | 5 | Permax |
Perhexiline | Tablet containing perhexiline maleate 100 mg | Oral | 100 | 5 | Pexsig |
Pericyazine | Tablet 2.5 mg | Oral | 100 | 5 | Neulactil |
| Tablet 10 mg | Oral | 100 | 5 | Neulactil |
Perindopril | Tablet containing perindopril erbumine 2 mg | Oral | 30 | 5 | Chem mart Perindopril |
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| GenRx Perindopril |
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| Indopril 2 |
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| Perindo |
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| Perindopril 2 |
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| Perindopril‑DP |
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| Terry White Chemists Perindopril |
| Tablet containing perindopril arginine 2.5 mg | Oral | 30 | 5 | Coversyl 2.5mg |
| Tablet containing perindopril erbumine 4 mg | Oral | 30 | 5 | Chem mart Perindopril |
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| GenRx Perindopril |
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| Indopril 4 |
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| Perindo |
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| Perindopril 4 |
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| Perindopril‑DP |
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| Terry White Chemists Perindopril |
| Tablet containing perindopril arginine 5 mg | Oral | 30 | 5 | Coversyl 5mg |
| Tablet containing perindopril erbumine 8 mg | Oral | 30 | 5 | Chem mart Perindopril |
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| GenRx Perindopril |
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| Indopril 8 |
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| Perindo |
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| Perindopril 8 |
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| Perindopril‑DP |
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| Terry White Chemists Perindopril |
| Tablet containing perindopril arginine 10 mg | Oral | 30 | 5 | Coversyl 10mg |
Perindopril with Indapamide | Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg | Oral | 30 | 5 | Coversyl Plus LD 2.5mg/0.625mg |
| Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg | Oral | 30 | 5 | Chem mart Perindopril/ Indapamide 4/1.25 |
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| GenRx Perindopril/ Indapamide 4/1.25 |
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| Perindo Combi 4/1.25 |
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| Terry White Chemists Perindopril/ Indapamide 4/1.25 |
| Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg | Oral | 30 | 5 | Coversyl Plus 5mg/1.25mg |
Permethrin | Cream 50 mg per g, 30 g | Application | 1 | 1 | Lyclear |
Phenelzine | Tablet 15 mg (as sulfate) | Oral | 100 | 1 | Nardil |
Phenobarbitone | Tablet 30 mg | Oral | 200 | 4 | Sigma Pharmaceuticals (Australia) Pty Ltd |
| Injection containing phenobarbitone sodium 200 mg in 1 mL | Injection | 5 | .. | Fawns and McAllan Proprietary Limited |
Phenoxybenzamine | Capsule containing phenoxybenzamine hydrochloride 10 mg | Oral | 100 | 5 | Dibenyline |
| Capsules containing phenoxybenzamine hydrochloride 10 mg, 30 | Oral | 3 | 5 | Dibenyline |
Phenoxymethylpenicillin | Tablet 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin‑VK Filmtab |
| Tablet 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin‑VK Filmtab |
| Capsule 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK |
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| Cilopen VK |
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| LPV |
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| Penhexal VK |
| Capsule 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK |
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| Cilopen VK |
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| LPV |
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| Penhexal VK |
| Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | 2 | 1 | Abbocillin‑V Cilicaine V |
Phenytoin | Tablet 50 mg | Oral | 200 | 2 | Dilantin Infatabs |
| Capsule containing phenytoin sodium 30 mg | Oral | 200 | 2 | Dilantin Sodium |
| Capsule containing phenytoin sodium 100 mg | Oral | 200 | 2 | Dilantin Sodium |
| Oral suspension 30 mg per 5 mL, 500 mL | Oral | 1 | 3 | Dilantin |
Pilocarpine | Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL | Application to the eye | 1 | 5 | Isopto Carpine P.V. Carpine Pilopt |
| Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL | Application to the eye | 1 | 5 | Isopto Carpine P.V. Carpine Pilopt |
| Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL | Application to the eye | 1 | 5 | Isopto Carpine P.V. Carpine Pilopt |
| Eye drops containing pilocarpine hydrochloride 60 mg per mL, 15 mL | Application to the eye | 1 | 5 | P.V. Carpine Pilopt |
Pimecrolimus | Cream 10 mg per g, 15 g | Application | 1 | 1 | Elidel |
Pindolol | Tablet 5 mg | Oral | 100 | 5 | Barbloc 5 Visken 5 |
| Tablet 15 mg | Oral | 50 | 5 | Barbloc 15 Visken 15 |
Pioglitazone | Tablet 15 mg (as hydrochloride) | Oral | 28 | 5 | Actos |
| Tablet 30 mg (as hydrochloride) | Oral | 28 | 5 | Actos |
| Tablet 45 mg (as hydrochloride) | Oral | 28 | 5 | Actos |
Piperazine Oestrone | Tablet 730 micrograms (as sulfate) | Oral | 56 | 2 | Genoral 0.625 Ogen .625 |
| Tablet 1.46 mg (as sulfate) | Oral | 56 | 2 | Genoral 1.25 Ogen 1.25 |
Piroxicam | Dispersible tablet 10 mg | Oral | 50 | 3 | Feldene‑D GenRx Piroxicam Dispersible Mobilis D‑10 |
| Dispersible tablet 20 mg | Oral | 25 | 3 | Chem mart Piroxicam Dispersible |
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| Feldene‑D |
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| GenRx Piroxicam Dispersible |
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| Mobilis D‑20 |
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| Terry White Chemists Piroxicam Dispersible |
| Capsule 10 mg | Oral | 50 | 3 | Chem mart Piroxicam |
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| Feldene |
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| GenRx Piroxicam |
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| Mobilis 10 |
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| Terry White Chemists Piroxicam |
| Capsule 20 mg | Oral | 25 | 3 | Chem mart Piroxicam |
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| Feldene |
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| GenRx Piroxicam |
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| Mobilis 20 |
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| Terry White Chemists Piroxicam |
Pizotifen | Tablet 500 micrograms (as malate) | Oral | 100 | 2 | Sandomigran 0.5 |
Pneumococcal Vaccine ‑ Polyvalent | Injection 0.5 mL (23 valent) | Injection | 1 | .. | Pneumovax 23 |
Polyethylene Glycol 400 with Propylene Glycol | Eye drops 4 mg‑3 mg per mL, 15 mL | Application to the eye | 1 | 5 | Systane |
Polygeline | I.V. infusion 17.5 g per 500 mL with electrolytes, 500 mL | Injection | 3 | .. | Haemaccel |
Polyvinyl Alcohol | Eye drops 14 mg per mL, 15 mL | Application to the eye | 1 | 5 | Liquifilm Tears PVA Tears |
| Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) | Application to the eye | 1 | 5 | Vistil |
| Eye drops 30 mg per mL, 15 mL | Application to the eye | 1 | 5 | Liquifilm Forte PVA Forte |
| Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) | Application to the eye | 1 | 5 | Vistil Forte |
Potassium Chloride | Tablet 600 mg (sustained release) | Oral | 200 | 1 | Duro‑K Slow‑K Span‑K |
Potassium Chloride with Potassium Bicarbonate | Tablet, effervescent, 14 mmol potassium and 8 mmol chloride | Oral | 60 | 1 | Chlorvescent K‑Sol |
Pramipexole | Tablet containing pramipexole hydrochloride 125 micrograms | Oral | 30 | .. | Sifrol |
| Tablet containing pramipexole hydrochloride 250 micrograms | Oral | 100 | 5 | Sifrol |
| Tablet containing pramipexole hydrochloride 1 mg | Oral | 100 | 5 | Sifrol |
Pravastatin | Tablet containing pravastatin sodium 10 mg | Oral | 30 | 5 | Chem mart Pravastatin |
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| Cholstat 10 |
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| GenRx Pravastatin |
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| Lipostat 10 |
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| Liprachol |
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| Pravachol |
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| Pravastatin 10 |
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| Pravastatin‑DP |
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| Pravastatin Winthrop |
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| Terry White Chemists Pravastatin |
| Tablet containing pravastatin sodium 20 mg | Oral | 30 | 5 | Chem mart Pravastatin |
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| Cholstat 20 |
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| GenRx Pravastatin |
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| Lipostat 20 |
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| Liprachol |
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| Pravachol |
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| Pravastatin 20 |
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| Pravastatin‑DP |
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| Pravastatin Winthrop |
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| Terry White Chemists Pravastatin |
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| Vastoran |
| Tablet containing pravastatin sodium 40 mg | Oral | 30 | 5 | Chem mart Pravastatin |
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| Cholstat 40 |
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| GenRx Pravastatin |
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| Lipostat 40 |
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| Liprachol |
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| Pravachol |
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| Pravastatin 40 |
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| Pravastatin‑DP |
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| Pravastatin Winthrop |
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| Terry White Chemists Pravastatin |
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| Vastoran |
| Tablet containing pravastatin sodium 80 mg | Oral | 30 | 5 | Lipostat 80 Pravachol |
Prazosin | Tablet 1 mg (as hydrochloride) | Oral | 100 | 5 | Chem mart Prazosin |
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| GenRx Prazosin |
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| Minipress |
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| Pressin 1 |
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| Terry White Chemists Prazosin |
| Tablet 2 mg (as hydrochloride) | Oral | 100 | 5 | Chem mart Prazosin |
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| GenRx Prazosin |
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| Minipress |
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| Pressin 2 |
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| Terry White Chemists Prazosin |
| Tablet 5 mg (as hydrochloride) | Oral | 100 | 5 | Chem mart Prazosin |
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| GenRx Prazosin |
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| Minipress |
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| Pressin 5 |
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| Terry White Chemists Prazosin |
Prednisolone | Tablet 1 mg | Oral | 100 | 4 | Panafcortelone Predsolone |
| Tablet 5 mg | Oral | 60 | 4 | Panafcortelone Solone |
| Tablet 25 mg | Oral | 30 | 4 | Panafcortelone Solone |
| Oral solution 5 mg (as sodium phosphate) per mL, 30 mL | Oral | 1 | 5 | PredMix Redipred |
| Enema, retention, 20 mg (as sodium phosphate) in 100 mL | Rectal | 28 | 3 | Predsol |
| Suppositories 5 mg (as sodium phosphate), 10 | Rectal | 3 | 3 | Predsol |
Prednisolone with Phenylephrine | Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL | Application to the eye | 1 | 2 | Prednefrin Forte |
Prednisone | Tablet 1 mg | Oral | 100 | 4 | Panafcort Predsone |
| Tablet 5 mg | Oral | 60 | 4 | Panafcort Sone |
| Tablet 25 mg | Oral | 30 | 4 | Panafcort Sone |
Primidone | Tablet 250 mg | Oral | 200 | 2 | Mysoline |
Probenecid | Tablet 500 mg | Oral | 100 | 5 | Pro‑Cid |
Procaine Penicillin | Injection 1.5 g in disposable syringe | Injection | 5 | .. | Cilicaine |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Oral | 25 | .. | Stemetil Stemzine |
| Injection containing prochlorperazine mesylate 12.5 mg in 1 mL | Injection | 10 | .. | Stemetil |
| Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 | Rectal | 1 | 2 | Stemetil |
Promethazine | Injection containing promethazine hydrochloride 50 mg in 2 mL | Injection | 10 | .. | Hospira Pty Limited |
Propantheline | Tablet containing propantheline bromide 15 mg | Oral | 200 | 5 | Pro‑Banthine |
Propranolol | Tablet containing propranolol hydrochloride 10 mg | Oral | 100 | 5 | Deralin 10 Inderal |
| Tablet containing propranolol hydrochloride 40 mg | Oral | 100 | 5 | Deralin 40 Inderal |
| Tablet containing propranolol hydrochloride 160 mg | Oral | 50 | 5 | Deralin 160 |
Propylthiouracil | Tablet 50 mg | Oral | 200 | 2 | Virgo Unit Trust |
Protein hydrolysate formula with medium chain triglycerides | Oral powder 400 g (Alfaré) | Oral | 8 | 5 | Alfaré |
| Oral powder 450 g (Pepti‑Junior) | Oral | 8 | 5 | Pepti‑Junior |
Pyrantel | Tablet 125 mg (as embonate) | Oral | 6 | .. | Anthel 125 |
| Tablet 250 mg (as embonate) | Oral | 6 | .. | Anthel 250 |
Pyridostigmine | Tablet containing pyridostigmine bromide 10 mg | Oral | 100 | 5 | Mestinon |
| Tablet containing pyridostigmine bromide 60 mg | Oral | 150 | 5 | Mestinon |
| Tablet containing pyridostigmine bromide 180 mg (modified release) | Oral | 100 | 5 | Mestinon Timespan |
Pyrimethamine | Tablet 25 mg | Oral | 50 | .. | Daraprim |
Quetiapine | Tablet 25 mg (as fumarate) | Oral | 60 | 5 | Seroquel |
| Tablet 100 mg (as fumarate) | Oral | 90 | 5 | Seroquel |
| Tablet 200 mg (as fumarate) | Oral | 60 | 5 | Seroquel |
| Tablet 300 mg (as fumarate) | Oral | 60 | 5 | Seroquel |
Quinagolide | Pack containing 3 tablets quinagolide 25 micrograms (as hydrochloride) and 3 tablets quinagolide 50 micrograms (as hydrochloride) | Oral | 1 | .. | Norprolac |
| Tablet 75 micrograms (as hydrochloride) | Oral | 30 | 5 | Norprolac |
Quinapril | Tablet 5 mg (as hydrochloride) | Oral | 30 | 5 | Accupril Acquin 5 APO‑Quinapril Filpril Pharmacor Quinapril 5 Quinapril‑DP |
| Tablet 10 mg (as hydrochloride) | Oral | 30 | 5 | Accupril Acquin 10 APO‑Quinapril Filpril Pharmacor Quinapril 10 Quinapril‑DP |
| Tablet 20 mg (as hydrochloride) | Oral | 30 | 5 | Accupril Acquin 20 APO‑Quinapril Filpril Pharmacor Quinapril 20 Quinapril‑DP Quinapril Sandoz |
Quinapril with Hydrochlorothiazide | Tablet 10 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide | Oral | 30 | 5 | Accuretic 10/12.5mg |
| Tablet 20 mg quinapril (as hydrochloride) with 12.5 mg hydrochlorothiazide | Oral | 30 | 5 | Accuretic 20/12.5mg |
Quinine | Tablet containing quinine bisulfate 300 mg | Oral | 50 | 2 | Quinbisul |
| Tablet containing quinine sulfate 300 mg | Oral | 50 | 2 | Quinate Quinsul |
Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) | Oral | 30 | 2 | Pariet |
| Tablet containing rabeprazole sodium 10 mg (enteric coated) | Oral | 28 | 5 | Pariet |
Raloxifene | Tablet containing raloxifene hydrochloride 60 mg | Oral | 28 | 5 | Evista |
Raltitrexed | Powder for I.V. infusion 2 mg in single use vial | Injection | 3 | 2 | Tomudex |
Ramipril | Tablet 1.25 mg | Oral | 30 | 5 | Prilace 1.25 |
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| Ramace 1.25 mg |
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| Ramipril Sandoz |
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| Ramipril Winthrop |
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| Tritace 1.25 mg |
| Capsule 1.25 mg | Oral | 30 | 5 | Tryzan 1.25 |
| Tablet 2.5 mg | Oral | 30 | 5 | Prilace 2.5 |
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| Ramace 2.5 mg |
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| Ramipril Sandoz |
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| Ramipril Winthrop |
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| Tritace 2.5 mg |
| Capsule 2.5 mg | Oral | 30 | 5 | Tryzan 2.5 |
| Tablet 5 mg | Oral | 30 | 5 | Prilace 5 |
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| Ramace 5 mg |
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| Ramipril Sandoz |
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| Ramipril Winthrop |
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| Tritace 5 mg |
| Capsule 5 mg | Oral | 30 | 5 | Tryzan 5 |
| Tablet 10 mg | Oral | 30 | 5 | Tritace |
| Capsule 10 mg | Oral | 30 | 5 | Prilace 10 |
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| Ramace 10 mg |
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| Ramipril Sandoz |
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| Ramipril Winthrop |
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| Tritace 10 mg |
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| Tryzan 10 |
| Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg | Oral | 1 | .. | Tritace Titration Pack |
Ramipril with Felodipine | Tablet 2.5 mg‑2.5 mg (modified release) | Oral | 30 | 5 | Triasyn 2.5/2.5 |
| Tablet 5 mg‑5 mg (modified release) | Oral | 30 | 5 | Triasyn 5.0/5.0 |
Ranibizumab | Solution for intravitreal injection 3 mg in 0.3 mL | Injection | 1 | 2 | Lucentis |
Ranitidine | Tablet 150 mg (as hydrochloride) | Oral | 60 | 5 | Ausran |
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| Chem mart Ranitidine |
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| GenRx Ranitidine |
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| Rani 2 |
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| Ranihexal |
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| Ranoxyl |
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| Terry White Chemists Ranitidine |
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| Ulcaid |
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| Zantac |
| Tablet, effervescent, 150 mg (as hydrochloride) | Oral | 60 | 5 | Zantac |
| Tablet 300 mg (as hydrochloride) | Oral | 30 | 5 | Ausran |
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| Chem mart Ranitidine |
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| GenRx Ranitidine |
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| Rani 2 |
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| Ranihexal |
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| Ranoxyl |
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| Terry White Chemists Ranitidine |
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| Ulcaid |
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| Zantac |
| Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL | Oral | 2 | 5 | Zantac Syrup |
Reboxetine | Tablet 4 mg (as mesilate) | Oral | 60 | 5 | Edronax |
Reteplase | Pack containing 2 vials powder for injection 10 units, 2 single use pre‑filled syringes with solvent, 2 reconstitution spikes and 2 needles | Injection | 1 | .. | Rapilysin 10 U |
Rifampicin | Capsule 150 mg | Oral | 10 | .. | Rimycin 150 |
| Capsule 300 mg | Oral | 10 | .. | Rimycin 300 |
| Syrup 100 mg per 5 mL, 60 mL | Oral | 1 | .. | Rifadin |
Riluzole | Tablet 50 mg | Oral | 56 | 5 | Rilutek |
Risedronic Acid | Tablet containing risedronate sodium 5 mg | Oral | 28 | 5 | Actonel |
| Tablet containing risedronate sodium 35 mg | Oral | 4 | 5 | Actonel Once‑a‑Week |
| Tablet containing risedronate sodium 30 mg | Oral | 28 | 1 | Actonel |
Risedronic Acid and Calcium | Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate) | Oral | 1 | 5 | Actonel Combi |
Risedronic acid and calcium with colecalciferol | Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms | Oral | 1 | 5 | Actonel Combi D |
Risperidone | Tablet 0.5 mg | Oral | 60 | 2 | Risperdal |
| Tablet 0.5 mg (orally disintegrating) | Oral | 56 | 2 | Risperdal Quicklet |
| Tablet 1 mg | Oral | 60 | 2 | Risperdal |
| Tablet 1 mg (orally disintegrating) | Oral | 56 | 2 | Risperdal Quicklet |
| Tablet 2 mg | Oral | 60 | 2 | Risperdal |
| Tablet 2 mg (orally disintegrating) | Oral | 56 | 2 | Risperdal Quicklet |
| Tablet 3 mg | Oral | 60 | 5 | Risperdal |
| Tablet 3 mg (orally disintegrating) | Oral | 56 | 5 | Risperdal Quicklet |
| Tablet 4 mg | Oral | 60 | 5 | Risperdal |
| Tablet 4 mg (orally disintegrating) | Oral | 56 | 5 | Risperdal Quicklet |
| Oral solution 1 mg per mL, 30 mL | Oral | 1 | 2 | Risperdal |
| Oral solution 1 mg per mL, 100 mL | Oral | 1 | 5 | Risperdal |
| I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre‑filled syringe diluent 2 mL | Injection | 2 | 5 | Risperdal Consta |
| I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre‑filled syringe diluent 2 mL | Injection | 2 | 5 | Risperdal Consta |
| I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre‑filled syringe diluent 2 mL | Injection | 2 | 5 | Risperdal Consta |
Rituximab | Solution for I.V. infusion 100 mg in 10 mL | Injection | 2 | 3 | Mabthera |
| Solution for I.V. infusion 500 mg in 50 mL | Injection | 1 | 3 | Mabthera |
Rivastigmine | Capsule 1.5 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon |
| Capsule 3 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon |
| Capsule 4.5 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon |
| Capsule 6 mg (as hydrogen tartrate) | Oral | 56 | 5 | Exelon |
| Oral solution 2 mg (as hydrogen tartrate) per mL, 120 mL | Oral | 1 | 5 | Exelon |
| Transdermal patch 9 mg | Transdermal | 30 | 5 | Exelon Patch 5 |
| Transdermal patch 18 mg | Transdermal | 30 | 5 | Exelon Patch 10 |
Rosiglitazone | Tablet 4 mg (as maleate) | Oral | 28 | 5 | Avandia |
| Tablet 8 mg (as maleate) | Oral | 28 | 5 | Avandia |
Rosiglitazone with Metformin | Tablet 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride | Oral | 56 | 5 | Avandamet |
| Tablet 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride | Oral | 56 | 5 | Avandamet |
| Tablet 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride | Oral | 56 | 5 | Avandamet |
| Tablet 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride | Oral | 56 | 5 | Avandamet |
Rosuvastatin | Tablet 5 mg (as calcium) | Oral | 30 | 5 | Crestor |
| Tablet 10 mg (as calcium) | Oral | 30 | 5 | Crestor |
| Tablet 20 mg (as calcium) | Oral | 30 | 5 | Crestor |
| Tablet 40 mg (as calcium) | Oral | 30 | 5 | Crestor |
Roxithromycin | Tablet for oral suspension 50 mg | Oral | 10 | 1 | Rulide D |
| Tablet 150 mg | Oral | 10 | 1 | Biaxsig |
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| Roxar 150 |
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| Roxide |
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| Roximycin |
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| Rulide |
| Tablet 300 mg | Oral | 5 | 1 | Biaxsig |
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| Roxar 300 |
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| Roxide |
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| Roximycin |
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| Rulide |
Salbutamol | Oral solution 2 mg (as sulfate) per 5 mL, 150 mL | Oral | 2 | 5 | Ventolin |
| Capsule containing powder for oral inhalation 200 micrograms (as sulfate) (for use in Ventolin Rotahaler) | Inhalation by mouth | 200 | 5 | Ventolin Rotacaps |
| Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 2 | 5 | Airomir |
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| Asmol CFC‑free |
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| Epaq |
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| Ventolin CFC‑free |
| Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC‑free formulation) | Inhalation by mouth | 2 | 5 | Airomir Autohaler |
| Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | 2 | 5 | Asmol 2.5 uni‑dose |
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| Butamol 2.5 |
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| Chem mart Salbutamol |
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| GenRx Salbutamol |
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| Pfizer Australia Pty Ltd |
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| Pharmacor Salbutamol 2.5 |
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| Salbutamol‑GA |
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| Salbutamol Sandoz |
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| Terry White Chemists Salbutamol |
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| Ventolin Nebules |
| Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | 2 | 5 | Asmol 5 uni‑dose |
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| Butamol 5 |
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| Chem mart Salbutamol |
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| GenRx Salbutamol |
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| Pharmacor Salbutamol 5 |
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| Salbutamol‑GA |
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| Salbutamol Sandoz |
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| Terry White Chemists Salbutamol |
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| Ventolin Nebules |
| Nebuliser solution 5 mg (as sulfate) per mL, 30 mL | Inhalation | 2 | 2 | Pfizer Australia Pty Ltd |
Salcatonin | Injection 50 I.U. in 1 mL ampoule | Injection | 30 | 5 | Miacalcic 50 |
| Injection 100 I.U. in 1 mL ampoule | Injection | 15 | 5 | Miacalcic 100 |
