Schedule 1 Amendments
[1] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity 10; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | APO-Amoxycillin and Clavulanic Acid | TX | PDP | C1836 C1837 | | 10 | 0 | 10 | | |
[2] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity 10; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | APO-Amoxycillin and Clavulanic Acid | TX | MP NP | C1836 C1837 | | 10 | 1 | 10 | | |
[3] Schedule 1, entry for Cefalotin
(a) omit:
| | | Keflin Neutral | AS | PDP | | | 10 | 0 | 10 | | |
(b) omit:
| | | Keflin Neutral | AS | MP NP | | | 10 | 1 | 10 | | |
[4] Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacor Donepezil 5 | CR | MP NP | C4219 C4220 C4224 | | 28 | 5 | 28 | | |
[5] Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacor Donepezil 10 | CR | MP NP | C4219 C4220 C4224 | | 28 | 5 | 28 | | |
[6] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 7; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Doxycycline Sandoz | HX | PDP | | | 7 | 0 | 7 | | |
[7] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 7; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Doxycycline Sandoz | HX | MP NP | | | 7 | 1 | 7 | | |
[8] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 21; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Doxycycline Sandoz | HX | MP NP | | P1459 | 21 | 0 | 7 | | |
[9] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 28; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Doxycycline Sandoz | HX | MP NP | | P1279 | 28 | 0 | 7 | | |
[10] Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Coperin | AF | MP NP | C1211 | | 28 | 0 | 28 | | |
[11] Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Coperin | AF | MP NP | C1211 | | 28 | 5 | 28 | | |
[12] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit:
| | | Epirubicin SZ | HX | MP | | | See Note 3 | See Note 3 | 1 | | D(100) |
[13] Schedule 1, entry for Imiquimod
insert as first entry in the columns in the order indicated:
| Cream 50 mg per g, 2 g, 2 | Application | Aldara Pump | IA | MP | C4229 | | 1 | 1 | 1 | | |
[14] Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12
omit from the column headed “Circumstances” (twice occurring): C2816 substitute: C4229
[15] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
omit:
| | | Irinotecan SZ | HX | MP | C3184 | | See Note 3 | See Note 3 | 1 | | D(100) |
[16] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol
insert as first entry in the columns in the order indicated:
| Pack containing 21 tablets 100 micrograms-20 micrograms and 7 inert tablets | Oral | Femme-Tab ED 20/100 | AE | MP NP | | | 4 | 2 | 4 | | |
[17] Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
omit:
[18] Schedule 1, entry for Nicotine in the form Transdermal patch 24.9 mg
omit from the column headed “Circumstances”:
C3042 C3447 C3448
substitute:
C4231 C4232 C4233
[19] Schedule 1, entry for Nicotine in the form Transdermal patch 114 mg
omit from the column headed “Circumstances”:
C3042 C3447 C3448
substitute:
C4231 C4232 C4233
[20] Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg and Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacy Choice Olanzapine | RI | MP NP | C1589 C2044 | | 28 | 5 | 28 | | |
[21] Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Olanzapine RBX ODT | RA | MP NP | C1589 C2044 | | 28 | 5 | 28 | | |
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacy Choice Olanzapine ODT | RI | MP NP | C1589 C2044 | | 28 | 5 | 28 | | |
[22] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine
(as besylate)
omit from the column headed “Brand”: Coveram substitute: Coveram 5/5
[23] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine
(as besylate)
omit from the column headed “Brand”: Coveram substitute: Coveram 5/10
[24] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine
(as besylate)
omit from the column headed “Brand”: Coveram substitute: Coveram 10/5
[25] Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine
(as besylate)
omit from the column headed “Brand”: Coveram substitute: Coveram 10/10
[26] Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacy Choice Quetiapine | RI | MP NP | C1589 C2044 C2765 | | 60 | 5 | 60 | | |
[27] Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacy Choice Quetiapine | RI | MP NP | C1589 C2044 C2765 | | 90 | 5 | 90 | | |
[28] Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Pharmacy Choice Quetiapine | RI | MP NP | C1589 C2044 C2765 | | 60 | 5 | 60 | | |
[29] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity 30; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Rabeprazole Actavis 20 | TA | MP NP | C1177 C1337 C1533 | P1177 | 30 | 2 | 30 | | |
[30] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Rabeprazole Actavis 20 | TA | MP NP | C1177 C1337 C1533 | P1337 P1533 | 30 | 5 | 30 | | |
[31] Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | Acris Once-a-Month | AF | MP NP | C4117 C4122 C4123 | | 1 | 5 | 1 | | |
[32] Schedule 1, entry for Sorafenib
omit from the column headed “Circumstances”:
C3071 C3072
substitute:
C4230 C4234
[33] Schedule 1, entry for Tetrabenazine
(a) omit from the column headed “Brand”: Orphan Australia Pty Ltd substitute: iNova Pharmaceuticals (Australia) Pty Ltd
(b) omit from the column headed “Responsible Person”: OA substitute: IA
[34] Schedule 4, Part 1, entry for Imiquimod
substitute:
Imiquimod | C4229 | | | Superficial basal cell carcinoma The condition must be previously untreated;
The condition must be confirmed by biopsy;
Patient must have normal immune function;
The condition must not be suitable for treatment with cryotherapy; OR
The condition must not be suitable for treatment with curettage with diathermy; OR
The condition must not be suitable for treatment with surgical excision,
Patient must require topical drug therapy The date of the pathology report and name of the Approved Pathology Authority must be provided at the time of application | Compliance with Authority Required procedures |
[35] Schedule 4, Part 1, entry for Nicotine
insert in numerical order after existing text:
| C4231 | | | Nicotine dependence The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have indicated they are ready to cease smoking;
Patient must have entered a comprehensive support and counselling program;
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per year Details of the support and counselling program must be specified in the initial authority application | Compliance with Authority Required procedures
|
| C4232 | | | Nicotine dependence Patient must be an Aboriginal or a Torres Strait Islander person;
The treatment must be the sole PBS-subsidised therapy for this condition | Compliance with Authority Required procedures |
| C4233 | | | Nicotine dependence The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have indicated they are ready to cease smoking;
Patient must be entering a comprehensive support and counselling program during the consultation at which this authority is requested;
Patient must not receive more than 12 weeks of PBS-subsidised nicotine replacement therapy per year Details of the support and counselling program must be specified in the initial authority application | Compliance with Authority Required procedures
|
[36] Schedule 4, Part 1, entry for Sorafenib
substitute:
Sorafenib | C4230 | | | Advanced Barcelona Clinic Liver Cancer Stage C hepatocellular carcinoma Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have a WHO performance status of 2 or less;
Patient must have Child Pugh class A | Compliance with Authority Required procedures - Streamlined Authority Code 4230
|
| C4234 | | | Advanced Barcelona Clinic Liver Cancer Stage C hepatocellular carcinoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition;
Patient must have previously been treated with PBS-subsidised sorafenib;,
Patient must not have progressive disease | Compliance with Authority Required procedures - Streamlined Authority Code 4234
|
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.comlaw.gov.au
