Schedule 1 Amendments
[1] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 4]
omit from the column headed “Circumstances”:
C3568 C3569
insert in numerical order:
C3706 C3707
[2] Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 100 mg
omit:
| | | | Rithmik 100 | QA | MP NP | C1350 | | 30 | 5 | |
[3] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Pharmacor Cephalexin 250 | CR | PDP | | | 20 | 0 | |
[4] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Pharmacor Cephalexin 250 | CR | MP NP MW | | | 20 | 1 | |
[5] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Pharmacor Cephalexin 500 | CR | PDP | | | 20 | 0 | |
[6] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Pharmacor Cephalexin 500 | CR | MP NP MW | | | 20 | 1 | |
[7] Schedule 1, after entry for Desmopressin in the form Wafer 120 micrograms (as acetate)
insert in the columns in the order indicated:
| | Wafer 240 micrograms (as acetate) | Sublingual | Minirin Melt | FP | MP NP | C2641 C2642 | | 30 | 5 | |
[8] Schedule 1, entry for Desvenlafaxine
omit from the column headed “Responsible Person” (twice occurring): WX substitute: PF
[9] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection) [Max Quantity 1; Number of Repeats 0]
omit from the column headed “Circumstances”:
C3292
[10] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection) [Max Quantity 2; Number of Repeats 0]
(a) omit from the column headed “Circumstances”:
C3292
(b) omit from the column headed “Purposes”:
P3292
[11] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL (DBL Docetaxel Concentrated Injection)
omit from the column headed “Circumstances”:
C3292
[12] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL
omit from the column headed “Circumstances”:
C3292
[13] Schedule 1, omit entry for Dolasetron
[14] Schedule 1, after entry for Dutasteride
insert:
| Dutasteride with tamsulosin | Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms | Oral | Duodart 500ug/400ug | GK | MP NP | C3687 | | 30 | 5 | |
[15] Schedule 1, entry for Epoetin Alfa
omit:
| | Injection 30,000 units in 0.75 mL pre-filled syringe | Injection | Eprex 30,000 | JC | MP
See Note 1 | C1957 C3334 | | 12 | 5 | D |
[16] Schedule 1, entry for Etanercept
omit from the column headed “Responsible Person” (all instances): WX substitute: PF
[17] Schedule 1, entry for Exemestane
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Exaccord | RA | MP NP | C1541 C2457 | | 30 | 5 | |
[18] Schedule 1, entry for Fentanyl
omit:
| | Lozenges 200 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 3 | 0 | |
| | | | | | MP NP | C3663 C3664 | P3664 | 20 | 0 | |
| | Lozenges 400 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 3 | 0 | |
| | | | | | MP NP | C3663 C3664 | P3664 | 20 | 0 | |
| | Lozenges 600 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 3 | 0 | |
| | | | | | MP NP | C3663 C3664 | P3664 | 20 | 0 | |
| | Lozenges 800 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 3 | 0 | |
| | | | | | MP NP | C3663 C3664 | P3664 | 20 | 0 | |
| | Lozenges 1200 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 3 | 0 | |
| | | | | | MP NP | C3663 C3664 | P3664 | 20 | 0 | |
| | Lozenges 1600 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 C3664 | P3663 | 3 | 0 | |
| | | | | | MP NP | C3663 C3664 | P3664 | 20 | 0 | |
substitute:
| | Lozenges 200 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | | 3 | 0 | |
| | Lozenges 400 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | | 3 | 0 | |
| | Lozenges 600 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | | 3 | 0 | |
| | Lozenges 800 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | | 3 | 0 | |
| | Lozenges 1200 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | | 3 | 0 | |
| | Lozenges 1600 micrograms (as citrate), 3 | Buccal | Actiq | OA | MP NP | C3663 | | 3 | 0 | |
| | Lozenges 200 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | | 2 | 0 | |
| | Lozenges 400 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | | 2 | 0 | |
| | Lozenges 600 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | | 2 | 0 | |
| | Lozenges 800 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | | 2 | 0 | |
| | Lozenges 1200 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | | 2 | 0 | |
| | Lozenges 1600 micrograms (as citrate), 30 | Buccal | Actiq | OA | MP NP | C3664 | | 2 | 0 | |
[19] Schedule 1, after entry for Fentanyl in the form Transdermal patch 2.1 mg
insert in the columns in the order indicated:
| | Transdermal patch 2.55 mg | Transdermal | Denpax | AF | MP NP | C1062 | | 5 | 0 | |
[20] Schedule 1, after entry for Fentanyl in the form Transdermal patch 4.2 mg
insert in the columns in the order indicated:
| | Transdermal patch 5.10 mg | Transdermal | Denpax | AF | MP NP | C1062 | | 5 | 0 | |
| | Transdermal patch 7.65 mg | Transdermal | Denpax | AF | MP NP | C1062 | | 5 | 0 | |
[21] Schedule 1, after entry for Fentanyl in the form Transdermal patch 8.4 mg
insert in the columns in the order indicated:
| | Transdermal patch 10.20 mg | Transdermal | Denpax | AF | MP NP | C1062 | | 5 | 0 | |
[22] Schedule 1, entry for Filgrastim
insert as first entry in the columns in the order indicated:
| | Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim) | Injection | Nivestim | HH | MP
See Note 1 | C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 | | 20 | 11 | D |
[23] Schedule 1, entry for Fluconazole in the form Capsule 100 mg
omit:
| | | | Fluconazole Winthrop | WA | MP NP | C3613 C3614 C3615 C3616 C3617 C3618 | | 28 | 5 | |
[24] Schedule 1, entry for Glucose Indicator—Urine