Salmeterol | Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses | Inhalation by mouth | 1 | 5 | Serevent Accuhaler |
Selegiline | Tablet containing selegiline hydrochloride 5 mg | Oral | 100 | 5 | Eldepryl Selgene |
Sertraline | Tablet 50 mg (as hydrochloride) | Oral | 30 | 5 | Chem mart Sertraline |
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| Concorz |
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| Eleva 50 |
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| GenRx Sertraline |
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| Sertra 50 |
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| Sertraline 50 |
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| Sertraline‑DP |
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| Sertraline generichealth |
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| Sertraline Winthrop |
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| Setrona |
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| Terry White Chemists Sertraline |
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| Xydep 50 |
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| Zoloft |
| Tablet 100 mg (as hydrochloride) | Oral | 30 | 5 | Chem mart Sertraline |
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| Concorz |
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| Eleva 100 |
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| GenRx Sertraline |
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| Sertra 100 |
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| Sertraline 100 |
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| Sertraline‑DP |
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| Sertraline generichealth |
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| Sertraline Winthrop |
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| Setrona |
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| Terry White Chemists Sertraline |
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| Xydep 100 |
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| Zoloft |
Sevelamer | Tablet containing sevelamer hydrochloride 800 mg | Oral | 180 | 5 | Renagel |
Silver Sulfadiazine with Chlorhexidine | Cream containing silver sulfadiazine 10 mg with chlorhexidine gluconate 2 mg per g, 50 g | Application | 1 | .. | Silvazine |
| Cream containing silver sulfadiazine 10 mg with chlorhexidine gluconate 2 mg per g, 100 g | Application | 1 | .. | Silvazine |
Simvastatin | Tablet 5 mg | Oral | 30 | 5 | Simvabell |
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| Simvahexal |
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| Simvasyn |
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| Zimstat |
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| Zocor |
| Tablet 10 mg | Oral | 30 | 5 | Chem mart Simvastatin |
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| GenRx Simvastatin |
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| Genepharm Pty Ltd |
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| Lipex 10 |
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| Ransim |
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| Simvabell |
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| Simvahexal |
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| Simvar 10 |
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| Simvastatin‑DP |
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| Simvastatin generichealth |
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| Simvastatin Winthrop |
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| Simvasyn |
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| Terry White Chemists Simvastatin |
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| Zimstat |
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| Zocor |
| Tablet 20 mg | Oral | 30 | 5 | Chem mart Simvastatin |
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| GenRx Simvastatin |
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| Genepharm Pty Ltd |
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| Lipex 20 |
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| Ransim |
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| Simvabell |
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| Simvahexal |
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| Simvar 20 |
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| Simvastatin‑DP |
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| Simvastatin generichealth |
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| Simvastatin Winthrop |
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| Simvasyn |
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| Terry White Chemists Simvastatin |
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| Zimstat |
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| Zocor |
| Tablet 40 mg | Oral | 30 | 5 | Chem mart Simvastatin |
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| GenRx Simvastatin |
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| Genepharm Pty Ltd |
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| Lipex 40 |
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| Ransim |
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| Simvabell |
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| Simvahexal |
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| Simvar 40 |
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| Simvastatin‑DP |
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| Simvastatin generichealth |
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| Simvastatin Winthrop |
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| Simvasyn |
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| Terry White Chemists Simvastatin |
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| Zimstat |
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| Zocor |
| Tablet 80 mg | Oral | 30 | 5 | Chem mart Simvastatin |
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| GenRx Simvastatin |
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| Genepharm Pty Ltd |
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| Lipex 80 |
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| Ransim |
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| Simvabell |
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| Simvahexal |
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| Simvar 80 |
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| Simvastatin‑DP |
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| Simvastatin generichealth |
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| Simvastatin Winthrop |
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| Simvasyn |
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| Terry White Chemists Simvastatin |
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| Zimstat |
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| Zocor |
Sirolimus | Tablet 1 mg | Oral | 100 | 3 | Rapamune |
| Tablet 2 mg | Oral | 100 | 3 | Rapamune |
| Oral solution 1 mg per mL, 60 mL | Oral | 1 | 3 | Rapamune |
Sodium Acid Phosphate | Tablet, compound effervescent, equivalent to 500 mg phosphorus | Oral | 100 | 5 | Phosphate Sandoz |
Sodium Chloride | Injection 9 mg per mL, 10 mL | Injection | 5 | 1 | Pfizer Australia Pty Ltd |
| I.V. infusion 154 mmol per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Limited |
| I.V. infusion 513 mmol per L, 1 L | Injection | 2 | 1 | Baxter Healthcare Pty Limited |
Sodium Chloride Compound | I.V. infusion containing approximately 148 mmol sodium (as chloride), 4 mmol potassium (as chloride), 2 mmol calcium (as chloride) and 156 mmol chloride per L, 1 L | Injection | 4 | 1 | Baxter Healthcare Pty Limited |
Sodium Chloride with Glucose | I.V. infusion 31 mmol‑222 mmol (anhydrous) per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Limited |
| I.V. infusion 19 mmol‑104 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | 1 | Baxter Healthcare Pty Limited |
| I.V. infusion 39 mmol‑69 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | 1 | Baxter Healthcare Pty Limited |
Sodium Lactate Compound | I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L | Injection | 5 | 1 | Baxter Healthcare Pty Limited |
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | Enemas 3.125 g‑450 mg‑45 mg in 5 mL, 12 | Rectal | 2 | 2 | Microlax |
Sotalol | Tablet containing sotalol hydrochloride 80 mg | Oral | 60 | 5 | GenRx Sotalol |
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| Solavert |
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| Sotacor |
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| Sotahexal |
| Tablet containing sotalol hydrochloride 160 mg | Oral | 60 | 5 | Cardol |
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| Chem mart Sotalol |
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| GenRx Sotalol |
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| Solavert |
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| Sotab |
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| Sotacor |
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| Sotahexal |
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| Terry White Chemists Sotalol |
Soy protein and fat formula with vitamins and minerals — carbohydrate free | Oral liquid 384 mL (RCF) | Oral | 120 | 5 | RCF |
Spironolactone | Tablet 25 mg | Oral | 100 | 5 | Aldactone Spiractin 25 |
| Tablet 100 mg | Oral | 100 | 5 | Aldactone Spiractin 100 |
Sterculia with Frangula Bark | Granules 620 mg‑80 mg per g, 500 g | Oral | 1 | 1 | Normacol Plus |
Strontium | Sachet containing granules for oral suspension containing strontium ranelate 2 g | Oral | 28 | 5 | Protos 2 g |
Sucralfate | Tablet equivalent to 1 g anhydrous sucralfate | Oral | 120 | 2 | Carafate Ulcyte |
Sulfacetamide | Eye drops containing sulfacetamide sodium 100 mg per mL, 15 mL | Application to the eye | 1 | 2 | Bleph 10 |
Sulfasalazine | Tablet 500 mg | Oral | 200 | 5 | Salazopyrin |
| Tablet 500 mg (enteric coated) | Oral | 200 | 5 | Pyralin EN Salazopyrin‑EN |
Sulindac | Tablet 100 mg | Oral | 100 | 3 | Aclin |
| Tablet 200 mg | Oral | 50 | 3 | Aclin 200 |
Sulthiame | Tablet 50 mg | Oral | 200 | 2 | Ospolot |
| Tablet 200 mg | Oral | 200 | 2 | Ospolot |
Sumatriptan | Tablet 50 mg (as succinate) | Oral | 4 | 5 | Imigran Sumagran 50 Sumatab Suvalan 50 |
| Tablet (fast disintegrating) 50 mg (as succinate) | Oral | 4 | 5 | Imigran FDT |
| Nasal spray 20 mg in 0.1 mL single dose unit | Nasal | 2 | 5 | Imigran |
Tacrolimus | Capsule 500 micrograms | Oral | 100 | 3 | Prograf |
| Capsule 1 mg | Oral | 100 | 3 | Prograf |
| Capsule 5 mg | Oral | 50 | 3 | Prograf |
Tamarindus indica seed polysaccharide | Eye drops 10 mg per mL, 0.5 mL, 20 | Application to the eye | 3 | 5 | Visine Professional |
Tamoxifen | Tablet 10 mg (as citrate) | Oral | 60 | 5 | Genox 10 Nolvadex Tamoxen 10 mg |
| Tablet 20 mg (as citrate) | Oral | 60 | 5 | Chem mart Tamoxifen |
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| Genox 20 |
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| GenRx Tamoxifen |
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| Nolvadex‑D |
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| Tamosin |
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| Tamoxen 20 mg |
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| Tamoxifen Sandoz |
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| Terry White Chemists Tamoxifen |
Telmisartan | Tablet 40 mg | Oral | 28 | 5 | Micardis |
| Tablet 80 mg | Oral | 28 | 5 | Micardis |
Telmisartan with Hydrochlorothiazide | Tablet 40 mg‑12.5 mg | Oral | 28 | 5 | Micardis Plus 40/12.5 mg |
| Tablet 80 mg‑12.5 mg | Oral | 28 | 5 | Micardis Plus 80/12.5 mg |
Temazepam | Tablet 10 mg | Oral | 25 | .. | Normison Temaze Temtabs |
Temozolomide | Capsule 5 mg | Oral | 15 | 2 | Temodal |
| Capsule 20 mg | Oral | 15 | 2 | Temodal |
| Capsule 100 mg | Oral | 15 | 2 | Temodal |
| Capsule 250 mg | Oral | 5 | 5 | Temodal |
Tenecteplase | Powder for injection 40 mg with solvent | Injection | 1 | .. | Metalyse |
| Powder for injection 50 mg with solvent | Injection | 1 | .. | Metalyse |
Terbinafine | Tablet 250 mg (as hydrochloride) | Oral | 42 | .. | GenRx Terbinafine |
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| Lamisil |
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| Tamsil |
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| Terbihexal |
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| Terbinafine 250 |
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| Terbinafine‑DP |
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| Zabel |
| Cream containing terbinafine hydrochloride 10 mg per g, | Application | 2 | 3 | Lamisil |
Terbutaline | Injection containing terbutaline sulfate 500 micrograms in 1mL | Injection | 5 | .. | Bricanyl |
| Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses | Inhalation by mouth | 1 | 5 | Bricanyl Turbuhaler |
| Nebuliser solution containing terbutaline sulfate 5 mg in 2 mL single dose units, 30 | Inhalation | 2 | 5 | Bricanyl Respules |
Testosterone | Capsule containing testosterone undecanoate 40 mg | Oral | 60 | 5 | Andriol Testocaps |
| Subcutaneous implant 100 mg | Implantation | 6 | .. | Organon (Australia) Pty Limited |
| Injection containing testosterone enanthate 250 mg in 1 mL | Injection | 3 | 3 | Primoteston Depot |
| Injection containing testosterone esters (20 mg testosterone propionate, 40 mg testosterone phenylpropionate, 40 mg testosterone isocaproate) in 1 mL | Injection | 3 | 3 | Sustanon 100 |
| I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL | Injection | 1 | 1 | Reandron 1000 |
| Subcutaneous implant 200 mg | Implantation | 3 | .. | Organon (Australia) Pty Limited |
| Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate, 100 mg testosterone decanoate) in 1 mL | Injection | 3 | 3 | Sustanon 250 |
| Transdermal gel 50 mg in 5 g sachet, 30 | Transdermal | 1 | 5 | Testogel |
| Transdermal patches 12.2 mg, 60 | Transdermal | 1 | 5 | Androderm |
| Transdermal patches 24.3 mg, 30 | Transdermal | 1 | 5 | Androderm |
Tetrabenazine | Tablet 25 mg | Oral | 112 | 5 | Orphan Australia Pty Ltd |
Tetracosactrin | Compound depot injection 1 mg in 1 mL | Injection | 5 | 5 | Synacthen Depot 1 mg/1 mL |
Theophylline | Tablet 200 mg (sustained release) | Oral | 100 | 5 | Nuelin‑SR 200 |
| Tablet 250 mg (sustained release) | Oral | 100 | 5 | Nuelin‑SR 250 |
| Tablet 300 mg (sustained release) | Oral | 100 | 5 | Nuelin‑SR 300 |
| Oral solution 133.3 mg per 25 mL, 500 mL | Oral | 1 | 5 | Nuelin |
Thiamine | Tablet containing thiamine hydrochloride 100 mg | Oral | 100 | 2 | Betamin |
Thioguanine | Tablet 40 mg | Oral | 25 | 1 | Lanvis |
Thiotepa | Powder for injection 15 mg | Injection/intravesical | 2 | 1 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Thyrotropin Alfa | Powder for injection 0.9 mg, 2 | Injection | 1 | .. | Thyrogen |
Thyroxine | Tablet containing 50 micrograms anhydrous thyroxine sodium | Oral | 200 | 1 | Eutroxsig Oroxine |
| Tablet containing 100 micrograms anhydrous thyroxine sodium | Oral | 200 | 1 | Eutroxsig Oroxine |
| Tablet containing 200 micrograms anhydrous thyroxine sodium | Oral | 200 | 1 | Eutroxsig Oroxine |
Tiagabine | Tablet 5 mg (as hydrochloride) | Oral | 100 | 5 | Gabitril |
| Tablet 10 mg (as hydrochloride) | Oral | 100 | 5 | Gabitril |
| Tablet 15 mg (as hydrochloride) | Oral | 100 | 5 | Gabitril |
Tiaprofenic Acid | Tablet 300 mg | Oral | 60 | 3 | Surgam |
Ticarcillin with Clavulanic Acid | Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Timentin |
Ticlopidine | Tablet containing ticlopidine hydrochloride 250 mg | Oral | 60 | 5 | Ticlid Tilodene |
Tiludronic Acid | Tablet 200 mg (as tiludronate disodium) | Oral | 56 | 2 | Skelid |
Timolol | Eye gel 1 mg (as maleate) per g, 5 g | Application to the eye | 1 | 5 | Nyogel |
| Eye drops 2.5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Tenopt Timoptol |
| Eye drops 5 mg (as maleate) per mL, 5 mL | Application to the eye | 1 | 5 | Tenopt Timoptol |
| Eye drops (gellan gum solution) 2.5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Timoptol XE |
| Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Timoptol XE |
Tinidazole | Tablet 500 mg | Oral | 4 | .. | Fasigyn Simplotan |
Tiotropium | Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler) | Inhalation by mouth | 30 | 5 | Spiriva |
Tirofiban | Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL | Injection | 1 | 2 | Aggrastat |
Tobramycin | Injection 80 mg (as sulfate) in 2 mL | Injection | 10 | 1 | Hospira Pty Limited |
| Injection 80 mg (as sulfate) in 2 mL (without preservative) | Injection | 10 | 1 | Pfizer Australia Pty Ltd |
| Eye drops 3 mg per mL, 5 mL | Application to the eye | 1 | 2 | Tobrex |
| Eye ointment 3 mg per g, 3.5 g | Application to the eye | 1 | .. | Tobrex |
Topiramate | Tablet 25 mg | Oral | 60 | 5 | Topamax |
| Tablet 50 mg | Oral | 60 | 5 | Topamax |
| Tablet 100 mg | Oral | 60 | 5 | Topamax |
| Tablet 200 mg | Oral | 60 | 5 | Topamax |
| Capsule 15 mg | Oral | 60 | 5 | Topamax Sprinkle |
| Capsule 25 mg | Oral | 60 | 5 | Topamax Sprinkle |
| Capsule 50 mg | Oral | 60 | 5 | Topamax Sprinkle |
Topotecan | Powder for I.V. infusion 4 mg (as hydrochloride) | Injection | 5 | 1 | Hycamtin |
Toremifene | Tablet 60 mg (as citrate) | Oral | 30 | 5 | Fareston |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Oral | 20 | .. | Chem mart Tramadol |
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| GenRx Tramadol |
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| Terry White Chemists Tramadol |
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| Tramal |
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| Tramedo |
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| Zydol |
| Tablet containing tramadol hydrochloride 50 mg (sustained release) | Oral | 20 | .. | Tramal SR 50 |
| Tablet containing tramadol hydrochloride 100 mg (sustained release) | Oral | 20 | .. | Tramahexal SR Tramal SR 100 Tramedo SR 100 Zydol SR 100 |
| Tablet containing tramadol hydrochloride 150 mg (sustained release) | Oral | 20 | .. | Tramahexal SR Tramal SR 150 Tramedo SR 150 Zydol SR 150 |
| Tablet containing tramadol hydrochloride 200 mg (sustained release) | Oral | 20 | .. | Tramahexal SR Tramal SR 200 Tramedo SR 200 Zydol SR 200 |
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL | Oral | 1 | .. | Tramal |
| Injection containing tramadol hydrochloride 100 mg in 2 mL | Injection | 5 | .. | Tramahexal Tramal 100 |
Trandolapril | Capsule 500 micrograms | Oral | 28 | 5 | Dolapril 0.5 Gopten Odrik Tranalpha |
| Capsule 1 mg | Oral | 28 | 5 | Dolapril 1 Gopten Odrik Tranalpha |
| Capsule 2 mg | Oral | 28 | 5 | Dolapril 2 Gopten Odrik Tranalpha |
| Capsule 4 mg | Oral | 28 | 5 | Dolapril 4 Gopten Tranalpha |
Trandolapril with Verapamil | Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release) | Oral | 28 | 5 | Tarka 4/240 |
Tranexamic Acid | Tablet 500 mg | Oral | 100 | 2 | Cyklokapron |
Tranylcypromine | Tablet 10 mg (as sulfate) | Oral | 50 | 2 | Parnate |
Travoprost | Eye drops 40 micrograms per mL, 2.5 mL | Application to the eye | 1 | 5 | Travatan |
Travoprost with Timolol | Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL | Application to the eye | 1 | 5 | Duotrav |
Triamcinolone | Injection containing triamcinolone acetonide 10 mg in 1 mL | Injection | 5 | .. | Kenacort‑A10 |
| Cream containing triamcinolone acetonide 200 micrograms per g, 100 g | Application | 2 | .. | Aristocort 0.02% Tricortone |
| Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g | Application | 2 | .. | Aristocort 0.02% Tricortone |
Triamcinolone with Neomycin, Gramicidin and Nystatin | Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL | Application to the ear | 1 | 2 | Kenacomb Otic Otocomb Otic |
| Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g | Application to the ear | 1 | 2 | Kenacomb Otic Otocomb Otic |
Trifluoperazine | Tablet 1 mg (as hydrochloride) | Oral | 100 | 5 | Stelazine |
| Tablet 2 mg (as hydrochloride) | Oral | 100 | 5 | Stelazine |
| Tablet 5 mg (as hydrochloride) | Oral | 100 | 5 | Stelazine |
Triglycerides, medium chain | Oil 500 mL (MCT Oil) | Oral | 2 | 5 | MCT Oil |
Triglycerides, medium chain and long chain with glucose polymer | Oral powder 400 g (Duocal) | Oral | 8 | 5 | Duocal |
Triglycerides — medium chain, formula | Oral powder 400 g (Monogen) | Oral | 8 | 5 | Monogen |
| Oral powder 420 g (Caprilon) | Oral | 8 | 5 | Caprilon |
Trimethoprim | Tablet 300 mg | Oral | 7 | 1 | Alprim Triprim |
Trimethoprim with Sulfamethoxazole | Tablet 80 mg‑400 mg | Oral | 10 | 1 | Resprim |
| Tablet 160 mg‑800 mg | Oral | 10 | 1 | Bactrim DS |
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| Chem mart Trimethoprim with Sulfamethoxazole DS |
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| GenRx Trimethoprim with Sulfamethoxazole DS |
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| Resprim Forte |
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| Septrin Forte |
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|
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| Terry White Chemists Trimethoprim with Sulfamethoxazole DS |
| Paediatric oral suspension 40 mg‑200 mg per 5 mL, 100 mL | Oral | 1 | 1 | Bactrim Septrin |
Tropisetron | Capsule 5 mg (as hydrochloride) | Oral | 2 | .. | Navoban |
| I.V. injection 5 mg (as hydrochloride) in 5 mL | Injection | 1 | .. | Navoban |
Tyrosine with carbohydrate | Sachets of oral powder 4 g containing 1 g tyrosine, 30 | Oral | 4 | 5 | Tyrosine Amino Acid Supplement |
Ursodeoxycholic Acid | Capsule 250 mg | Oral | 100 | 2 | Ursofalk |
Valaciclovir | Tablet 500 mg (as hydrochloride) | Oral | 20 | .. | Valtrex |
Valine with carbohydrate | Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine Amino Acid Supplement) | Oral | 4 | 5 | Valine Amino Acid Supplement |
Valproic Acid | Tablet, crushable, containing sodium valproate 100 mg | Oral | 200 | 2 | Epilim |
| Tablet (enteric coated) containing sodium valproate 200 mg | Oral | 200 | 2 | Epilim EC |
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| Sodium Valproate Sandoz |
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| Valpro 200 |
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| Valproate Winthrop EC 200 |
| Tablet (enteric coated) containing sodium valproate 500 mg | Oral | 200 | 2 | Epilim EC |
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| Sodium Valproate Sandoz |
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| Valpro 500 |
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| Valproate Winthrop EC 500 |
| Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL | Oral | 2 | 2 | Epilim Liquid |
| Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL | Oral | 2 | 2 | Epilim Syrup |
Vancomycin | Capsule 125 mg (125,000 I.U.) (as hydrochloride) | Oral | 40 | .. | Vancocin |
| Capsule 250 mg (250,000 I.U.) (as hydrochloride) | Oral | 40 | .. | Vancocin |
| Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | 2 | .. | Hospira Pty Limited Vancocin CP Vancomycin Sandoz |
| Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | 1 | .. | Hospira Pty Limited Vancomycin Sandoz |
Varenicline | Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack | Oral | 1 | .. | Champix |
| Tablet 1 mg (as tartrate) | Oral | 112 | .. | Champix |
Venlafaxine | Capsule (modified release) 37.5 mg (as hydrochloride) | Oral | 28 | .. | Efexor‑XR |
| Capsule (modified release) 75 mg (as hydrochloride) | Oral | 28 | 5 | Efexor‑XR |
| Capsule (modified release) 150 mg (as hydrochloride) | Oral | 28 | 5 | Efexor‑XR |
Verapamil | Tablet containing verapamil hydrochloride 40 mg | Oral | 100 | 5 | Anpec 40 Isoptin |
| Tablet containing verapamil hydrochloride 80 mg | Oral | 100 | 5 | Anpec 80 Isoptin |
| Tablet containing verapamil hydrochloride 120 mg | Oral | 100 | 5 | Isoptin |
| Tablet containing verapamil hydrochloride 160 mg | Oral | 60 | 5 | Isoptin |
| Tablet containing verapamil hydrochloride 180 mg (sustained release) | Oral | 30 | 5 | Cordilox 180 SR Isoptin 180 SR |
| Tablet containing verapamil hydrochloride 240 mg (sustained release) | Oral | 30 | 5 | Anpec SR Cordilox SR Isoptin SR |
| Capsule containing verapamil hydrochloride 160 mg (sustained release) | Oral | 30 | 5 | Veracaps SR |
| Capsule containing verapamil hydrochloride 240 mg (sustained release) | Oral | 30 | 5 | Veracaps SR |
| Injection containing verapamil hydrochloride 5 mg in 2 mL | Injection | 5 | .. | Isoptin |
Verteporfin | Powder for I.V. infusion 15 mg | Injection | 1 | .. | Visudyne |
Vigabatrin | Tablet 500 mg | Oral | 100 | 5 | Sabril |
| Oral powder, sachet 500 mg | Oral | 60 | 5 | Sabril |
Vinblastine | Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL | Injection | 5 | .. | Hospira Pty Limited |
Vincristine | I.V. injection containing vincristine sulfate 1 mg in 1 mL | Injection | 10 | .. | Hospira Pty Limited Pfizer Australia Pty Ltd |
Vinorelbine | Capsule 20 mg (as tartrate) | Oral | 20 | 2 | Navelbine |
| Capsule 30 mg (as tartrate) | Oral | 16 | 2 | Navelbine |
| Solution for I.V. infusion 10 mg (as tartrate) in 1 mL | Injection | 16 | 2 | Hospira Pty Limited Navelbine Vinorelbine Ebewe |
| Solution for I.V. infusion 50 mg (as tartrate) in 5 mL | Injection | 4 | 2 | Hospira Pty Limited Navelbine Vinorelbine Ebewe |
Warfarin | Tablet containing warfarin sodium 1 mg | Oral | 50 | 2 | Coumadin Marevan |
| Tablet containing warfarin sodium 2 mg | Oral | 50 | 2 | Coumadin |
| Tablet containing warfarin sodium 3 mg | Oral | 50 | 2 | Marevan |
