Schedule 1 Amendments
[1] Schedule 1, entry for Apixaban
substitute:
Apixaban | Tablet 2.5 mg | Oral | Eliquis | BQ | MP NP | C3957 C3991 C4043 C4044 C4046 C4269 | P3957 P4043 | 20 | 0 | 20 | | |
| | | | | MP NP | C3957 C3991 C4043 C4044 C4046 C4269 | P3991 P4044 | 30 | 0 | 30 | | |
| | | | | MP NP | C3957 C3991 C4043 C4044 C4046 C4269 | P4046 | 60 | 0 | 60 | | |
| | | | | MP NP | C3957 C3991 C4043 C4044 C4046 C4269 | P4269 | 60 | 5 | 60 | | |
| Tablet 5 mg | Oral | Eliquis | BQ | MP NP | C4269 | | 60 | 5 | 60 | | |
[2] Schedule 1, entry for Buprenorphine with naloxone
omit:
| Tablet (sublingual) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride) | Sublingual | Suboxone | RC | MP NP
See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 28 | | D(100) |
| Tablet (sublingual) 8 mg (as hydrochloride)-2 mg (as hydrochloride) | Sublingual | Suboxone | RC | MP NP
See Note 1 | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 28 | | D(100) |
[3] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Candesartan/ HCT Sandoz | SZ | MP NP | C3307 | | 30 | 5 | 30 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacor Candesartan HCT 16/12.5 | CR | MP NP | C3307 | | 30 | 5 | 30 | | |
[4] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Candesartan/ HCT Sandoz | SZ | MP NP | C3307 | | 30 | 5 | 30 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacor Candesartan HCT 32/12.5 | CR | MP NP | C3307 | | 30 | 5 | 30 | | |
[5] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Candesartan/ HCT Sandoz | SZ | MP NP | C3307 | | 30 | 5 | 30 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacor Candesartan HCT 32/25 | CR | MP NP | C3307 | | 30 | 5 | 30 | | |
[6] Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g
(as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Cefepime-AFT | AE | MP NP | C1427 | | 10 | 0 | 1 | | |
[7] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg
(a) omit:
| | | Cyprohexal | SZ | MP | C1014 C1230 C1404 | P1230 | 20 | 5 | 20 | | |
(b) omit:
| | | Cyprohexal | SZ | MP | C1014 C1230 C1404 | P1014 P1404 | 100 | 5 | 50 | | |
[8] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit:
| | | Cyprohexal | SZ | MP | C1014 C1404 | | 50 | 5 | 50 | | |
[9] Schedule 1, entry for Dabigatran etexilate
omit:
| Capsule 110 mg (as mesilate) | Oral | Pradaxa | BY | MP NP | C3957 C4047 C4048 | P3957 | 20 | 0 | 10 | | |
| | | | | MP NP | C3957 C4047 C4048 | P4047 | 20 | 1 | 10 | | |
| | | | | MP NP | C3957 C4047 C4048 | P4048 | 60 | 0 | 60 | | |
substitute:
| Capsule 110 mg (as mesilate) | Oral | Pradaxa | BY | MP NP | C3957 C4047 C4048 C4269 | P3957 | 20 | 0 | 10 | | |
| | | | | MP NP | C3957 C4047 C4048 C4269 | P4047 | 20 | 1 | 10 | | |
| | | | | MP NP | C3957 C4047 C4048 C4269 | P4048 | 60 | 0 | 60 | | |
| | | | | MP NP | C3957 C4047 C4048 C4269 | C4269 | 60 | 5 | 60 | | |
| Capsule 150 mg (as mesilate) | Oral | Pradaxa | BY | MP NP | C4269 | | 60 | 5 | 60 | | |
[10] Schedule 1, entry for Duloxetine in each of the forms Capsule 30 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)
[Manner of Administration Oral; Brand Duloxetine DR GH]
omit from “Duloxetine DR GH” in the column headed “Brand”: DR
[11] Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity 21; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Auro-Famciclovir 250 | DO | MP NP | C3622 C3623 | P3622 | 21 | 0 | 21 | | |
[12] Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity 56; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Auro-Famciclovir 250 | DO | MP NP | C3622 C3623 | P3623 | 56 | 5 | 56 | | |
[13] Schedule 1, after entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)
insert in the columns in the order indicated:
| Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Zarzio) | Injection | Zarzio | SZ | 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 C3833 C3834 | | 20 | 11 | 5 | | D(100) |
[14] Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
insert in the columns in the order indicated:
| Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Zarzio) | Injection | Zarzio | SZ | 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 C3833 C3834 | | 20 | 11 | 5 | | D(100) |
[15] Schedule 1, after entry for Flutamide in the form Tablet 250 mg
insert:
| Tablet 250 mg, 30 | Oral | Flutamide MYLAN | AF | MP NP | C3674 | | 3 | 5 | 1 | | |
| | | | | | | | | | | | |
[16] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit:
| | | Gemzar | LY | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[17] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit:
| | | Gemzar | LY | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[18] Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Gemcitabine Actavis 2000 | WQ | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[19] Schedule 1, entry for Granisetron in the form Concentrated injection 3 mg (as hydrochloride) in 3 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Granisetron-AFT | AE | MP NP
See Note 1 | C4077 C4092
See Note 2 | | 1
See Note 2 | 0
See Note 2 | 1 | | |
[20] Schedule 1, entry for Hydroxychloroquine
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Hydroxychloro
quine Actavis | GM | MP NP | | | 100 | 1 | 100 | | |
[21] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:
| | | Formet 500 | QA | MP NP | | | 100 | 5 | 100 | | |
[22] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
[23] Schedule 1, entry for Misoprostol
omit:
| | | Cytotec | PF | MP | C2630 C2631 C2632 | | 120 | 2 | 120 | | |
[24] Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacor Montelukast 4 | CR | MP NP | C2617 | | 28 | 5 | 28 | | |
[25] Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacor Montelukast 5 | CR | MP NP | C2618 C3217 | | 28 | 5 | 28 | | |
[26] Schedule 1, entry for Norfloxacin
omit:
| | | Noroxin | MK | MP NP | C1002 C1070 | | 14 | 1 | 14 | | |
[27] Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
omit:
| | | Zofran | AS | MP NP
See Note 1 | C3050 C3611
See Note 2 | See Note 2 | 1
See Note 2 | 0
See
Note 2 | 1 | | |
[28] Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; and Solution concentrate for I.V. infusion 100 mg in 16.7 mL
omit:
| | | Paclitaxel Pfizer | PF | MP | C3186 C3890 C3902 C3917 C3955 C3956 | | See Note 3 | See Note 3 | 1 | | D(100) |
[29] Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)
omit:
[30] Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)
omit:
[31] Schedule 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)
omit:
[32] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a) omit:
| | | Rabeprazole Actavis 20 | TA | MP NP | C1177 C1337 C1533 | P1177 | 30 | 2 | 30 | | |
(b) omit:
| | | Rabeprazole Actavis 20 | TA | MP NP | C1177 C1337 C1533 | P1337 P1533 | 30 | 5 | 30 | | |
[33] Schedule 1, entry for Raltegravir
substitute:
Raltegravir | Tablet 25 mg (as potassium) | Oral | Isentress | MK | MP
See Note 1 | C4273 C4274 C4275 C4276 | | 360 | 5 | 60 | | D(100) |
| Tablet 100 mg (as potassium) | Oral | Isentress | MK | MP
See Note 1 | C4273 C4274 C4275 C4276 | | 360 | 5 | 60 | | D(100) |
| Tablet 400 mg (as potassium) | Oral | Isentress | MK | MP
See Note 1 | C3586 C3587 C3588 C3589 | | 120 | 5 | 60 | | D(100) |
[34] Schedule 1, entry for Risedronic Acid and Calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)
omit:
| | | Actonel Combi | SW | MP NP | C4122 C4123 C4133 | | 1 | 5 | 1 | | |
[35] Schedule 1, entry for Salbutamol
omit:
| Nebuliser solution 5 mg (as sulfate) per mL, 30 mL | Inhalation | Pfizer Australia Pty Ltd | PF | MP NP | C1754 C1755 | | 2 | 2 | 1 | | |
[36] Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
omit:
| | | Sumagran 50 | QA | MP NP | C3233 | | 4 | 5 | 2 | | |
[37] Schedule 1, after entry for Tadalafil
insert:
Tafluprost | Eye drops 15 micrograms per mL, single dose units 0.3 mL, 30 | Application to the eye | Saflutan | MK | MP AO | | | 1 | 5 | 1 | | |
[38] Schedule 4, Part 1, entry for Apixaban
insert in numerical order following existing text:
| C4269 | P4269 | | Prevention of stroke or systemic embolism Patient must have non-valvular atrial fibrillation Patient must have one or more risk factors for developing stroke or systemic embolism Risk factors for developing stroke or systemic ischaemic embolism are: (i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism; (ii) age 75 years or older; (iii) hypertension; (iv) diabetes mellitus; (v) heart failure and/or left ventricular ejection fraction 35% or less | Compliance with Authority Required procedures - Streamlined Authority Code 4269 |
[39] Schedule 4, Part 1, entry for Dabigatran etexilate
insert in numerical order following existing text:
| C4269 | P4269 | | Prevention of stroke or systemic embolism Patient must have non-valvular atrial fibrillation Patient must have one or more risk factors for developing stroke or systemic embolism Risk factors for developing stroke or systemic ischaemic embolism are: (i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism; (ii) age 75 years or older; (iii) hypertension; (iv) diabetes mellitus; (v) heart failure and/or left ventricular ejection fraction 35% or less | Compliance with Authority Required procedures - Streamlined Authority Code 4269 |
[40] Schedule 4, Part 1, entry for Misoprostol
omit:
| C2630 | | | Reduction in the incidence of gastrointestinal complications in patients who have a history of peptic ulcer disease and where non-steroidal anti-inflammatory drug therapy is essential | Compliance with Authority Required procedures - Streamlined Authority Code 2630 |
| C2631 | | | Duodenal ulcer (including pyloric and stomal ulcers), proven by current or prior x-ray, endoscopy or surgery, where the date on which, and the method by which, the ulcer was proven are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2631 |
| C2632 | | | Gastric ulcer, proven by x-ray, endoscopy or surgery within the previous 2 years, where the date on which, and the method by which, the ulcer was proven are documented in the patient's medical records when treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 2632 |
[41] Schedule 4, Part 1, entry for Raltegravir
insert in numerical order following existing text:
| C4273 | | | Where the patient is receiving treatment at/from a private hospital HIV infection Continuing treatment The treatment must be in combination with other antiretroviral agents, Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy, Patient must have previously received PBS-subsidised therapy for HIV infection, Patient must be aged 2 years or older | Compliance with Written and Telephone Authority Required procedures |
| C4274 | | | Where the patient is receiving treatment at/from a public hospital HIV infection Continuing treatment The treatment must be in combination with other antiretroviral agents, Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy, Patient must have previously received PBS-subsidised therapy for HIV infection, Patient must be aged 2 years or older | Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4274 |
| C4275 | | | Where the patient is receiving treatment at/from a public hospital HIV infection Initial treatment The treatment must be in combination with other antiretroviral agents, Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy, Patient must have a CD4 count of less than 500 per cubic millimetre; OR Patient must have symptomatic HIV disease, Patient must be aged 2 years or older | Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4275 |
| C4276 | | | Where the patient is receiving treatment at/from a private hospital HIV infection Initial treatment The treatment must be in combination with other antiretroviral agents, Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti-retroviral therapy, Patient must have a CD4 count of less than 500 per cubic millimetre; OR Patient must have symptomatic HIV disease, Patient must be aged 2 years or older | Compliance with Written and Telephone Authority Required procedures |