omit:
| | Test strips, 50 (Clinistix) | For external use | Clinistix | BN | MP NP | | | 2 | 2 | |
| | | | | | MP | | P3035 | 2 | 4 | |
[25] Schedule 1, entry for Golimumab
omit from the column headed “Responsible Person” (twice occurring): SH substitute: JC
[26] Schedule 1, entry for Hypromellose in the form Oral gel 20 mg per g, 100 g
omit from the column headed “Responsible Person”: HA substitute: VT
[27] Schedule 1, entry for Infliximab
omit from the column headed “Responsible Person”: SH substitute: JC
[28] Schedule 1, entry for Lansoprazole in each of the forms: Tablet 30 mg (orally disintegrating); and Tablet 15 mg (orally disintegrating)
omit from the column headed “Responsible Person”: WX substitute: PF
[29] Schedule 1, entry for Leflunomide in the form Tablet 10 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | APO-Leflunomide | TX | MP | C2644 | 30 | 5 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Lunava 10 | ZP | MP | C2644 | 30 | 5 | | |
[30] Schedule 1, entry for Leflunomide in the form Tablet 20 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | APO-Leflunomide | TX | MP | C2644 | 30 | 5 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | Lunava 20 | ZP | MP | C2644 | 30 | 5 | | |
[31] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets
(a) omit from the column headed “Responsible Person”: WX substitute: FZ
(b) omit from the column headed “Responsible Person”: WY substitute: PF
[32] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 6 tablets 50 micrograms-30 micrograms,
5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets
(a) omit from the column headed “Responsible Person”: WX substitute: FZ
(b) omit from the column headed “Responsible Person”: WY substitute: PF
[33] Schedule 1, entry for Maraviroc
omit from the column headed “Responsible Person” (twice occurring): PF substitute: VI
[34] Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg
omit:
| | | | Meloxicam Winthrop | WA | MP NP | C1547 C1848 | | 30 | 3 | |
[35] Schedule 1, entry for Methylnaltrexone
omit from the column headed “Responsible Person: WX substitute: PF
[36] Schedule 1, after entry for Methylprednisolone in the form Injection containing methylprednisolone acetate 40 mg in 1 mL
(Depo-Nisolone)
insert in the columns in the order indicated:
| | Powder for injection 40 mg (as sodium succinate) | Injection | Methylpred | AS | MP NP | | | 5 | 0 | |
[37] Schedule 1, after entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate) with diluent
insert in the columns in the order indicated:
| | Powder for injection 1 g (as sodium succinate) | Injection | Methylpred | AS | MP NP | | | 1 | 0 | |
[38] Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and
Tablet 45 mg (as hydrochloride) (Pizaccord)
omit from the column headed “Responsible Person”: MI substitute: RA
[39] Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses
(CFC-free formulation)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | | APO-Salbutamol Inhaler | TX | MP NP | | | 2 | 5 | |
[40] Schedule 1, entry for Sirolimus in the form Tablet 0.5 mg
omit from the column headed “Brand”: Rapamune (Pfizer Australia Pty Ltd) substitute: Rapamune
[41] Schedule 1, entry for Sirolimus
omit from the column headed “Responsible Person” (all instances): WX substitute: PF
[42] Schedule 1, entry for Somatropin in the form Injection 4 mg (12 i.u.) vial with 3.5 mL diluent (with preservative)
omit from the column headed “Form”: 3.5 mL
[43] Schedule 1, after entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)
insert in the columns in the order indicated:
| | Injection 10 mg (30 i.u.) vial with diluent (with preservative) | Injection | Zomacton | FP | MP See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | D |
[44] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 0]
(a) omit from the column headed “Responsible Person”: AL substitute: AF
(b) omit:
| | | | Zabel | AF | MP NP | C2191 C2865 C3244 | P2865 P3244 | 42 | 0 | |
[45] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 1]
(a) omit from the column headed “Responsible Person”: AL substitute: AF
(b) omit:
| | | | Zabel | AF | MP NP | C2191 C2865 C3244 | P2191 | 42 | 1 | |
[46] Schedule 1, entry for Venlafaxine
omit from the column headed “Responsible Person” (all instances): WX substitute: PF
[47] Schedule 3
omit:
| SH | Schering-Plough Pty Limited | 57 000 235 245 |
[48] Schedule 3
omit:
| WX | Wyeth Australia Pty Limited | 16 000 296 211 |
| WY | Wyeth Australia Pty Limited | 16 000 296 211 |
[49] Schedule 4, Part 1, entry for Capecitabine for the circumstances code C3509
omit from the column headed “Circumstances and Purposes”: oesopho-gastric substitute: oesophago-gastric
[50] Schedule 4, Part 1, omit entry for Dolasetron
[51] Schedule 4, Part 1, after entry for Dutasteride
insert:
| Dutasteride with tamsulosin | C3687 | | Treatment of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment has been initiated by a urologist | Compliance with Authority Required procedures - Streamlined Authority Code 3687 |
[52] Schedule 4, Part 1, entry for Ezetimibe with Simvastatin
omit:
| | C3194 | | Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) must be reduced to a dose of 20 mg or less per day, because the patient developed a clinically important product-related adverse event during treatment with a statin.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin | Compliance with Authority Required procedures - Streamlined Authority Code 3194
|
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See http://www.frli.gov.au.