| Tablet containing warfarin sodium 5 mg | Oral | 50 | 2 | Coumadin Marevan |
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | Oral powder 400 g (Kindergen) | Oral | 16 | 5 | Kindergen |
Ziprasidone | Capsule 20 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox |
| Capsule 40 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox |
| Capsule 60 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox |
| Capsule 80 mg (as hydrochloride) | Oral | 60 | 5 | Zeldox |
Zolmitriptan | Tablet 2.5 mg | Oral | 4 | 5 | Zomig |
Zuclopenthixol Decanoate | Oily I.M. injection 200 mg in 1 mL ampoule | Injection | 5 | .. | Clopixol Depot |
Aciclovir | Tablet 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 90 | 5 | Aciclovir 200 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Acihexal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Acyclo‑V 200 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Chem mart Aciclovir | ||||||||||||||||||||||||||||||||||||||||||||||||
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| GenRx Aciclovir | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Lovir | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Ozvir | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Terry White Chemists Aciclovir | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Zovirax 200 mg | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 800 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L) | Oral | 120 | 5 | Acihexal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Acyclo‑V 800 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Lovir | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Zovirax 800 mg | ||||||||||||||||||||||||||||||||||||||||||||||||
Adalimumab | Injection 40 mg in 0.8 mL pre‑filled syringe |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with adalimumab within an ongoing biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 2 | 5 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
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| (a) who have a documented history of severe active rheumatoid arthritis; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (b) who have demonstrated an adequate response to treatment with adalimumab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (c) whose most recent course of PBS‑subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| a patient will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (b) if the course of therapy is a 16‑week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| if the most recent course of adalimumab therapy was a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the patient has not failed to demonstrate response to a course of PBS‑subsidised adalimumab in this Treatment Cycle; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled syringe |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 3 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (1) have severe active psoriatic arthritis; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with adalimumab during the current Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled syringe |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 5 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with adalimumab prior to 16 March 2006; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| patients are eligible for PBS-subsidised treatment under the above criteria once only |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (1) who have a documented history of severe active psoriatic arthritis; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled syringe |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 2 | 3 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS‑subsidised treatment with one of these drugs, has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS‑subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS‑subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS‑subsidised therapy with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS‑subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled syringe |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS‑subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and | Injection | 2 | 5 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who is receiving treatment with adalimumab at the time of application; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who has not received prior PBS‑subsidised treatment with infliximab or etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0‑10 scale or improved by at least 2 from baseline; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (d) who has: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) an ESR or CRP measurement reduced by at least 20% from pre‑treatment baseline; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS‑subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS‑subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS‑subsidised treatment under the above criteria once only |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS‑subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non‑PBS‑subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS‑subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS‑subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS‑subsidised treatment and is continuing to receive PBS‑subsidised treatment in their first treatment cycle, and where pre‑treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS‑subsidised treatment, or no greater than 2, and 1 of the following: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled pen |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with adalimumab within an ongoing biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 2 | 5 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS‑subsidised bDMARD treatment in this bDMARD Treatment Cycle was with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16‑week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of adalimumab therapy was a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS‑subsidised adalimumab in this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled pen |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 3 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with adalimumab during the current Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled pen |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 5 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with adalimumab prior to 16 March 2006; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled pen |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 2 | 3 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS‑subsidised treatment with one of these drugs, has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (b) who has at least 2 of the following: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (iii) limitation of chest expansion relative to normal values for age and gender; and |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS‑subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS‑subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS‑subsidised therapy with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS‑subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 40 mg in 0.8 mL pre‑filled pen |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a treatment cycle with an initial PBS‑subsidised course of adalimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with adalimumab prior to 1 November 2006; and | Injection | 2 | 5 | Humira | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who is receiving treatment with adalimumab at the time of application; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who has not received prior PBS‑subsidised treatment with infliximab or etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) whose current Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is either less than or equal to 5 on a 0‑10 scale or improved by at least 2 from baseline; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (d) who has: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) an ESR or CRP measurement reduced by at least 20% from pre‑treatment baseline; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (e) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS‑subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS‑subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the BASDAI assessment and the ESR and CRP measurements provided are no more than 1 month old at the time of application; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS‑subsidised treatment under the above criteria once only |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS‑subsidised treatment commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non‑PBS‑subsidised treatment with adalimumab prior to 1 November 2006 and at the time of the initial application for PBS‑subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS‑subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with adalimumab, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with adalimumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with adalimumab prior to 1 November 2006, was subsequently commenced on PBS‑subsidised treatment and is continuing to receive PBS‑subsidised treatment in their first treatment cycle, and where pre‑treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS‑subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Adrenaline | I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector |
| In compliance with authority procedures set out in subparagraph 11 (d): Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto‑injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application | Injection | 2 | .. | EpiPen Jr. | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto‑injectors is necessary to ensure 1 is on hand at all times |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto‑injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector |
| In compliance with authority procedures set out in subparagraph 11 (d): Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto‑injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application | Injection | 2 | .. | EpiPen | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto‑injectors is necessary to ensure 1 is on hand at all times |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto‑injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Albendazole | Tablet 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 6 | 1 | Zentel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
| 1525 | Treatment of tapeworm infestation |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Amino acids — synthetic, formula | Oral powder 400 g (EleCare) |
| In compliance with authority procedures set out in subparagraph 11 (d): Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where: | Oral | 12 | 5 | EleCare | ||||||||||||||||||||||||||||||||||||||||||||||||
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| eosinophilic oesophagitis is demonstrated by the following criteria: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (i) chronic symptoms of reflux that persisted despite a 2‑month trial of a proton pump inhibitor or chronic dysphagia; and |
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| (ii) a lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies; |
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| the date of birth of the patient is included in the authority application; |
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| treatment with oral steroids is not commenced during the period of initial treatment |
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| Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS‑subsidised treatment, and where: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies; |
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| the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment |
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| Oral powder 400 g (EleCare) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | EleCare | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral powder 400 g (Neocate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral powder 400 g (Neocate Advance) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate Advance | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral powder 400 g (Neocate Advance Tropical Flavour) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate Advance Tropical Flavour | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids | Oral powder 400 g (Neocate LCP) |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | Oral | 8 | 5 | Neocate LCP | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Amoxycillin | Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of infections suspected or proven to be due to a susceptible organism in patients who require a liquid formulation and in whom the syrup formulations are unsuitable | Oral | 1 | 1 | Amoxil | ||||||||||||||||||||||||||||||||||||||||||||||||
Anakinra | Injection 100 mg in 0.67 mL single use pre‑filled syringe |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with anakinra within an ongoing biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 28 | 5 | Kineret | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with anakinra; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS‑subsidised bDMARD treatment in this bDMARD Treatment Cycle was with anakinra; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16‑week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of anakinra therapy was a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS‑subsidised anakinra in this Treatment Cycle; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Azithromycin | Tablet 500 mg (as dihydrate) |
| Trachoma | Oral | 2 | 2 | Zithromax | ||||||||||||||||||||||||||||||||||||||||||||||||
Benzathine Penicillin | Powder for injection 900 mg |
| Syphilis | Injection | 2 | .. | Pan Benzathine Benzylpenicillin | ||||||||||||||||||||||||||||||||||||||||||||||||
Bortezomib | Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient with a World Health Organisation (WHO) performance status of 2 or less, who has progressive disease, who has received at least 1 prior therapy (other than thalidomide), who has undergone or is ineligible for a primary stem cell transplant and who has experienced treatment failure after a trial of at least 4 weeks of thalidomide at a dose of at least 100 mg daily; and | Injection | 4 | 3 | Velcade | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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|
| if the dosing requirement for thalidomide cannot be met, the authority application states the reasons why this criterion cannot be satisfied; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| thalidomide treatment failure is defined as: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) confirmed disease progression during or within 6 months of discontinuing thalidomide treatment; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) severe intolerance or toxicity unresponsive to clinically appropriate dose adjustment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| progressive disease is defined as at least 1 of the following: |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (d) an increase in the size or number of lytic bone lesions (not including compression fractures); or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (e) at least a 25% increase in the size of an existing, or the development of a new, soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (f) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause); |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| severe intolerance due to thalidomide is defined as unacceptable somnolence or sedation interfering with activities of daily living; |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| toxicity from thalidomide is defined as peripheral neuropathy (Grade 2 or greater, interfering with function), drug‑related seizures, serious Grade 3 or Grade 4 drug‑related dermatological reactions, such as Stevens‑Johnson Syndrome, or other Grade 3 or 4 toxicity; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the authority application includes: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (1) a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form, which includes details of prior treatments including names of drugs and date of most recent treatment cycle and record of prior stem cell transplant or ineligibility for prior stem cell transplant; the patient's WHO performance status; details of thalidomide treatment failure; details of the basis of the diagnosis of progressive disease; nomination of which disease activity parameters will be used to assess response; and the results of current diagnostic reports as detailed below; and |
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| (2) duration of thalidomide and daily dose prescribed; and |
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| (3) a signed patient acknowledgment; |
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|
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| to enable the Medicare Australia CEO to confirm response, current diagnostic reports of the following are required to establish baseline: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (a) the level of serum M protein (monoclonal protein); and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (b) if Bence‑Jones proteinuria is present, the results of 24‑hour urinary light chain M protein excretion; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| if neither serum M protein nor urine Bence‑Jones protein is present in measurable quantities, additional diagnostic reports are required, including: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (c) bone marrow aspirate and trephine; and |
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| (d) if present, the size and location of lytic bone lesions (not including compression fractures); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (e) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination, i.e. magnetic resonance imaging or computed tomography scan; or |
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| (f) if present, the level of hypercalcaemia, corrected for albumin concentration; or |
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| (g) if present, the serum free light chain levels; |
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|
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| to enable assessment of response, baseline values for the above parameters must be provided with the authority application as follows: |
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| (i) for all patients, results for (a) and (b) must be provided; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (ii) where the patient has oligo‑secretory or non‑secretory multiple myeloma, results for (c) and if relevant (d), (e) or (f) must be provided; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (iii) where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, results for (g) must be provided; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where baseline values for 1 or more of the specified parameters cannot be provided, the authority application states the reason or reasons these cannot be provided |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS‑subsidised treatment, as monotherapy or in combination with a corticosteroid, of multiple myeloma in a patient who has previously received 4 treatment cycles of bortezomib and who, at the time of application, has demonstrated at least a partial response to bortezomib; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if serum M protein and urine Bence‑Jones protein levels are measurable, partial response (PR) compared with baseline (prior to treatment with bortezomib) is defined as: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (a) at least a 50% reduction in the level of serum M protein (monoclonal protein); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (b) at least a 90% reduction in 24‑hour urinary light chain M protein excretion or to less than 200 mg per 24 hours; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if serum M protein and urine Bence‑Jones protein levels are unmeasurable as in non‑secretory/oligo‑secretory multiple myeloma, partial response compared with baseline is defined as: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (c) at least a 50% reduction in the difference between involved and uninvolved serum free light chain (FLC) levels; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if serum M protein and urine Bence‑Jones protein and serum FLC are unmeasurable/unavailable, partial response compared with baseline is defined as: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (d) at least a 50% reduction in bone marrow plasma cells; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (e) normalisation of corrected serum calcium to less than or equal to 2.65 mmol per L; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (f) no increase in size or number of lytic bone lesions (development of compression fracture does not exclude response); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (g) at least a 50% reduction in the size of soft tissue plasmacytoma (by clinical or applicable radiographic examination, i.e. magnetic resonance imaging or computed tomography scan); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same parameters provided for the diagnosis of progressive disease are used to demonstrate at least a partial response to treatment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient is eligible for continuing PBS‑subsidised bortezomib treatment beyond 4 cycles if they have achieved at least a partial response at the completion of cycle 4, and the results of the response assessment are included in the application for authorisation of further treatment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| a patient will be deemed to have failed to respond to 4 cycles of treatment with bortezomib, despite demonstrating a partial response, if the response assessment is not submitted to the Medicare Australia CEO prior to cycle 5; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application is made not later than 6 months after the application for initial treatment and includes: |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Multiple Myeloma Authority Application ‑ Supporting Information Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) diagnostic reports, which are no more than 1 month old at the time of application, demonstrating that the patient has achieved at least a partial response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who fail to demonstrate at least a partial response after 8 cycles are not eligible to receive further PBS‑subsidised treatment with bortezomib; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| a patient is eligible to receive no more than 2 cycles of treatment beyond the cycle at which a complete response, confirmed by 2 determinations a minimum of 6 weeks apart, was first achieved |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Bromocriptine | Tablet 2.5 mg (as mesylate) |
| Acromegaly | Oral | 60 | 5 | Kripton 2.5 Parlodel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Parkinson's disease |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Pathological hyperprolactinaemia where surgery is not indicated |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Pathological hyperprolactinaemia where radiotherapy is not indicated |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Buprenorphine | Transdermal patch 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 4 | .. | Norspan | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Transdermal patch 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 4 | .. | Norspan | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Transdermal patch 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 4 | .. | Norspan | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Completion of short‑term, sole PBS‑subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program | Oral | 90 | .. | Bupropion‑RL Clorprax Prexaton Zyban | ||||||||||||||||||||||||||||||||||||||||||||||||
Cabergoline | Tablet 500 micrograms |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 8 | 5 | Dostinex | ||||||||||||||||||||||||||||||||||||||||||||||||
|
| 2659 | Pathological hyperprolactinaemia where surgery is not indicated |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
| 2660 | Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
| 2661 | Pathological hyperprolactinaemia where radiotherapy is not indicated |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
| 2662 | Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Ceftriaxone | Powder for injection 500 mg (as sodium) |
| Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected Septicaemia, proven | Injection | 5 | .. | Ceftriaxone ICP | ||||||||||||||||||||||||||||||||||||||||||||||||
Cetuximab | Solution for I.V. infusion 100 mg in 20 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux | ||||||||||||||||||||||||||||||||||||||||||||||||
| Solution for I.V. infusion 100 mg in 50 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux | ||||||||||||||||||||||||||||||||||||||||||||||||
| Solution for I.V. infusion 500 mg in 100 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated | Injection | 1 | 6 | Erbitux | ||||||||||||||||||||||||||||||||||||||||||||||||
Chorionic Gonadotrophin | Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL |
| Cryptorchism not due to organic obstruction in boys over 12 months of age | Injection | 2 | 1 | Pregnyl | ||||||||||||||||||||||||||||||||||||||||||||||||
Ciprofloxacin | Tablet 250 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Respiratory tract infection proven or suspected to be caused by Bacterial gastroenteritis in severely immunocompromised patients Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram‑negative bacteria resistant to all other oral antimicrobials Treatment of joint and bone infections, epididymo‑orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram‑negative bacteria or gram‑positive bacteria resistant to all other appropriate antimicrobials | Oral | 14 | .. | C‑Flox 250 Cifran Ciprol 250 Ciproxin 250 GenRx Ciprofloxacin Profloxin | ||||||||||||||||||||||||||||||||||||||||||||||||
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment (for up to 6 months) of severe disabling pain not responding to non‑narcotic analgesics, at a dose not exceeding 8 tablets per day | Oral | 60 | .. | Codalgin Forte | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Codapane Forte | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Comfarol Forte | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Dolaforte | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Panadeine Forte | ||||||||||||||||||||||||||||||||||||||||||||||||
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|
|
| Prodeine Forte | ||||||||||||||||||||||||||||||||||||||||||||||||
Cyproterone | Tablet containing cyproterone acetate 50 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 100 | 5 | Androcur Cyprohexal Cyprone Cyprostat GenRx Cyproterone Acetate Procur | ||||||||||||||||||||||||||||||||||||||||||||||||
|
| 1014 | Advanced carcinoma of the prostate |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||
|
| 1404 | To reduce drive in sexual deviations in males |
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| |||||||||||||||||||||||||||||||||||||||||||||||||
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| |||||||||||||||||||||||||||||||||||||||||||||||||
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| |||||||||||||||||||||||||||||||||||||||||||||||||
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| |||||||||||||||||||||||||||||||||||||||||||||||||
Dalteparin | Injection containing dalteparin sodium 2,500 I.U. (anti‑Xa) in 0.2 mL single dose pre‑filled syringe |
| Haemodialysis | Injection | 20 | 3 | Fragmin | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection containing dalteparin sodium 5,000 I.U. (anti‑Xa) in 0.2 mL single dose pre‑filled syringe |
| Haemodialysis | Injection | 20 | 3 | Fragmin | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection containing dalteparin sodium 7,500 I.U. (anti‑Xa) in 0.75 mL single dose pre‑filled syringe |
| Haemodialysis | Injection | 20 | 3 | Fragmin | ||||||||||||||||||||||||||||||||||||||||||||||||
Dasatinib | Tablet 20 mg |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, as the sole PBS‑subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR‑ABL, and who: | Oral | 60 | 5 | Sprycel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR‑ABL and morphological evidence of leukaemia); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) lack of response to initial imatinib therapy, defined as either: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a major cytogenetic response or a peripheral blood BCR‑ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — peripheral basophils greater than or equal to 20%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) blast crisis is defined as either: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — extramedullary involvement other than spleen and liver; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first‑line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (v) detection of a mutation in BCR‑ABL (L248V, G250E, Q252H/R, Y253H/F, E255K/V, H396P/R, and D276G) that infers high level imatinib resistance; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (vi) grade 3 or 4 non‑haematological toxicity that is imatinib related; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib PBS Authority Application ‑ Supporting Information Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of chronic myeloid leukaemia plus qualitative RT‑PCR evidence of BCR‑ABL transcript, and the date of the relevant pathology report; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (e) a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement or details of Grade 3 or 4 non‑haematological toxicity |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR‑ABL level in the blood, due to dasatinib therapy, in the preceding 12 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a bone marrow or peripheral blood BCR‑ABL level of less than 1% on the international scale (Blood 108: 28‑37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response to PBS‑subsidised treatment with dasatinib is assessed by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR‑ABL specific probe; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of BCR‑ABL transcript in the peripheral blood using the international scale; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 12 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been sustained; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib Authority Application Form for continuing treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) demonstration of continued response to treatment as evidenced by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR‑ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR‑ABL specific probe because standard karyotyping was not informative, a copy of the non‑informative standard karyotype analysis; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS‑subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS‑subsidised re‑treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 50 mg |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, as the sole PBS‑subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR‑ABL, and who: | Oral | 60 | 5 | Sprycel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR‑ABL and morphological evidence of leukaemia); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) lack of response to initial imatinib therapy, defined as either: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a major cytogenetic response or a peripheral blood BCR‑ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — peripheral basophils greater than or equal to 20%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) blast crisis is defined as either: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — extramedullary involvement other than spleen and liver; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first‑line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (v) detection of a mutation in BCR‑ABL (L248V, G250E, Q252H/R, Y253H/F, E255K/V, H396P/R, and D276G) that infers high level imatinib resistance; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (vi) grade 3 or 4 non‑haematological toxicity that is imatinib related; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib PBS Authority Application ‑ Supporting Information Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of chronic myeloid leukaemia plus qualitative RT‑PCR evidence of BCR‑ABL transcript, and the date of the relevant pathology report; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (e) a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement or details of Grade 3 or 4 non‑haematological toxicity |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR‑ABL level in the blood, due to dasatinib therapy, in the preceding 12 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a bone marrow or peripheral blood BCR‑ABL level of less than 1% on the international scale (Blood 108: 28‑37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response to PBS‑subsidised treatment with dasatinib is assessed by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR‑ABL specific probe; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of BCR‑ABL transcript in the peripheral blood using the international scale; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 12 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been sustained; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib Authority Application Form for continuing treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) demonstration of continued response to treatment as evidenced by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR‑ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR‑ABL specific probe because standard karyotyping was not informative, a copy of the non‑informative standard karyotype analysis; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS‑subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS‑subsidised re‑treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 70 mg |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, as the sole PBS‑subsidised therapy, of a patient with chronic myeloid leukaemia in any disease phase bearing the Philadelphia chromosome or expressing the transcript BCR‑ABL, and who: | Oral | 60 | 5 | Sprycel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) has active leukaemia (as defined by the presence on current pathology assessments of either the Philadelphia chromosome on cytogenetic or fluorescence in situ hybridisation (FISH) analysis, or the presence of the transcript BCR‑ABL and morphological evidence of leukaemia); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) has failed an adequate trial of imatinib, where failure of an adequate trial of imatinib is defined as: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) lack of response to initial imatinib therapy, defined as either: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a haematological response after a minimum of 3 months of therapy with imatinib, for patients initially treated in chronic phase; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve any cytogenetic response after a minimum of 6 months of therapy with imatinib, for patients initially treated in chronic phase as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — failure to achieve a major cytogenetic response or a peripheral blood BCR‑ABL level of less than 1% after a minimum of 12 months of therapy with imatinib; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Philadelphia positive cells on bone marrow biopsy), during ongoing imatinib therapy; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) development of accelerated phase or blast crisis in a patient previously prescribed imatinib for any phase of chronic myeloid leukaemia, where: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — peripheral basophils greater than or equal to 20%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) blast crisis is defined as either: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — extramedullary involvement other than spleen and liver; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during first‑line imatinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (v) detection of a mutation in BCR‑ABL (L248V, G250E, Q252H/R, Y253H/F, E255K/V, H396P/R, and D276G) that infers high level imatinib resistance; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (vi) grade 3 or 4 non‑haematological toxicity that is imatinib related; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib PBS Authority Application ‑ Supporting Information Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a signed patient acknowledgement; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) a bone marrow biopsy pathology report demonstrating that the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of chronic myeloid leukaemia plus qualitative RT‑PCR evidence of BCR‑ABL transcript, and the date of the relevant pathology report; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (e) a copy of the current confirming pathology report, or reports, from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement or details of Grade 3 or 4 non‑haematological toxicity |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has received initial treatment with dasatinib as a pharmaceutical benefit for chronic myeloid leukaemia, and who has demonstrated either a major cytogenetic response, or less than 1% BCR‑ABL level in the blood, due to dasatinib therapy, in the preceding 12 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a bone marrow or peripheral blood BCR‑ABL level of less than 1% on the international scale (Blood 108: 28‑37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response to PBS‑subsidised treatment with dasatinib is assessed by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR‑ABL specific probe; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of BCR‑ABL transcript in the peripheral blood using the international scale; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 12 months of the commencement of treatment with dasatinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR‑ABL level of less than 1% has been sustained; |
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| the authority application includes: |
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| (1) a completed copy of the appropriate Chronic Myeloid Leukaemia Dasatinib Authority Application Form for continuing treatment; and |
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| (2) demonstration of continued response to treatment as evidenced by: |
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| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of BCR‑ABL of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and |
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| (3) if the cytogenetic analysis submitted with the application was conducted using FISH with BCR‑ABL specific probe because standard karyotyping was not informative, a copy of the non‑informative standard karyotype analysis; |
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| a patient who has previously received PBS‑subsidised treatment with dasatinib and has at any time failed to meet the criteria for continuing treatment, is not eligible for PBS‑subsidised re‑treatment |
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Desmopressin | Tablet containing desmopressin acetate 200 micrograms |
1678 | In compliance with authority procedures set out in subparagraph 11 (d):
Cranial diabetes insipidus | Oral | 90 | 5 | Minirin | ||||||||||||||||||||||||||||||||||||||||||||||||
| Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL |
1678 | In compliance with authority procedures set out in subparagraph 11 (d):
Cranial diabetes insipidus | Nasal | 2 | 5 | Minirin Nasal Spray | ||||||||||||||||||||||||||||||||||||||||||||||||
Diazepam | Tablet 2 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Disabling spasticity Malignant neoplasia (late stage) | Oral | 100 | .. | Antenex 2 Ducene Valium Valpam 2 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| For use by patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
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| For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Disabling spasticity Malignant neoplasia (late stage) For use by patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal | Oral | 100 | .. | Antenex 5 Diazepam‑DP Ducene Valium Valpam 5 | ||||||||||||||||||||||||||||||||||||||||||||||||
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Doxycycline | Tablet 100 mg (as monohydrate) |
| Pelvic inflammatory disease | Oral | 28 | .. | Chem mart Doxycycline | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Doxyhexal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| GenRx Doxycycline | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Terry White Chemists Doxycycline | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 100 mg (as monohydrate) |
| Urethritis | Oral | 21 | .. | Chem mart Doxycycline | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Doxyhexal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| GenRx Doxycycline | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Terry White Chemists Doxycycline | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 100 mg (as hydrochloride) |
| Pelvic inflammatory disease | Oral | 28 | .. | Doxsig | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Doxy‑100 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Doxylin 100 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Vibramycin | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 100 mg (as hydrochloride) |
| Urethritis | Oral | 21 | .. | Doxsig | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Doxy‑100 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Doxylin 100 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Vibramycin | ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) |
| Pelvic inflammatory disease | Oral | 28 | .. | DBL Doxycycline Doryx | ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) |
| Urethritis | Oral | 21 | .. | DBL Doxycycline Doryx | ||||||||||||||||||||||||||||||||||||||||||||||||
Efalizumab | Injection set containing 4 vials powder for injection 125 mg and 4 pre‑filled syringes diluent 1.3 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: | Injection | 1 | 5 | Raptiva | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (a) who have a documented history of severe chronic plaque psoriasis; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (b) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where biological agent means efalizumab, etanercept or infliximab; and |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to efalizumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment; |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the PASI assessment is performed on the same affected body area assessed to establish the baseline pre‑treatment PASI score; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16‑week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24‑week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date the course of treatment ceased; |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless the response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means efalizumab, etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to efalizumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values established prior to biological agent treatment; or |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value established prior to biological agent treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the PASI assessment is performed on the same affected body area assessed to establish the baseline pre‑treatment PASI score; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16‑week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24‑week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date the course of treatment ceased; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless the response assessment is undertaken and submitted to the Medicare Australia CEO within the timeframes specified above; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Enoxaparin | Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti‑Xa) in 0.2 mL pre‑filled syringe |
| Haemodialysis | Injection | 20 | 3 | Clexane | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti‑Xa) in 0.4 mL pre‑filled syringe |
| Haemodialysis | Injection | 20 | 3 | Clexane | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti‑Xa) in 0.6 mL pre‑filled syringe |
| Haemodialysis | Injection | 20 | 3 | Clexane | ||||||||||||||||||||||||||||||||||||||||||||||||
Escitalopram | Oral solution 10 mg (as oxalate) per mL, 28 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | Oral | 1 | 5 | Lexapro | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance |
|
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Esomeprazole | Tablet (enteric coated) 20 mg (as magnesium trihydrate) |
| Maintenance of healed gastro‑oesophageal reflux disease | Oral | 30 | 5 | Nexium | ||||||||||||||||||||||||||||||||||||||||||||||||
Etanercept | Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 2 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS‑subsidised treatment with one of these drugs, has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS‑subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS‑subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS‑subsidised therapy with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS‑subsidised adalimumab, etanercept or infliximab therapy, where: |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with etanercept; and | Injection | 2 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS‑subsidised treatment prior to 1 March 2007 and is continuing to receive PBS‑subsidised treatment in their first treatment cycle, and where pre‑treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS‑subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with etanercept during the current Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 2 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with etanercept prior to 17 March 2005; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 2 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) have not previously received PBS‑subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS‑subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised bDMARD treatment for this condition was approved; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non‑biological disease modifying anti‑rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS‑subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non‑biological DMARD, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS‑subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) have not failed previous PBS‑subsidised treatment with etanercept during this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS‑subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS‑subsidised treatment of rheumatoid arthritis, to their most recent course of PBS‑subsidised etanercept treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS‑subsidised treatment was a 16‑week initial treatment course; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS‑subsidised etanercept therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS‑subsidised treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti‑rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above‑mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C‑reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C‑reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:: | Injection | 2 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS‑subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16‑week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS‑subsidised etanercept in this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS‑subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS‑subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS‑subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS‑subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| authority applications for re‑treatment with etanercept following a break in PBS‑subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 50 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 1 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS‑subsidised treatment with one of these drugs, has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (b) who has at least 2 of the following: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (iii) limitation of chest expansion relative to normal values for age and gender; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS‑subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS‑subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| failure to achieve an adequate response is demonstrated by: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS‑subsidised therapy with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS‑subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 50 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with etanercept; and | Injection | 1 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS‑subsidised treatment prior to 1 March 2007 and is continuing to receive PBS‑subsidised treatment in their first treatment cycle, and where pre‑treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS‑subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 50 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with etanercept during the current Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 50 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with etanercept prior to 17 March 2005; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 50 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 1 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) have not previously received PBS‑subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS‑subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised bDMARD treatment for this condition was approved; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non‑biological disease modifying anti‑rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS‑subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non‑biological DMARD, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) have a documented history of severe active rheumatoid arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) have received prior PBS‑subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) have not failed previous PBS‑subsidised treatment with etanercept during this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS‑subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS‑subsidised treatment of rheumatoid arthritis, to their most recent course of PBS‑subsidised etanercept treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS‑subsidised treatment was a 16‑week initial treatment course; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS‑subsidised etanercept therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS‑subsidised treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti‑rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above‑mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C‑reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C‑reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection set containing 4 vials powder for injection 50 mg and 4 pre‑filled syringes solvent 1 mL |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 1 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (b) who have demonstrated an adequate response to treatment with etanercept; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (c) whose most recent course of PBS‑subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| a patient will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (b) if the course of therapy is a 16‑week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| if the most recent course of etanercept therapy was a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| the patient has not failed to demonstrate response to a course of PBS‑subsidised etanercept in this Treatment Cycle; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS‑subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS‑subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS‑subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS‑subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| authority applications for re‑treatment with etanercept following a break in PBS‑subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre‑filled syringes, 4 |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: | Injection | 1 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who has not received any treatment with adalimumab, etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS‑subsidised treatment with one of these drugs, has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who has at least 2 of the following: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) limitation of chest expansion relative to normal values for age and gender; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised therapy with adalimumab, etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (d) who has signed a patient acknowledgment form declaring that they understand and acknowledge that PBS‑subsidised treatment with adalimumab, etanercept and infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS‑subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| both ESR and CRP measurements are included in the authority application and are no more than 1 month old; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) a completed BASDAI Assessment Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) a signed patient acknowledgment form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised treatment with adalimumab, etanercept or infliximab for this condition and has not failed PBS‑subsidised therapy with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their assessment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application is accompanied by the results of the patient's most recent course of PBS‑subsidised adalimumab, etanercept or infliximab therapy, where: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the response assessment to the previous course of treatment with adalimumab, etanercept or infliximab is not submitted as detailed above, the patient is deemed to have failed therapy with that particular course of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre‑filled syringes, 4 |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated a response to treatment with etanercept, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with etanercept; and | Injection | 1 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS‑subsidised treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with adalimumab, etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised courses of treatment with each of the 3 drugs once, at which point the patient is no longer eligible for treatment with adalimumab, etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who commenced PBS‑subsidised treatment with etanercept or infliximab prior to 1 March 2007 is deemed to have commenced their first treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) an ESR or CRP measurement reduced by at least 20% from baseline; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the patient commenced treatment with etanercept prior to 1 July 2004, was commenced on PBS‑subsidised treatment prior to 1 March 2007 and is continuing to receive PBS‑subsidised treatment in their first treatment cycle, and where pre‑treatment baselines are not available, response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS‑subsidised treatment, or no greater than 2, and 1 of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) an ESR measurement no greater than 25 mm per hour; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a CRP measurement no greater than 10 mg per L; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all measurements provided are no more than 1 month old at the time of application; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured and supplied for all subsequent continuing treatment applications for the patient; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (b) (i) if the course of therapy is a 16 week initial course, the assessment of response is made following a minimum of 12 weeks of treatment; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (ii) if the course of therapy is a 6 week initial course approved prior to 1 March 2007, the assessment of response is made following at least 4 weeks of treatment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| the application for authorisation includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes a completed BASDAI Assessment Form with certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre‑filled syringes, 4 |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have severe active psoriatic arthritis; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with methotrexate or sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have not failed treatment with etanercept during the current Treatment Cycle; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre‑filled syringes, 4 |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: | Injection | 1 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) were receiving treatment with etanercept prior to 17 March 2005; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the course of treatment is limited to a maximum of 24 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients are eligible for PBS-subsidised treatment under the above criteria once only |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) who have a documented history of severe active psoriatic arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where biological agent means adalimumab or etanercept or infliximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre‑filled syringes, 4 |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: | Injection | 1 | 3 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) have severe active rheumatoid arthritis; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) have not previously received PBS‑subsidised treatment with a bDMARD for this condition, or, where the patient has previously received PBS‑subsidised treatment with a bDMARD for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised bDMARD treatment for this condition was approved; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non‑biological disease modifying anti‑rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS‑subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non‑biological DMARD, at an adequate dose, for a minimum of 3 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response to the treatment regimens specified at (c) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| all tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if intolerance to treatment with the regimens specified at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a signed patient acknowledgment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment in a bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (a) have a documented history of severe active rheumatoid arthritis; and |
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|
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| (b) have received prior PBS‑subsidised treatment with a bDMARD for this condition in this Treatment Cycle and are eligible to receive further bDMARD therapy within this Treatment Cycle; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (c) have not failed previous PBS‑subsidised treatment with etanercept during this Treatment Cycle; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
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|
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| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD Treatment Cycle with that therapy; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| patients are eligible to receive further bDMARD therapy within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 bDMARDs within this Treatment Cycle; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| patients who have previously commenced, and subsequently ceased, PBS‑subsidised treatment with etanercept within this bDMARD Treatment Cycle are eligible to recommence therapy with this drug within this same cycle provided that: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS‑subsidised treatment of rheumatoid arthritis, to their most recent course of PBS‑subsidised etanercept treatment; and |
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| (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and |
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| (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS‑subsidised treatment was a 16‑week initial treatment course; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; |
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|
|
| patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and, in the case of patients recommencing therapy with etanercept in this Treatment Cycle, evidence of the patient's response to their most recent course of PBS‑subsidised etanercept therapy; |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS‑subsidised treatment; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti‑rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above‑mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C‑reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C‑reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injections 50 mg in 1 mL single use pre‑filled syringes, 4 |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing biological disease modifying anti‑rheumatic drug (bDMARD) Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: | Injection | 1 | 5 | Enbrel | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) who have a documented history of severe active rheumatoid arthritis; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) who have demonstrated an adequate response to treatment with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) whose most recent course of PBS‑subsidised bDMARD treatment in this bDMARD Treatment Cycle was with etanercept; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where bDMARD means abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where a bDMARD Treatment Cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who commenced PBS‑subsidised bDMARD treatment prior to 1 March 2008 are deemed to have commenced their first bDMARD treatment cycle with that therapy; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient will be deemed to have failed to respond to treatment with a course of PBS‑subsidised therapy, despite demonstrating a response as defined above, unless: |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) if the course of therapy is a 16‑week initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| if the most recent course of etanercept therapy was a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the patient has not failed to demonstrate response to a course of PBS‑subsidised etanercept in this Treatment Cycle; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment within an ongoing bDMARD Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS‑subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS‑subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS‑subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS‑subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS‑subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — elbow, wrist, knee or ankle (assessed as swollen and tender); |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| authority applications for re‑treatment with etanercept following a break in PBS‑subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Famciclovir | Tablet 250 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash | Oral | 21 | .. | Famvir | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 250 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 56 | 5 | Famvir | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 500 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 56 | 5 | Famvir | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Episodic treatment of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 500 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 150 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and other opportunistic infections or Acquired Immunodeficiency Syndrome defining tumours, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Fentanyl | Transdermal patch 2.1 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 12 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Transdermal patch 4.2 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 25 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Transdermal patch 8.4 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 50 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Transdermal patch 12.6 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 75 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Transdermal patch 16.8 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Transdermal | 10 | .. | Durogesic 100 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Granisetron | Tablet 2 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 5 | 1 | Kytril | ||||||||||||||||||||||||||||||||||||||||||||||||
| Concentrated injection 3 mg (as hydrochloride) in 3 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Injection | 1 | .. | Kytril | ||||||||||||||||||||||||||||||||||||||||||||||||
Hydrocortisone | Injection 100 mg (as sodium succinate) with 2 mL solvent |
| For use in a hospital | Injection | 6 | .. | Solu‑Cortef | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 250 mg (as sodium succinate) with 2 mL solvent |
| For use in a hospital | Injection | 6 | .. | Solu‑Cortef | ||||||||||||||||||||||||||||||||||||||||||||||||
Hydromorphone | Tablet containing hydromorphone hydrochloride 2 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Dilaudid | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing hydromorphone hydrochloride 4 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Dilaudid | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing hydromorphone hydrochloride 8 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Dilaudid | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 2 | .. | Dilaudid | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Ibuprofen | Tablet 400 mg |
| Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease | Oral | 90 | 3 | Brufen | ||||||||||||||||||||||||||||||||||||||||||||||||
Imatinib | Tablet 100 mg (as mesylate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 60 | 5 | Glivec | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| treatment under this restriction is limited to a maximum of 18 months of therapy from the date the first application for initial treatment is approved; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia ‑ Supporting Information form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the bcr‑abl transcript in either peripheral blood or bone marrow; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS‑subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the patient is not receiving concomitant PBS‑subsidised interferon alfa therapy |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment of patients who have received initial treatment with imatinib mesylate as a pharmaceutical benefit for the chronic phase of chronic myeloid leukaemia and who have demonstrated either a major cytogenetic response or less than 1% bcr‑abl level in the blood in the preceding 12 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a peripheral blood bcr‑abl level of less than 1% on the international scale (Blood 108: 28‑37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response to PBS‑subsidised treatment with imatinib mesylate is assessed by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with bcr‑abl specific probe; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) quantitative PCR indicating the relative level of bcr‑abl transcript in the peripheral blood using the international scale; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response or peripheral blood bcr‑abl level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response or peripheral blood bcr‑abl level of less than 1% at between 10 and 12 months (at which time patients in whom a major cytogenetic response or peripheral blood bcr‑abl level of less than 1% is demonstrable by 18 months are eligible for a further 12 months of treatment); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood bcr‑abl level of less than 1% has been sustained; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) demonstration of continued response to treatment as evidenced by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of bcr‑abl of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) if the cytogenetic analysis submitted with the application was conducted using FISH with bcr‑abl specific probe because standard karyotyping was not informative, a copy of the non‑informative standard karyotype analysis; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a patient who has previously received PBS‑subsidised treatment with imatinib mesylate and has at any time failed to meet the criteria for continuing treatment of chronic myeloid leukaemia in the chronic phase, is not eligible for PBS‑subsidised re‑treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 60 | 2 | Glivec | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where progress to the accelerated phase is defined by the presence of 1 or more of the following: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) peripheral basophils greater than or equal to 20%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (4) progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (5) karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia ‑ Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where progress to myeloid blast crisis is defined as either: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) extramedullary involvement other than spleen and liver; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia ‑ Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, where the patient has previously received PBS‑subsidised treatment with imatinib mesylate of the accelerated phase of chronic myeloid leukaemia |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, where the patient has previously received PBS‑subsidised treatment with imatinib mesylate of the blast phase of chronic myeloid leukaemia |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 100 mg (as mesylate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment in combination with chemotherapy as induction or consolidation of a newly diagnosed patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR‑ABL; and | Oral | 60 | 2 | Glivec | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application ‑ Supporting Information Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR‑ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of a patient with acute lymphoblastic leukaemia bearing the Philadelphia chromosome or expressing the transcript BCR‑ABL who was previously treated with imatinib mesylate under the Imatinib Compassionate Program and who meets all the PBS criteria; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application ‑ Supporting Information Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR‑ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR‑ABL; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where PBS‑subsidised imatinib mesylate is available with a lifetime maximum of 24 months of therapy for patients with acute lymphoblastic leukaemia |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 30 | 5 | Glivec | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| treatment under this restriction is limited to a maximum of 18 months of therapy from the date the first application for initial treatment is approved; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the application for authorisation includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia ‑ Supporting Information form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (2) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the bcr‑abl transcript in either peripheral blood or bone marrow; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (3) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS‑subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| the patient is not receiving concomitant PBS‑subsidised interferon alfa therapy |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment of patients who have received initial treatment with imatinib mesylate as a pharmaceutical benefit for the chronic phase of chronic myeloid leukaemia and who have demonstrated either a major cytogenetic response or less than 1% bcr‑abl level in the blood in the preceding 12 months; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the following conditions apply: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| a peripheral blood bcr‑abl level of less than 1% on the international scale (Blood 108: 28‑37, 2006) indicates a response, at least the biological equivalent of a major cytogenetic response; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| response to PBS‑subsidised treatment with imatinib mesylate is assessed by: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (1) cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or, in the case where standard karyotyping is not informative for technical reasons, cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with bcr‑abl specific probe; or |
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| (2) quantitative PCR indicating the relative level of bcr‑abl transcript in the peripheral blood using the international scale; |
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| the cytogenetic or peripheral blood quantitative PCR analyses demonstrating response are submitted as follows: |
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| (i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response or peripheral blood bcr‑abl level of less than 1% has been demonstrated are eligible for a further 12 months of treatment; and |
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| (ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response or peripheral blood bcr‑abl level of less than 1% at between 10 and 12 months (at which time patients in whom a major cytogenetic response or peripheral blood bcr‑abl level of less than 1% is demonstrable by 18 months are eligible for a further 12 months of treatment); and |
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| (iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood bcr‑abl level of less than 1% has been sustained; |
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| the authority application includes: |
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| (1) demonstration of continued response to treatment as evidenced by: |
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| (a) a copy of the cytogenetic analysis showing a major cytogenetic response, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; or |
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| (b) a copy of the quantitative PCR analysis showing a peripheral blood level of bcr‑abl of less than 1% on the international scale, unless the relevant pathology report has been supplied within the previous 12 months, in which case only the date of this report need be provided; and |
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| (2) if the cytogenetic analysis submitted with the application was conducted using FISH with bcr‑abl specific probe because standard karyotyping was not informative, a copy of the non‑informative standard karyotype analysis; |
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| a patient who has previously received PBS‑subsidised treatment with imatinib mesylate and has at any time failed to meet the criteria for continuing treatment of chronic myeloid leukaemia in the chronic phase, is not eligible for PBS‑subsidised re‑treatment |
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| Tablet 400 mg (as mesylate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and | Oral | 30 | 2 | Glivec | ||||||||||||||||||||||||||||||||||||||||||||||||
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| where progress to the accelerated phase is defined by the presence of 1 or more of the following: |
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| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or |
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| (2) percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or |
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| (3) peripheral basophils greater than or equal to 20%; or |
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| (4) progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (5) karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome); and |
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| where the application for authorisation includes: |
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| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia ‑ Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
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| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Treatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia; and |
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| where progress to myeloid blast crisis is defined as either: |
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| (1) percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| (2) extramedullary involvement other than spleen and liver; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| where the application for authorisation includes: |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia ‑ Supporting Information form, stating which of the above criteria are satisfied by the patient; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (b) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, where the patient has previously received PBS‑subsidised treatment with imatinib mesylate of the accelerated phase of chronic myeloid leukaemia |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr‑abl tyrosine kinase, where the patient has previously received PBS‑subsidised treatment with imatinib mesylate of the blast phase of chronic myeloid leukaemia |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 400 mg (as mesylate) |
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment in combination with chemotherapy as induction or consolidation of a newly diagnosed patient with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR‑ABL; and | Oral | 30 | 2 | Glivec | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application ‑ Supporting Information Form; and |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR‑ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment of a patient with acute lymphoblastic leukaemia bearing the Philadelphia chromosome or expressing the transcript BCR‑ABL who was previously treated with imatinib mesylate under the Imatinib Compassionate Program and who meets all the PBS criteria; and |
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|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where the authority application includes: |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) a completed copy of the appropriate Acute Lymphoblastic Leukaemia Imatinib PBS Authority Application ‑ Supporting Information Form; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR‑ABL transcript in either peripheral blood or bone marrow, along with the date of the relevant report; and |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) a signed patient acknowledgement |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment in combination with chemotherapy as maintenance of first complete remission of patients with acute lymphoblastic leukaemia (ALL) bearing the Philadelphia chromosome or expressing the transcript, BCR‑ABL; |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| where PBS‑subsidised imatinib mesylate is available with a lifetime maximum of 24 months of therapy for patients with acute lymphoblastic leukaemia |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Interferon Alfa‑2a | Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non‑Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy | Injection | 15 | 5 | Roferon‑A | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 4,500,000 I.U. in 0.5 mL single dose pre‑filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non‑Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy | Injection | 5 | 5 | Roferon‑A | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 6,000,000 I.U. in 0.5 mL single dose pre‑filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non‑Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy | Injection | 5 | 5 | Roferon‑A | ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection 9,000,000 I.U. in 0.5 mL single dose pre‑filled syringe |
| In compliance with authority procedures set out in subparagraph 11 (d): Low grade non‑Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy | Injection | 5 | 5 | Roferon‑A | ||||||||||||||||||||||||||||||||||||||||||||||||
Interferon Alfa‑2b | Solution for injection 18,000,000 I.U. in 1.2 mL multi‑dose injection pen |
| In compliance with authority procedures set out in subparagraph 11 (d): Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy Low grade non‑Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline‑based chemotherapy | Injection | 3 | 5 | Intron A Redipen | ||||||||||||||||||||||||||||||||||||||||||||||||
Ketoconazole | Tablet 200 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Oral candidiasis in severely immunocompromised persons where topical therapy has failed Systemic or deep mycoses where other forms of therapy have failed | Oral | 30 | 5 | Nizoral | ||||||||||||||||||||||||||||||||||||||||||||||||
Lansoprazole | Capsule 30 mg |
| Gastro‑oesophageal reflux disease Scleroderma oesophagus | Oral | 30 | 5 | Zoton | ||||||||||||||||||||||||||||||||||||||||||||||||
| Sachet containing granules for oral suspension, 30 mg per sachet |
| Gastro‑oesophageal reflux disease Scleroderma oesophagus | Oral | 28 | 5 | Zoton | ||||||||||||||||||||||||||||||||||||||||||||||||
| Sachet containing granules for oral suspension, 30 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor | Oral | 28 | 1 | Zoton | ||||||||||||||||||||||||||||||||||||||||||||||||
| Sachet containing granules for oral suspension, 30 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Gastro‑oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor | Oral | 28 | 5 | Zoton | ||||||||||||||||||||||||||||||||||||||||||||||||
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base‑priced drugs | Oral | 30 | 5 | Zanidip | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base‑priced drugs |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base‑priced drugs |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Transfer to a base‑priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing lercanidipine hydrochloride 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base‑priced drugs | Oral | 30 | 5 | Zanidip | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Drug interactions occurring with all of the base‑priced drugs |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Drug interactions expected to occur with all of the base‑priced drugs |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Transfer to a base‑priced drug would cause patient confusion resulting in problems with compliance |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Levetiracetam | Tablet 250 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | Oral | 60 | 5 | Keppra | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 500 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | Oral | 60 | 5 | Keppra | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 1 g |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | Oral | 60 | 5 | Keppra | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti‑epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Medroxyprogesterone | Tablet containing medroxyprogesterone acetate 10 mg |
| Endometriosis | Oral | 100 | 2 | Provera Ralovera | ||||||||||||||||||||||||||||||||||||||||||||||||
Methadone | Tablet containing methadone hydrochloride 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Physeptone | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Injection containing methadone hydrochloride 10 mg in 1 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Injection | 10 | .. | Physeptone | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Methotrexate | Tablet 10 mg |
| For patients requiring doses greater than 20 mg per week | Oral | 50 | 2 | Methoblastin | ||||||||||||||||||||||||||||||||||||||||||||||||
Metronidazole | Tablet 400 mg |
| Treatment of anaerobic infections | Oral | 21 | 1 | Flagyl Metrogyl 400 Metronide 400 | ||||||||||||||||||||||||||||||||||||||||||||||||
Milk powder — lactose free formula | Oral powder 900 g (S‑26 LF) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proven chronic lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by: | Oral | 5 | 5 | S‑26 LF | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re‑emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) hydrogen breath test |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral powder 900 g (Karicare De‑Lact) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proven chronic lactose intolerance in infants up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by: | Oral | 5 | 5 | Karicare De‑Lact | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re‑emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| (c) hydrogen breath test |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Milk powder — lactose modified | Oral powder 900 g (Digestelact) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven by: | Oral | 3 | 10 | Digestelact | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (a) relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re‑emergence of symptoms on rechallenge with lactose containing formulae or milk or food; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (b) not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet; or |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| (c) hydrogen breath test |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Morphine | Tablet containing morphine sulfate 30 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Anamorph | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
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|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 5 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
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|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 10 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 15 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 30 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 60 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing morphine sulfate 100 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 10 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Kapanol | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Kapanol | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 30 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Kapanol | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 60 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 90 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Kapanol | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing morphine sulfate 120 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 20 | .. | MS Mono | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin Suspension 20 mg | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin Suspension 30 mg | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin Suspension 60 mg | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | MS Contin Suspension 100 mg | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 2 | .. | Ordine 2 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
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| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
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| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 2 | .. | Ordine 5 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
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| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 2 | .. | Ordine 10 | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
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| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
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| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
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Naratriptan | Tablet 2.5 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS‑listed drugs | Oral | 4 | 5 | Naramig | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS‑listed drugs |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS‑listed drugs |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS‑listed drug would cause patient confusion resulting in problems with compliance |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS‑listed drug is likely to result in adverse clinical consequences |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Nifedipine | Tablet 20 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base‑priced drugs | Oral | 30 | 5 | Adalat Oros 20mg | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Drug interactions occurring with all of the base‑priced drugs |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug interactions expected to occur with all of the base‑priced drugs |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
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| Transfer to a base‑priced drug would cause patient confusion resulting in problems with compliance |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Nitrazepam | Tablet 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Myoclonic epilepsy | Oral | 50 | 5 | Alodorm Mogadon | ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Malignant neoplasia (late stage) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| For use by patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
|
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| For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Omeprazole | Tablet 20 mg (as magnesium) |
| Gastro‑oesophageal reflux disease Scleroderma oesophagus Zollinger‑Ellison syndrome | Oral | 30 | 5 | Acimax Tablets Losec Tablets Omepral | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 20 mg |
| Gastro‑oesophageal reflux disease Scleroderma oesophagus Zollinger‑Ellison syndrome | Oral | 30 | 5 | GenRx Omeprazole Meprazol Omeprazole‑GA Omeprazole Winthrop | ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule 20 mg |
| Gastro‑oesophageal reflux disease Scleroderma oesophagus Zollinger‑Ellison syndrome | Oral | 30 | 5 | Probitor | ||||||||||||||||||||||||||||||||||||||||||||||||
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| ||||||||||||||||||||||||||||||||||||||||||||||||
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | Ondansetron‑RL Ondaz Onsetron 4 Zofran | ||||||||||||||||||||||||||||||||||||||||||||||||
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| |||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 8 mg (as hydrochloride dihydrate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | Ondansetron‑RL Ondaz Onsetron 8 Zofran | ||||||||||||||||||||||||||||||||||||||||||||||||
| Wafer 4 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | Ondansetron‑RL Zydis Ondaz Zydis Zofran Zydis | ||||||||||||||||||||||||||||||||||||||||||||||||
| Wafer 8 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Oral | 10 | 1 | Ondansetron‑RL Zydis Ondaz Zydis Zofran Zydis | ||||||||||||||||||||||||||||||||||||||||||||||||
| I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Injection | 1 | .. | Ondansetron‑RL Ondaz Onsetron Pfizer Australia Pty Ltd Zofran | ||||||||||||||||||||||||||||||||||||||||||||||||
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| |||||||||||||||||||||||||||||||||||||||||||||||||
| I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | Injection | 1 | .. | Ondansetron‑RL Ondaz Onsetron Pfizer Australia Pty Ltd Zofran | ||||||||||||||||||||||||||||||||||||||||||||||||
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|
| |||||||||||||||||||||||||||||||||||||||||||||||||
Oxazepam | Tablet 15 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Malignant neoplasia (late stage) | Oral | 50 | 5 | Alepam 15 Serepax | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| For use by patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 30 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Malignant neoplasia (late stage) | Oral | 50 | 5 | Alepam 30 Murelax Serepax | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| For use by patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
Oxycodone | Tablet containing oxycodone hydrochloride 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | Endone | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing oxycodone hydrochloride 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyNorm | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing oxycodone hydrochloride 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyNorm | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule containing oxycodone hydrochloride 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyNorm | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Oral | 2 | .. | OxyNorm Liquid 5mg/5mL | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 5 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 10 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 20 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 40 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing oxycodone hydrochloride 80 mg (controlled release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia | Oral | 40 | .. | OxyContin | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Suppository 30 mg (as pectinate) |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia | Rectal | 24 | .. | Proladone | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Chronic severe disabling pain not responding to non‑narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Initial treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
|
|
| Continuing treatment of chronic severe disabling pain not responding to non‑narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non‑narcotic analgesics |
|
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Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) |
| Gastro‑oesophageal reflux disease Scleroderma oesophagus Zollinger‑Ellison syndrome | Oral | 30 | 5 | Somac | ||||||||||||||||||||||||||||||||||||||||||||||||
Paracetamol | Tablet 500 mg |
| Chronic arthropathies | Oral | 300 | 4 | Chem mart Chemadol | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Dymadon P | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Parahexal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Terry White Chemists Paracetamol | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Tylenol | ||||||||||||||||||||||||||||||||||||||||||||||||
Phenoxymethyl‑penicillin | Tablet 250 mg phenoxymethyl‑ penicillin (as potassium) |
| Prophylaxis of recurrent streptococcal infections (including rheumatic fever) | Oral | 50 | 5 | Abbocillin‑VK Filmtab | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Capsule 250 mg phenoxymethylpenicillin (as potassium) |
| Prophylaxis of recurrent streptococcal infections (including rheumatic fever) | Oral | 50 | 5 | Cilicaine VK Cilopen VK LPV Penhexal VK | ||||||||||||||||||||||||||||||||||||||||||||||||
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Rabeprazole | Tablet containing rabeprazole sodium 20 mg (enteric coated) |
| Gastro‑oesophageal reflux disease Scleroderma oesophagus | Oral | 30 | 5 | Pariet | ||||||||||||||||||||||||||||||||||||||||||||||||
Ranitidine | Tablet, effervescent, 150 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base‑priced drugs | Oral | 60 | 5 | Zantac | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug interactions occurring with all of the base‑priced drugs |
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| Drug interactions expected to occur with all of the base‑priced drugs |
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| Transfer to a base‑priced drug would cause patient confusion resulting in problems with compliance |
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| Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base‑priced drugs | Oral | 2 | 5 | Zantac Syrup | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug interactions occurring with all of the base‑priced drugs |
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| Drug interactions expected to occur with all of the base‑priced drugs |
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| Transfer to a base‑priced drug would cause patient confusion resulting in problems with compliance |
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Rifampicin | Capsule 150 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Leprosy in adults | Oral | 100 | .. | Rimycin 150 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Capsule 300 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Leprosy in adults | Oral | 100 | .. | Rimycin 300 | ||||||||||||||||||||||||||||||||||||||||||||||||
Risperidone | Tablet 0.5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 60 | 5 | Risperdal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| 1589 | Schizophrenia |
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| Tablet 0.5 mg (orally disintegrating) |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 56 | 5 | Risperdal Quicklet | ||||||||||||||||||||||||||||||||||||||||||||||||
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| 1589 | Schizophrenia |
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| Tablet 1 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 60 | 5 | Risperdal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| 1589 | Schizophrenia |
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| 2272 | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
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| Tablet 1 mg (orally disintegrating) |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 56 | 5 | Risperdal Quicklet | ||||||||||||||||||||||||||||||||||||||||||||||||
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| 1589 | Schizophrenia |
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| 2272 | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
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| Tablet 2 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 60 | 5 | Risperdal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| 1589 | Schizophrenia |
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| 2272 | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
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| Tablet 2 mg (orally disintegrating) |
| In compliance with authority procedures set out in subparagraph 11 (d): | Oral | 56 | 5 | Risperdal Quicklet | ||||||||||||||||||||||||||||||||||||||||||||||||
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| 1589 | Schizophrenia |
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| 2272 | Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder |
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Rituximab | Solution for I.V. infusion 100 mg in 10 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of previously untreated, CD20 positive, diffuse large B‑cell non‑Hodgkin's lymphoma, in combination with chemotherapy Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B‑cell non‑Hodgkin's lymphoma, in combination with chemotherapy | Injection | 2 | 7 | Mabthera | ||||||||||||||||||||||||||||||||||||||||||||||||
| Solution for I.V. infusion 500 mg in 50 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of previously untreated, CD20 positive, diffuse large B‑cell non‑Hodgkin's lymphoma, in combination with chemotherapy Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B‑cell non‑Hodgkin's lymphoma, in combination with chemotherapy | Injection | 1 | 7 | Mabthera | ||||||||||||||||||||||||||||||||||||||||||||||||
Sertraline | Tablet 50 mg (as hydrochloride) |
| Obsessive‑compulsive disorder Panic disorder where other treatments have failed or are inappropriate | Oral | 30 | 5 | Eleva 50 Xydep 50 Zoloft | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 100 mg (as hydrochloride) |
| Obsessive‑compulsive disorder Panic disorder where other treatments have failed or are inappropriate | Oral | 30 | 5 | Eleva 100 Xydep 100 Zoloft | ||||||||||||||||||||||||||||||||||||||||||||||||
Temazepam | Tablet 10 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Malignant neoplasia (late stage) | Oral | 50 | 5 | Normison Temaze Temtabs | ||||||||||||||||||||||||||||||||||||||||||||||||
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| For use by patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
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| For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal |
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Temozolomide | Capsule 5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Recurrence of anaplastic astrocytoma following standard therapy | Oral | 5 | 5 | Temodal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Recurrence of glioblastoma multiforme following standard therapy |
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| Glioblastoma multiforme following radiotherapy |
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| Capsule 20 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Recurrence of anaplastic astrocytoma following standard therapy | Oral | 5 | 5 | Temodal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Recurrence of glioblastoma multiforme following standard therapy |
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| Glioblastoma multiforme following radiotherapy |
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| Capsule 100 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Recurrence of anaplastic astrocytoma following standard therapy | Oral | 5 | 5 | Temodal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Recurrence of glioblastoma multiforme following standard therapy |
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| Glioblastoma multiforme following radiotherapy |
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Terbinafine | Tablet 250 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed, where the infection is proven by microscopy or culture and confirmed by an Approved Pathology Authority not more than 12 months prior to the date of the authority application and where the date of the pathology report is included in the authority application | Oral | 42 | 1 | GenRx Terbinafine Lamisil Tamsil Terbihexal Terbinafine 250 Terbinafine‑DP Zabel | ||||||||||||||||||||||||||||||||||||||||||||||||
Tramadol | Capsule containing tramadol hydrochloride 50 mg |
| For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed | Oral | 20 | 2 | Chem mart Tramadol | ||||||||||||||||||||||||||||||||||||||||||||||||
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| GenRx Tramadol | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Terry White Chemists Tramadol | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Tramal | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Tramedo | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Zydol | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing tramadol hydrochloride 50 mg (sustained release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non‑narcotic analgesics | Oral | 40 | .. | Tramal SR 50 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing tramadol hydrochloride 100 mg (sustained release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non‑narcotic analgesics | Oral | 40 | .. | Tramahexal SR Tramal SR 100 Tramedo SR 100Zydol SR 100 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing tramadol hydrochloride 150 mg (sustained release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non‑narcotic analgesics | Oral | 40 | .. | Tramahexal SR Tramal SR 150 Tramedo SR 150 Zydol SR 150 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet containing tramadol hydrochloride 200 mg (sustained release) |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non‑narcotic analgesics | Oral | 40 | .. | Tramahexal SR Tramal SR 200 Tramedo SR 200 Zydol SR 200 | ||||||||||||||||||||||||||||||||||||||||||||||||
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL |
| In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non‑narcotic analgesics | Oral | 2 | .. | Tramal | ||||||||||||||||||||||||||||||||||||||||||||||||
Valaciclovir | Tablet 500 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | Oral | 30 | 5 | Valtrex | ||||||||||||||||||||||||||||||||||||||||||||||||
| Tablet 500 mg (as hydrochloride) |
| In compliance with authority procedures set out in subparagraph 11 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash Herpes zoster ophthalmicus | Oral | 42 | .. | Valtrex | ||||||||||||||||||||||||||||||||||||||||||||||||
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) |
| Endophthalmitis Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic | Injection | 5 | .. | Hospira Pty Limited Vancocin CP Vancomycin Sandoz | ||||||||||||||||||||||||||||||||||||||||||||||||
| Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) |
| Endophthalmitis Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic | Injection | 3 | .. | Hospira Pty Limited Vancomycin Sandoz | ||||||||||||||||||||||||||||||||||||||||||||||||
Zolmitriptan | Tablet 2.5 mg |
| In compliance with authority procedures set out in subparagraph 11 (d): Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where adverse events have occurred with other suitable PBS‑listed drugs | Oral | 4 | 5 | Zomig | ||||||||||||||||||||||||||||||||||||||||||||||||
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|
| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions have occurred with other suitable PBS‑listed drugs |
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| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where drug interactions are expected to occur with other suitable PBS‑listed drugs |
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| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS‑listed drug would cause patient confusion resulting in problems with compliance |
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| Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated, and where transfer to another suitable PBS‑listed drug is likely to result in adverse clinical consequences |
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Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | Oral application | 1 | .. | Difflam |
Bisacodyl | Tablet 5 mg | Oral | 200 | .. | Bisalax Lax‑Tab |
| Suppositories 10 mg, 10 | Rectal | 3 | .. | Dulcolax Petrus Bisacodyl Suppositories |
| Suppositories 10 mg, 12 | Rectal | 3 | .. | Fleet Laxative Suppositories Petrus Bisacodyl Suppositories |
| Enemas 10 mg in 5 mL, 25 | Rectal | 1 | .. | Bisalax |
Carmellose | Mouth spray containing carmellose sodium 10 mg per mL, 25 mL | Oral application | 1 | .. | Aquae |
| Mouth spray containing carmellose sodium 10 mg per mL, 100 mL | Oral application | 1 | .. | Aquae |
Clonazepam | Tablet 500 micrograms | Oral | 100 | .. | Paxam 0.5 Rivotril |
| Tablet 2 mg | Oral | 100 | .. | Paxam 2 Rivotril |
| Oral liquid 2.5 mg per mL, 10 mL | Oral | 2 | .. | Rivotril |
Diazepam | Tablet 2 mg | Oral | 50 | .. | Antenex 2 |
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| Ducene |
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| Valium |
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| Valpam 2 |
| Tablet 5 mg | Oral | 50 | .. | Antenex 5 |
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| Diazepam‑DP |
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| Ducene |
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| Valium |
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| Valpam 5 |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Oral | 100 | .. | Chem mart Diclofenac |
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| Clonac 25 |
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| Diclohexal |
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| Dinac |
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| Fenac 25 |
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| GenRx Diclofenac |
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| Terry White Chemists Diclofenac |
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| Voltaren 25 |
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Oral | 50 | .. | Chem mart Diclofenac |
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| Clonac 50 |
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| Diclohexal |
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| Dinac |
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| Fenac |
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| GenRx Diclofenac |
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| Terry White Chemists Diclofenac |
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| Voltaren 50 |
| Suppository containing diclofenac sodium 100 mg | Rectal | 40 | .. | Voltaren 100 |
Fentanyl | Lozenges 200 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | Buccal | 3 | .. | Actiq |
Glycerol | Suppositories 700 mg, 12 | Rectal | 3 | .. | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 1.4 g, 12 | Rectal | 3 | .. | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 2.8 g, 12 | Rectal | 3 | .. | Petrus Pharmaceuticals Pty Ltd |
Hyoscine | Injection containing hyoscine butylbromide 20 mg in 1 mL | Injection | 5 | .. | Buscopan |
Ibuprofen | Tablet 200 mg | Oral | 100 | .. | Rafen 200 |
| Tablet 400 mg | Oral | 90 | .. | Brufen |
Indomethacin | Capsule 25 mg | Oral | 100 | .. | Arthrexin Indocid |
| Suppository 100 mg | Rectal | 40 | .. | Indocid |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | Oral | 1 | .. | Actilax |
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| Duphalac |
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| Genlac |
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| GenRx Lactulose |
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| Lac‑Dol |
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| Lactocur |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | Oral | 1 | .. | Movicol |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL | Oral | 1 | .. | GlaxoSmithKline Australia Pty Ltd |
Morphine | Tablet containing morphine sulfate 10 mg | Oral | 20 | .. | Sevredol |
| Tablet containing morphine sulfate 20 mg | Oral | 20 | .. | Sevredol |
| Tablet containing morphine sulfate 200 mg (controlled release) | Oral | 20 | .. | MS Contin |
Naproxen | Tablet containing naproxen sodium 550 mg | Oral | 50 | .. | Anaprox 550 Crysanal |
| Tablet 250 mg | Oral | 100 | .. | Inza 250 Naprosyn |
| Tablet 500 mg | Oral | 50 | .. | Inza 500 Naprosyn |
| Tablet 750 mg (sustained release) | Oral | 28 | .. | Naprosyn SR750 Proxen SR 750 |
| Tablet 1 g (sustained release) | Oral | 28 | .. | Naprosyn SR1000 Proxen SR 1000 |
| Oral suspension 125 mg per 5 mL, 474 mL | Oral | 1 | .. | Naprosyn |
Nitrazepam | Tablet 5 mg | Oral | 50 | .. | Alodorm Mogadon |
Oxazepam | Tablet 15 mg | Oral | 50 | .. | Alepam 15 Serepax |
| Tablet 30 mg | Oral | 50 | .. | Alepam 30 Murelax Serepax |
Paracetamol | Tablet 665 mg (modified release) | Oral | 192 | .. | Panadol Osteo |
| Suppositories 500 mg, 24 | Rectal | 1 | .. | Panadol |
Promethazine | Tablet containing promethazine hydrochloride 10 mg | Oral | 50 | .. | Phenergan |
| Tablet containing promethazine hydrochloride 25 mg | Oral | 50 | .. | Phenergan |
| Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL | Oral | 1 | .. | Phenergan |
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | Enemas 3.125 g‑450 mg‑45 mg in 5 mL, 12 | Rectal | 2 | .. | Microlax |
Sterculia with Frangula Bark | Granules 620 mg‑80 mg per g, 500 g | Oral | 1 | .. | Normacol Plus |
Sulindac | Tablet 100 mg | Oral | 100 | .. | Aclin |
| Tablet 200 mg | Oral | 50 | .. | Aclin 200 |
Temazepam | Tablet 10 mg | Oral | 50 | .. | Normison Temaze Temtabs |
Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where a painful mouth is a problem Continuing supply for palliative care patients where a painful mouth is a problem, and where consultation with a palliative care specialist or service has occurred | Oral application | 1 | 3 | Difflam |
Bisacodyl | Tablet 5 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 200 | 3 | Bisalax Lax‑Tab |
| Suppositories 10 mg, 10 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Dulcolax Petrus Bisacodyl Suppositories |
| Suppositories 10 mg, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Fleet Laxative Suppositories Petrus Bisacodyl Suppositories |
| Enemas 10 mg in 5 mL, 25 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 1 | 3 | Bisalax |
Carmellose | Mouth spray containing carmellose sodium 10 mg per mL, 25 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred | Oral application | 1 | 3 | Aquae |
| Mouth spray containing carmellose sodium 10 mg per mL, 100 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred | Oral application | 1 | 3 | Aquae |
Clonazepam | Tablet 500 micrograms | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Paxam 0.5 Rivotril |
| Tablet 2 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Paxam 2 Rivotril |
| Oral liquid 2.5 mg per mL, 10 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred | Oral | 2 | 3 | Rivotril |
Diazepam | Tablet 2 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Antenex 2 Ducene Valium Valpam 2 |
| Tablet 5 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Antenex 5 Diazepam‑DP Ducene Valium Valpam 5 |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Chem mart Diclofenac Clonac 25 Diclohexal Dinac Fenac 25 GenRx Diclofenac Terry White Chemists Diclofenac Voltaren 25 |
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| Tablet (enteric coated) containing diclofenac sodium 50 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Chem mart Diclofenac Clonac 50 Diclohexal Dinac Fenac GenRx Diclofenac Terry White Chemists Diclofenac Voltaren 50 |
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| Suppository containing diclofenac sodium 100 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 40 | 3 | Voltaren 100 |
Fentanyl | Lozenges 200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 400 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 800 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 1200 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): First continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Second and subsequent continuing supply, for up to 3 months, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects, where consultation with a palliative care specialist or service has occurred | Buccal | 20 | 2 | Actiq |
| Lozenges 1600 micrograms (as citrate), 3 | In compliance with authority procedures set out in subparagraph 11 (d): Second and subsequent continuing supply, for up to 1 month, for breakthrough pain in palliative care patients with cancer who are receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects | Buccal | 20 | .. | Actiq |
Glycerol | Suppositories 700 mg, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 1.4 g, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Petrus Pharmaceuticals Pty Ltd |
| Suppositories 2.8 g, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 3 | 3 | Petrus Pharmaceuticals Pty Ltd |
Hyoscine | Injection containing hyoscine butylbromide 20 mg in 1 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom Continuing supply for palliative care patients where colicky pain is a symptom, and where consultation with a palliative care specialist or service has occurred | Injection | 5 | 3 | Buscopan |
Ibuprofen | Tablet 200 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Rafen 200 |
| Tablet 400 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 90 | 3 | Brufen |
Indomethacin | Capsule 25 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Arthrexin Indocid |
| Suppository 100 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 40 | 3 | Indocid |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Actilax Duphalac Genlac GenRx Lactulose Lac‑Dol Lactocur |
Macrogol 3350 | Sachets containing powder for oral solution 13.125 g with electrolytes, 30 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Movicol |
Methadone | Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 2 | GlaxoSmithKline Australia Pty Ltd |
Morphine | Tablet containing morphine sulfate 10 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non‑narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non‑narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 20 | 2 | Sevredol |
| Tablet containing morphine sulfate 20 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non‑narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non‑narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 20 | 2 | Sevredol |
| Tablet containing morphine sulfate 200 mg (controlled release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non‑narcotic analgesics, and where consultation with a palliative care specialist or service has occurred | Oral | 20 | 2 | MS Contin |
Naproxen | Tablet 250 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Inza 250 Naprosyn |
| Tablet containing naproxen sodium 550 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Anaprox 550 Crysanal |
| Tablet 500 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Inza 500 Naprosyn |
| Tablet 750 mg (sustained release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 28 | 3 | Naprosyn SR750 Proxen SR 750 |
| Tablet 1 g (sustained release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 28 | 3 | Naprosyn SR1000 Proxen SR 1000 |
| Oral suspension 125 mg per 5 mL, 474 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non‑steroidal anti‑inflammatory agent Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non‑steroidal anti‑inflammatory agent, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Naprosyn |
Nitrazepam | Tablet 5 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Alodorm Mogadon |
Oxazepam | Tablet 15 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Alepam 15 Serepax |
| Tablet 30 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Alepam 30 Murelax Serepax |
Paracetamol | Tablet 665 mg (modified release) | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred | Oral | 192 | 3 | Panadol Osteo |
| Suppositories 500 mg, 24 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred | Rectal | 1 | 3 | Panadol |
Promethazine | Tablet containing promethazine hydrochloride 10 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Phenergan |
| Tablet containing promethazine hydrochloride 25 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Phenergan |
| Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Phenergan |
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | Enemas 3.125 g‑450 mg‑45 mg in 5 mL, 12 | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Rectal | 2 | 3 | Microlax |
Sterculia with Frangula Bark | Granules 620 mg‑80 mg per g, 500 g | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 1 | 3 | Normacol Plus |
Sulindac | Tablet 100 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 100 | 3 | Aclin |
| Tablet 200 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Aclin 200 |
Temazepam | Tablet 10 mg | In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred | Oral | 50 | 3 | Normison Temaze Temtabs |
Adrenaline | Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000) | Injection | 5 | .. | AstraZeneca Pty Ltd | ||||
Amoxycillin | Tablet, chewable, 250 mg (as trihydrate) | Oral | 20 | .. | Amoxil | ||||
| Capsule 250 mg (as trihydrate) | Oral | 20 | .. | Alphamox 250 | ||||
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| Capsule 500 mg (as trihydrate) | Oral | 20 | .. | Alphamox 500 | ||||
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| Sachet containing oral powder 3 g (as trihydrate) | Oral | 1 | .. | Amoxil | ||||
| Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL | Oral | 1 | .. | Amoxil | ||||
| Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | .. | Alphamox 125 | ||||
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| Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | .. | Alphamox 250 Amohexal Amoxil Forte Bgramin Chem mart Amoxycillin Cilamox GenRx Amoxycillin Ranmoxy Terry White Chemists Amoxycillin | ||||
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| Powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL | Oral | 1 | .. | Maxamox | ||||
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | .. | Augmentin Duo Clamohexal Duo 500mg/125mg Clamoxyl Duo Clavulin Duo Curam 500/125 GA‑Amclav 500/125 Moxiclav Duo 500/125 | ||||
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| Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | Oral | 10 | .. | Augmentin Duo forte Chem mart Amoxycillin and Clavulanic Acid Clamohexal Duo Forte 875mg/125mg Clamoxyl Duo forte Clavulin Duo Forte Clavycillin 875/125 Curam 875/125 GA‑Amclav Forte 875/125 GenRx Amoxycillin and Clavulanic Acid Moxiclav Duo Forte 875/125 Terry White Chemists Amoxycillin and Clavulanic Acid | ||||
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| Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL | Oral | 1 | .. | Augmentin Clamohexal 125mg/31.25mg/5mL Clamoxyl Clavulin | ||||
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| Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Oral | 1 | .. | Augmentin Duo 400 Clamohexal Duo 400mg/57mg/5mL Clamoxyl Duo 400 Clavulin Duo 400 | ||||
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Amphotericin | Lozenge 10 mg | Oral | 20 | .. | Fungilin | ||||
Ampicillin | Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Austrapen Ibimicyn | ||||
| Powder for injection 1 g (as sodium) | Injection | 5 | .. | Aspen Ampicyn Austrapen Ibimicyn | ||||
Aspirin | Tablet, dispersible, 300 mg | Oral | 96 | .. | Solprin | ||||
Atropine | Injection containing atropine sulfate 600 micrograms in 1 mL | Injection | 10 | .. | AstraZeneca Pty Ltd | ||||
Benzathine benzylpenicillin | Injection 900 mg in 2.3 mL single use pre‑filled syringe | Injection | 10 | .. | Bicillin L‑A | ||||
Benzathine Penicillin | Powder for injection 900 mg | Injection | 1 | .. | Pan Benzathine Benzylpenicillin | ||||
Benztropine | Injection containing benztropine mesylate 2 mg in 2 mL | Injection | 5 | .. | Cogentin | ||||
Benzydamine | Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL | Oral application | 1 | .. | Difflam | ||||
Benzylpenicillin | Powder for injection 600 mg (as sodium) | Injection | 10 | .. | BenPen | ||||
| Powder for injection 3 g (as sodium) | Injection | 10 | .. | BenPen | ||||
Betamethasone | Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL | Injection | 5 | .. | Celestone Chronodose | ||||
Carbamazepine | Tablet 100 mg | Oral | 200 | .. | Carbamazepine Sandoz Tegretol 100 | ||||
| Tablet 200 mg | Oral | 200 | .. | Carbamazepine Sandoz Tegretol 200 Teril | ||||
| Tablet 200 mg (controlled release) | Oral | 200 | .. | Tegretol CR 200 | ||||
| Tablet 400 mg (controlled release) | Oral | 200 | .. | Tegretol CR 400 | ||||
| Oral suspension 100 mg per 5 mL, 300 mL | Oral | 1 | .. | Tegretol Liquid | ||||
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Oral | 10 | .. | Ceclor CD | ||||
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| Chem mart Cefaclor CD | ||||
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| Douglas Cefaclor‑CD | ||||
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| GenRx Cefaclor CD | ||||
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| Karlor CD | ||||
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| Keflor CD | ||||
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| Ozcef | ||||
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| Terry White Chemists Cefaclor CD | ||||
| Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL | Oral | 1 | .. | Aclor 125 | ||||
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| Ceclor | ||||
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| Cefaclor Sandoz | ||||
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| GenRx Cefaclor | ||||
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| Keflor | ||||
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| Ozcef | ||||
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| Terry White Chemists Cefaclor | ||||
| Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL | Oral | 1 | .. | Aclor 250 | ||||
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| Ceclor | ||||
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| Cefaclor Sandoz | ||||
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| GenRx Cefaclor | ||||
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| Keflor | ||||
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| Ozcef | ||||
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| Terry White Chemists Cefaclor | ||||
Cefotaxime | Powder for injection 1 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited | ||||
| Powder for injection 2 g (as sodium) | Injection | 10 | .. | Cefotaxime Sandoz Hospira Pty Limited | ||||
Cefuroxime | Tablet 250 mg (as axetil) | Oral | 14 | .. | Zinnat | ||||
Cephalexin | Capsule 250 mg (anhydrous) | Oral | 20 | .. | Cephabell Cephalexin Max | ||||
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| Chem mart Cephalexin | ||||
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| Cilex | ||||
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| GenRx Cephalexin | ||||
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| Ialex | ||||
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| Ibilex 250 | ||||
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| Keflex | ||||
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| Rancef | ||||
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| Sporahexal | ||||
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| Terry White Chemists Cephalexin | ||||
| Capsule 500 mg (anhydrous) | Oral | 20 | .. | Cephabell | ||||
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| Cephalexin Max | ||||
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| Chem mart Cephalexin | ||||
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| Cilex | ||||
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| GenRx Cephalexin | ||||
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| Ialex | ||||
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| Ibilex 500 | ||||
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| Keflex | ||||
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| Rancef | ||||
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| Sporahexal | ||||
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| Terry White Chemists Cephalexin | ||||
| Granules for oral suspension 125 mg per 5 mL, 100 mL | Oral | 1 | .. | Cefalexin Sandoz | ||||
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| Chem mart Cephalexin | ||||
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| Cilex | ||||
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| GenRx Cephalexin | ||||
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| Ialex | ||||
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| Ibilex 125 | ||||
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| Keflex | ||||
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| Terry White Chemists Cephalexin | ||||
| Granules for oral suspension 250 mg per 5 mL, 100 mL | Oral | 1 | .. | Cefalexin Sandoz | ||||
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| Chem mart Cephalexin | ||||
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| Cilex | ||||
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| GenRx Cephalexin | ||||
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| Ialex | ||||
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| Ibilex 250 | ||||
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| Keflex | ||||
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| Terry White Chemists Cephalexin | ||||
Cephalothin | Powder for injection 1 g (as sodium) | Injection | 10 | .. | Keflin Neutral Hospira Pty Limited | ||||
Chloramphenicol | Eye drops 5 mg per mL, 10 mL | Application to the eye | 1 | .. | Chloromycetin Chlorsig | ||||
Clindamycin | Capsule 150 mg (as hydrochloride) | Oral | 24 | .. | Cleocin Dalacin C | ||||
Codeine | Tablet containing codeine phosphate 30 mg | Oral | 20 | .. | Fawns and McAllan Proprietary Limited | ||||
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Oral | 20 | .. | Codalgin Forte Codapane Forte Comfarol Forte Dolaforte Panadeine Forte | ||||
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| Prodeine Forte | ||||
Diazepam | Tablet 2 mg | Oral | 50 | .. | Antenex 2 | ||||
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| Ducene | ||||
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| Valium | ||||
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| Valpam 2 | ||||
| Tablet 5 mg | Oral | 50 | .. | Antenex 5 | ||||
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| Ducene | ||||
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| Valium | ||||
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| Valpam 5 | ||||
| Injection 10 mg in 2 mL ampoule | Injection | 5 | .. | Hospira Pty Limited | ||||
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Oral | 100 | .. | Chem mart Diclofenac | ||||
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| Clonac 25 | ||||
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| Diclohexal | ||||
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| Dinac | ||||
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| Fenac 25 | ||||
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| GenRx Diclofenac | ||||
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| Terry White Chemists Diclofenac | ||||
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| Voltaren 25 | ||||
| Tablet (enteric coated) containing diclofenac sodium 50 mg | Oral | 50 | .. | Chem mart Diclofenac | ||||
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| Clonac 50 | ||||
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| Diclohexal | ||||
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| Dinac | ||||
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| Fenac | ||||
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| GenRx Diclofenac | ||||
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| Terry White Chemists Diclofenac | ||||
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| Voltaren 50 | ||||
| Suppository containing diclofenac sodium 100 mg | Rectal | 40 | .. | Voltaren 100 | ||||
Dicloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Diclocil Dicloxsig Distaph 250 | ||||
| Capsule 500 mg (as sodium) | Oral | 24 | .. | Diclocil Dicloxsig Distaph 500 | ||||
| Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Diclocil | ||||
| Powder for injection 1 g (as sodium) | Injection | 5 | .. | Diclocil | ||||
Doxycycline | Tablet 100 mg (as monohydrate) | Oral | 7 | .. | Chem mart Doxycycline | ||||
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| Doxyhexal | ||||
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| GenRx Doxycycline | ||||
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| Terry White Chemists Doxycycline | ||||
| Tablet 100 mg (as hydrochloride) | Oral | 7 | .. | Doxsig | ||||
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| Doxy‑100 | ||||
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| Doxylin 100 | ||||
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| Vibramycin | ||||
| Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) | Oral | 7 | .. | DBL Doxycycline Doryx | ||||
Erythromycin | Tablet 400 mg (as ethyl succinate) | Oral | 25 | .. | E.E.S. 400 Filmtab E‑Mycin | ||||
| Capsule 250 mg (containing enteric coated pellets) | Oral | 25 | .. | DBL Erythromycin Eryc | ||||
| Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | .. | E.E.S. 200 E‑Mycin 200 | ||||
| Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL | Oral | 1 | .. | E.E.S. Granules E‑Mycin 400 | ||||
| Powder for I.V. infusion 1 g (as lactobionate) | Injection | 5 | .. | Erythrocin‑I.V. | ||||
Flucloxacillin | Capsule 250 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 250 | ||||
| Capsule 500 mg (as sodium) | Oral | 24 | .. | Flopen Staphylex 500 | ||||
| Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL | Oral | 1 | .. | Aspen Pharmacare Australia Pty Limited | ||||
| Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL | Oral | 1 | .. | Flopen | ||||
| Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL | Oral | 1 | .. | Aspen Pharmacare Australia Pty Limited | ||||
| Powder for injection 500 mg (as sodium) | Injection | 5 | .. | Flubiclox Flucil | ||||
| Powder for injection 1 g (as sodium) | Injection | 5 | .. | Flubiclox | ||||
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| Flucil | ||||
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| Hospira Pty Limited | ||||
Glucagon | Injection set containing glucagon hydrochloride 1 mg (1 I.U.) and 1 mL solvent in disposable syringe | Injection | 1 | .. | GlucaGen Hypokit | ||||
Glucose | I.V. infusion 278 mmol (anhydrous) per L, 1 L | Injection | 5 | .. | Baxter Healthcare Pty Limited | ||||
Glyceryl Trinitrate | Tablets 600 micrograms, 100 | Buccal/sublingual | 1 | .. | Anginine Stabilised Lycinate | ||||
Hydrocortisone | Injection 100 mg (as sodium succinate) with 2 mL solvent | Injection | 6 | .. | Solu‑Cortef | ||||
| Injection 250 mg (as sodium succinate) with 2 mL solvent | Injection | 6 | .. | Solu‑Cortef | ||||
| Cream containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | .. | Cortic‑DS 1% Sigmacort | ||||
| Cream containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | .. | Cortef Cortic‑DS 1% Sigmacort | ||||
| Ointment containing hydrocortisone acetate 10 mg per g, 30 g | Application | 1 | .. | Cortic‑DS 1% Sigmacort | ||||
| Ointment containing hydrocortisone acetate 10 mg per g, 50 g | Application | 1 | .. | Cortic‑DS 1% Sigmacort | ||||
Hydromorphone | Tablet containing hydromorphone hydrochloride 2 mg | Oral | 20 | .. | Dilaudid | ||||
| Tablet containing hydromorphone hydrochloride 4 mg | Oral | 20 | .. | Dilaudid | ||||
| Tablet containing hydromorphone hydrochloride 8 mg | Oral | 20 | .. | Dilaudid | ||||
| Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 473 mL | Oral | 1 | .. | Dilaudid | ||||
| Injection containing hydromorphone hydrochloride 2 mg in 1 mL | Injection | 5 | .. | Dilaudid | ||||
| Injection containing hydromorphone hydrochloride 10 mg in 1 mL | Injection | 5 | .. | Dilaudid‑HP | ||||
| Injection containing hydromorphone hydrochloride 50 mg in 5 mL | Injection | 5 | .. | Dilaudid‑HP | ||||
Ibuprofen | Tablet 200 mg | Oral | 100 | .. | Rafen 200 | ||||
| Tablet 400 mg | Oral | 30 | .. | Brufen | ||||
Indomethacin | Capsule 25 mg | Oral | 100 | .. | Arthrexin Indocid | ||||
| Suppository 100 mg | Rectal | 40 | .. | Indocid | ||||
Ketoprofen | Capsule 200 mg (sustained release) | Oral | 28 | .. | Orudis SR 200 Oruvail SR | ||||
| Suppository 100 mg | Rectal | 40 | .. | Orudis | ||||
Lignocaine | Injection containing lignocaine hydrochloride 100 mg in 5 mL | Injection | 5 | .. | Pfizer Australia Pty Ltd | ||||
Lincomycin | Injection 600 mg (as hydrochloride) in 2 mL | Injection | 5 | .. | Lincocin | ||||
Methylprednisolone | Injection containing methylprednisolone acetate 40 mg in 1 mL | Injection | 5 | .. | Depo‑Medrol Depo‑Nisolone | ||||
Metoclopramide | Tablet containing metoclopramide hydrochloride 10 mg | Oral | 25 | .. | Maxolon Pramin | ||||
| Injection containing metoclopramide hydrochloride 10 mg in 2 mL | Injection | 10 | .. | Maxolon | ||||
Metronidazole | Tablet 200 mg | Oral | 21 | .. | Flagyl Metrogyl 200 Metronide 200 | ||||
| Tablet 400 mg | Oral | 5 | .. | Metrogyl 400 | ||||
| Oral suspension containing metronidazole benzoate 320 mg per 5 mL, 100 mL | Oral | 1 | .. | Flagyl S | ||||
| I.V. infusion 500 mg in 100 mL | Injection | 5 | .. | Baxter Healthcare Pty Limited DBL Metronidazole Intravenous Infusion Metronidazole Sandoz | ||||
| Suppositories 500 mg, 10 | Rectal | 1 | .. | Flagyl | ||||
Morphine | Tablet containing morphine sulfate 30 mg | Oral | 20 | .. | Anamorph | ||||
| Tablet containing morphine sulfate 5 mg (controlled release) | Oral | 20 | .. | MS Contin | ||||
| Tablet containing morphine sulfate 10 mg (controlled release) | Oral | 20 | .. | MS Contin | ||||
| Tablet containing morphine sulfate 15 mg (controlled release) | Oral | 20 | .. | MS Contin | ||||
| Tablet containing morphine sulfate 30 mg (controlled release) | Oral | 20 | .. | MS Contin | ||||
| Tablet containing morphine sulfate 60 mg (controlled release) | Oral | 20 | .. | MS Contin | ||||
| Tablet containing morphine sulfate 100 mg (controlled release) | Oral | 20 | .. | MS Contin | ||||
| Capsule containing morphine sulfate 10 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | ||||
| Capsule containing morphine sulfate 20 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | ||||
| Capsule containing morphine sulfate 30 mg (controlled release) | Oral | 10 | .. | MS Mono | ||||
| Capsule containing morphine sulfate 50 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | ||||
| Capsule containing morphine sulfate 60 mg (controlled release) | Oral | 10 | .. | MS Mono | ||||
| Capsule containing morphine sulfate 90 mg (controlled release) | Oral | 10 | .. | MS Mono | ||||
| Capsule containing morphine sulfate 100 mg (containing sustained release pellets) | Oral | 20 | .. | Kapanol | ||||
| Capsule containing morphine sulfate 120 mg (controlled release) | Oral | 10 | .. | MS Mono | ||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet | Oral | 20 | .. | MS Contin Suspension 20 mg | ||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet | Oral | 20 | .. | MS Contin Suspension 30 mg | ||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet | Oral | 20 | .. | MS Contin Suspension 60 mg | ||||
| Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet | Oral | 20 | .. | MS Contin Suspension 100 mg | ||||
| Oral solution containing morphine hydrochloride 2 mg per mL, 200 mL | Oral | 1 | .. | Ordine 2 | ||||
| Oral solution containing morphine hydrochloride 5 mg per mL, 200 mL | Oral | 1 | .. | Ordine 5 | ||||
| Oral solution containing morphine hydrochloride 10 mg per mL, 200 mL | Oral | 1 | .. | Ordine 10 | ||||
| Injection containing morphine sulfate 10 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited | ||||
| Injection containing morphine sulfate 15 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited | ||||
| Injection containing morphine sulfate 30 mg in 1 mL | Injection | 5 | .. | Hospira Pty Limited | ||||
Naloxone | Injection containing naloxone hydrochloride 800 micrograms in 2 mL disposable injection set | Injection | 1 | .. | Naloxone Min‑I‑Jet | ||||
| Injection containing naloxone hydrochloride 2 mg in 5 mL disposable injection set | Injection | 1 | .. | Naloxone Min‑I‑Jet | ||||
Naproxen | Tablet 250 mg | Oral | 100 | .. | Inza 250 Naprosyn | ||||
| Tablet containing naproxen sodium 550 mg | Oral | 50 | .. | Anaprox 550 Crysanal | ||||
| Tablet 500 mg | Oral | 50 | .. | Inza 500 Naprosyn | ||||
| Tablet 750 mg (sustained release) | Oral | 28 | .. | Naprosyn SR750 Proxen SR 750 | ||||
| Tablet 1 g (sustained release) | Oral | 28 | .. | Naprosyn SR1000 Proxen SR 1000 | ||||
Nitrazepam | Tablet 5 mg | Oral | 25 | .. | Alodorm Mogadon | ||||
Nystatin | Tablet 500,000 units | Oral | 50 | .. | Nilstat | ||||
| Capsule 500,000 units | Oral | 50 | .. | Nilstat | ||||
| Oral suspension 100,000 units per mL, 24 mL | Oral | 1 | .. | Mycostatin Nilstat | ||||
Oxazepam | Tablet 15 mg | Oral | 25 | .. | Alepam 15 Serepax | ||||
| Tablet 30 mg | Oral | 25 | .. | Alepam 30 Murelax Serepax | ||||
Oxycodone | Tablet containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | Endone | ||||
| Capsule containing oxycodone hydrochloride 5 mg | Oral | 20 | .. | OxyNorm | ||||
| Capsule containing oxycodone hydrochloride 10 mg | Oral | 20 | .. | OxyNorm | ||||
| Capsule containing oxycodone hydrochloride 20 mg | Oral | 20 | .. | OxyNorm | ||||
| Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL | Oral | 1 | .. | OxyNorm Liquid 5mg/5mL | ||||
| Tablet containing oxycodone hydrochloride 5 mg (controlled release) | Oral | 20 | .. | OxyContin | ||||
| Tablet containing oxycodone hydrochloride 10 mg (controlled release) | Oral | 20 | .. | OxyContin | ||||
| Tablet containing oxycodone hydrochloride 20 mg (controlled release) | Oral | 20 | .. | OxyContin | ||||
| Tablet containing oxycodone hydrochloride 40 mg (controlled release) | Oral | 20 | .. | OxyContin | ||||
| Tablet containing oxycodone hydrochloride 80 mg (controlled release) | Oral | 20 | .. | OxyContin | ||||
| Suppository 30 mg (as pectinate) | Rectal | 12 | .. | Proladone | ||||
Paracetamol | Tablet 500 mg | Oral | 100 | .. | Chem mart Chemadol | ||||
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| Dymadon P | ||||
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| Febridol | ||||
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| Panamax | ||||
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| Paracetamol Sandoz | ||||
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| Parahexal | ||||
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| Paralgin | ||||
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| Parmol | ||||
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| Terry White Chemists Paracetamol | ||||
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| Tylenol | ||||
| Oral liquid 120 mg per 5 mL, 100 mL | Oral | 1 | .. | Panamax | ||||
| Oral liquid 240 mg per 5 mL, 200 mL | Oral | 1 | .. | Panamax 240 Elixir | ||||
Phenoxymethylpenicillin | Tablet 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin‑VK Filmtab | ||||
| Tablet 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Abbocillin‑VK Filmtab | ||||
| Capsule 250 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK | ||||
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| Cilopen VK | ||||
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| LPV | ||||
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| Penhexal VK | ||||
| Capsule 500 mg phenoxymethylpenicillin (as potassium) | Oral | 50 | .. | Cilicaine VK | ||||
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| Cilopen VK | ||||
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| LPV | ||||
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| Penhexal VK | ||||
| Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | 2 | .. | Abbocillin‑V Cilicaine V | ||||
Piroxicam | Dispersible tablet 10 mg | Oral | 50 | .. | Feldene‑D GenRx Piroxicam Dispersible Mobilis D‑10 | ||||
| Dispersible tablet 20 mg | Oral | 25 | .. | Chem mart Piroxicam Dispersible | ||||
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| Feldene‑D | ||||
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| GenRx Piroxicam Dispersible | ||||
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| Mobilis D‑20 | ||||
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| Terry White Chemists Piroxicam Dispersible | ||||
| Capsule 10 mg | Oral | 50 | .. | Chem mart Piroxicam | ||||
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| Feldene | ||||
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| GenRx Piroxicam | ||||
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| Mobilis 10 | ||||
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| Terry White Chemists Piroxicam | ||||
| Capsule 20 mg | Oral | 25 | .. | Chem mart Piroxicam | ||||
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| Feldene | ||||
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| GenRx Piroxicam | ||||
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| Mobilis 20 | ||||
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| Terry White Chemists Piroxicam | ||||
Procaine Penicillin | Injection 1.5 g in disposable syringe | Injection | 5 | .. | Cilicaine | ||||
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg | Oral | 25 | .. | Stemetil Stemzine | ||||
| Injection containing prochlorperazine mesylate 12.5 mg in 1 mL | Injection | 10 | .. | Stemetil | ||||
| Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 | Rectal | 1 | .. | Stemetil | ||||
Promethazine | Injection containing promethazine hydrochloride 50 mg in 2 mL | Injection | 10 | .. | Hospira Pty Limited | ||||
Sodium Chloride | Injection 9 mg per mL, 10 mL | Injection | 5 | .. | Pfizer Australia Pty Ltd | ||||
| I.V. infusion 154 mmol per L, 1 L | Injection | 5 | .. | Baxter Healthcare Pty Limited | ||||
| I.V. infusion 513 mmol per L, 1 L | Injection | 2 | .. | Baxter Healthcare Pty Limited | ||||
Sodium Chloride with Glucose | I.V. infusion 31 mmol‑222 mmol (anhydrous) per L, 1 L | Injection | 5 | .. | Baxter Healthcare Pty Limited | ||||
| I.V. infusion 19 mmol‑104 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | .. | Baxter Healthcare Pty Limited | ||||
| I.V. infusion 39 mmol‑69 mmol (anhydrous) per 500 mL, 500 mL | Injection | 5 | .. | Baxter Healthcare Pty Limited | ||||
Sulindac | Tablet 100 mg | Oral | 100 | .. | Aclin | ||||
| Tablet 200 mg | Oral | 50 | .. | Aclin 200 | ||||
Temazepam | Tablet 10 mg | Oral | 25 | .. | Normison Temaze Temtabs | ||||
Ticarcillin with Clavulanic Acid | Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent) | Injection | 10 | .. | Timentin | ||||
Tramadol | Capsule containing tramadol hydrochloride 50 mg | Oral | 20 | .. | Chem mart Tramadol | ||||
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| GenRx Tramadol | ||||
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| Terry White Chemists Tramadol | ||||
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| Tramal | ||||
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| Tramedo | ||||
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| Zydol | ||||
| Tablet containing tramadol hydrochloride 50 mg (sustained release) | Oral | 20 | .. | Tramal SR 50 | ||||
| Tablet containing tramadol hydrochloride 100 mg (sustained release) | Oral | 20 | .. | Tramahexal SR Tramal SR 100 Tramedo SR 100 Zydol SR 100 | ||||
| Tablet containing tramadol hydrochloride 150 mg (sustained release) | Oral | 20 | .. | Tramahexal SR Tramal SR 150 Tramedo SR 150 Zydol SR 150 | ||||
| Tablet containing tramadol hydrochloride 200 mg (sustained release) | Oral | 20 | .. | Tramahexal SR Tramal SR 200 Tramedo SR 200 Zydol SR 200 | ||||
| Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL | Oral | 1 | .. | Tramal | ||||
| Injection containing tramadol hydrochloride 100 mg in 2 mL | Injection | 5 | .. | Tramahexal Tramal 100 | ||||
Triamcinolone | Injection containing triamcinolone acetonide 10 mg in 1 mL | Injection | 5 | .. | Kenacort‑A10 | ||||
Trimethoprim with Sulfamethoxazole | Tablet 80 mg‑400 mg | Oral | 10 | .. | Resprim | ||||
| Tablet 160 mg‑800 mg | Oral | 10 | .. | Bactrim DS | ||||
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| Chem mart Trimethoprim with Sulfamethoxazole DS | ||||
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| GenRx Trimethoprim with Sulfamethoxazole DS | ||||
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| Resprim Forte | ||||
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| Septrin Forte | ||||
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| Terry White Chemists Trimethoprim with Sulfamethoxazole DS | ||||
| Paediatric oral suspension 40 mg‑200 mg per 5 mL, 100 mL | Oral | 1 | .. | Bactrim Septrin | ||||
Vancomycin | Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) | Injection | 2 | .. | Hospira Pty Limited Vancocin CP Vancomycin Sandoz | ||||
| Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) | Injection | 1 | .. | Hospira Pty Limited Vancomycin Sandoz | ||||
Ibuprofen | Tablet 400 mg | Chronic arthropathies (including osteoarthritis) with an inflammatory component Bone pain due to malignant disease | Oral | 90 | .. | Brufen |
Metronidazole | Tablet 400 mg | Treatment of anaerobic infections | Oral | 21 | .. | Flagyl Metrogyl 400 Metronide 400 |
Paracetamol | Tablet 500 mg | Chronic arthropathies | Oral | 300 | .. | Chem mart Chemadol |
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| Dymadon P |
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| Febridol |
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| Panamax |
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| Paracetamol Sandoz |
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| Parahexal |
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| Paralgin |
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| Parmol |
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| Terry White Chemists Paracetamol |
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| Tylenol |
Creams | 100 g | 1 |
Dusting Powders | 100 g | 1 |
Ear Drops | 15 mL | 2 |
Eye Drops containing Cocaine Hydrochloride BP | 15 mL | .. |
Eye Drops, Other | 15 mL | 5 |
Eye Lotions | 200 mL | 2 |
Inhalations | 50 mL | 1 |
Linctuses containing Codeine Phosphate BP | 100 mL | .. |
Linctuses, Other | 100 mL | 2 |
Lotions | 200 mL | 2 |
Mixtures containing Codeine Phosphate BP | 200 mL | .. |
Mixtures, Other | 200 mL | 4 |
Mixtures for Children containing Codeine Phosphate BP | 100 mL | .. |
Mixtures for Children, Other | 100 mL | 4 |
Mouth Washes | 200 mL | 1 |
Nasal Instillations | 15 mL | 2 |
Ointments, Waxes | 100 g | 1 |
Paints | 25 mL | 1 |
Pastes containing Cocaine Hydrochloride BP | 25 g | .. |
Pastes, Other | 100 g | 1 |
Powders for Internal Use | 100 g | 2 |
Solutions | 200 mL | 2 |
Notes to the Determination — pharmaceutical benefits (PB 89 of 2007)
Note 1
The Determination — pharmaceutical benefits (PB 89 of 2007) (in force under sections 85, 85A and 88 of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.
Table of Instruments
Title | Date of FRLI Registration | Date of | Application, saving or |
PB 89 of 2007 | 15 Nov 2007 (see F2007L04361) | 1 Dec 2007 |
|
PB 2 of 2008 | 23 Nov 2007 (see F2007L04464) | 1 Jan 2008 | — |
PB 7 of 2008 | 19 Dec 2007 (see F2007L04904) | 1 Jan 2008 | — |
PB 15 of 2008 | 9 Jan 2008 (see F2008L00034) | 1 Feb 2008 | — |
PB 24 of 2008 | 7 Feb 2008 (see F2008L00282) | 1 Mar 2008 | — |
PB 31 of 2008 | 11 Mar 2008 (see F2008L00692) | 1 Apr 2008 | — |
PB 42 of 2008 | 10 Apr 2008 (see F2008L01028) | 1 May 2008 | — |
PB 51 of 2008 | 12 May 2008 (see F2008L01383) | 1 June 2008 | — |
PB 60 of 2008 | 11 June 2008 (see F2008L02049) | 1 July 2008 | — |
PB 70 of 2008 | 2 July 2008 (see F2008L02299) | (a) | — |
(a) Section 1 of PB 70 of 2008 provides as follows:
1 Commencement
This instrument commences at 11.59 pm on 31 July 2008.
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
Provision affected | How affected |
Schedule 1 |
|
Part 1..................... | am. PB 2, 7, 15, 24, 31, 42, 51, 60 and 70 of 2008 |
Part 2..................... | am. PB 2, 7, 15, 24, 31, 42, 51 and 60 of 2008 |
Schedule 2 |
|
Part 1.................... | am. PB 31 and 70 of 2008 |
Part 2..................... | am. PB 31 and 70 of 2008 |
Schedule 3 |
|
Part 1..................... | am. PB 7, 15, 24, 31, 42, 51 and 60 of 2008 |
Part 2..................... | am. PB 7 of 2008 |
Note 2
Part 1 of Schedule 1 — Schedule 1 [item 7] of PB 60 of 2008 provides as follows:
[7] Part 1 of Schedule 1, item dealing with Folinic acid
omit from the column headed “Brand” (wherever occurring):
Leucovorin (Hospira Australia Pty Ltd)
and substitute:
Leucovorin (Hospira Pty Limited)
The proposed amendment was misdescribed and is not incorporated in this compilation.