Schedule 1 - Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
[1] Schedule 1, Part 1, entry for Aciclovir in the form Tablet 200 mg
(a) omit:
| | | a | Aciclovir AN | ED | MP NP | C5942 | | 90 | 5 | 90 | | |
(b) omit:
[2] Schedule 1, Part 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg
omit:
| | | a | Novatin | TX | MP | C5727 C5789 | | 100 | 2 | 100 | | |
[3] Schedule 1, Part 1, entry for Alendronic acid
omit:
| | | a | Densate 70 | DO | MP NP | C6310 C6323 C6327 | | 4 | 5 | 4 | | |
[4] Schedule 1, Part 1, entry for Amisulpride in the form Tablet 100 mg
omit:
| | | a | Amisulpride AN | EA | MP NP | C4246 | | 30 | 5 | 30 | | |
[5] Schedule 1, Part 1, entry for Amisulpride in each of the forms: Tablet 200 mg; and Tablet 400 mg
omit:
| | | a | Amisulpride AN | EA | MP NP | C4246 | | 60 | 5 | 60 | | |
[6] Schedule 1, Part 1, entry for Amlodipine in the form Tablet 5 mg (as besilate)
(a) omit:
| | | a | Amlodipine AN | EA | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Auro-Amlodipine 5 | DO | MP NP | | | 30 | 5 | 30 | | |
[7] Schedule 1, Part 1, entry for Amlodipine in the form Tablet 10 mg (as besilate)
(a) omit:
| | | a | Amlodipine AN | EA | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Auro-Amlodipine 10 | DO | MP NP | | | 30 | 5 | 30 | | |
[8] Schedule 1, Part 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate)
(a) omit:
| | | a | Amoxycillin AN | EA | MP NP MW PDP | | | 20 | 0 | 20 | | |
(b) omit:
| | | a | Amoxycillin AN | EA | MP NP | | P10404 | 40
CN10404 | 0
CN10404 | 20 | | |
[9] Schedule 1, Part 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate)
(a) omit:
| | | a | Amoxycillin AN | EA | MP NP MW PDP | | | 20 | 0 | 20 | | |
(b) omit:
| | | a | Amoxycillin AN | EA | MP NP | | P10402 | 40
CN10402 | 0
CN10402 | 20 | | |
[10] Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
(a) omit:
| | | a | AMOXICLAV AMNEAL 500/125 | ED | MP NP | C5832 C5893 C10405 | P5832 P5893 | 10 | 0 | 10 | | |
| | | | | | MW | C5832 C5893 | | 10 | 0 | 10 | | |
| | | | | | PDP | C5833 C5894 | | 10 | 0 | 10 | | |
(b) omit:
| | | a | AMOXICLAV AMNEAL 500/125 | ED | MP NP | C5832 C5893 C10405 | P10405 | 20 | 0 | 10 | | |
[11] Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
(a) omit:
| | | a | AMOXICLAV AMNEAL 875/125 | ED | MP NP | C5832 C5893 C10413 | P5832 P5893 | 10 | 0 | 10 | | |
| | | | | | PDP | C5833 C5894 | | 10 | 0 | 10 | | |
(b) omit:
| | | a | AMOXICLAV AMNEAL 875/125 | ED | MP NP | C5832 C5893 C10413 | P10413 | 20 | 0 | 10 | | |
[12] Schedule 1, Part 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; Tablet 20 mg; and Tablet 30 mg
omit:
| | | a | Aripiprazole AN | EA | MP NP | C4246 | | 30 | 5 | 30 | | |
[13] Schedule 1, Part 1, entry for Atenolol in the form Tablet 50 mg
(a) omit:
| | | a | Atenolol-GA | ED | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Tenolten 50 | DO | MP NP | | | 30 | 5 | 30 | | |
(c) omit from the column headed “Responsible Person” for the brand “Tenormin”: AP substitute: IX
[14] Schedule 1, Part 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride);
Capsule 25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)
omit:
| | | a | Atomoxetine Amneal | EA | MP | C7876 C7890 | | 56 | 5 | 28 | | |
[15] Schedule 1, Part 1, entry for Atomoxetine in each of the forms: Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)
omit:
| | | a | Atomoxetine Amneal | EA | MP | C7876 C7890 | | 28 | 5 | 28 | | |
[16] Schedule 1, Part 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium)
(a) omit:
| | | a | Atorvastatin Amneal | EF | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Atorvastatin Amneal | EF | MP | | P7598 | 30 | 11 | 30 | | |
[17] Schedule 1, Part 1, entry for Azathioprine in the form Tablet 50 mg
omit:
| | | a | Azathioprine AN | EA | MP NP | | | 100 | 5 | 100 | | |
[18] Schedule 1, Part 1, entry for Benralizumab
omit:
| Injection 30 mg in 1 mL single dose pre-filled syringe | Injection | | Fasenra | AP | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | | D(100) |
[19] Schedule 1, Part 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL
omit:
| | | a | APO-Bimatoprost | TX | AO MP | | | 1 | 5 | 1 | | |
[20] Schedule 1, Part 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg
(a) omit:
| | | a | Beprol 2.5 | DO | MP NP | C5324 | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Bisoprolol AN | EA | MP NP | C5324 | | 28 | 5 | 28 | | |
[21] Schedule 1, Part 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg
(a) omit:
| | | a | Beprol 5 | DO | MP NP | C5324 | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Bisoprolol AN | EA | MP NP | C5324 | | 28 | 5 | 28 | | |
[22] Schedule 1, Part 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg
(a) omit:
| | | a | Beprol 10 | DO | MP NP | C5324 | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Bisoprolol AN | EA | MP NP | C5324 | | 28 | 5 | 28 | | |
[23] Schedule 1, Part 1, entry for Cabergoline in the form Tablet 500 micrograms
substitute:
| | | | Dostinex | PF | MP | C5136 C5137 C5172 C5357 C5398 | P5172 | 2 | 0 | 2 | | |
| | | | | | NP | C5172 | | 2 | 0 | 2 | | |
| | | | | | MP | C5136 C5137 C5172 C5357 C5398 | P5136 P5137 P5357 P5398 | 8 | 5 | 8 | | |
[24] Schedule 1, Part 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg
omit:
| | | a | Candesartan AN | EA | MP NP | | | 30 | 5 | 30 | | |
[25] Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
(a) omit:
| | | a | Asartan HCT 16/12.5 | DO | MP NP | C4374 | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Candesartan HCTZ AN 16/12.5 | EA | MP NP | C4374 | | 30 | 5 | 30 | | |
[26] Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
(a) omit:
| | | a | Asartan HCT 32/12.5 | DO | MP NP | C4374 | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Candesartan HCTZ AN 32/12.5 | EA | MP NP | C4374 | | 30 | 5 | 30 | | |
[27] Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
(a) omit:
| | | a | Asartan HCT 32/25 | DO | MP NP | C4374 | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Candesartan HCTZ AN 32/25 | EA | MP NP | C4374 | | 30 | 5 | 30 | | |
[28] Schedule 1, Part 1, entry for Carvedilol in the form Tablet 3.125 mg
omit:
| | | a | Carvedilol AN | EA | MP NP | C5324 C5394 | | 30 | 0 | 30 | | |
[29] Schedule 1, Part 1, entry for Carvedilol in each of the forms: Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg
omit:
| | | a | Carvedilol AN | EA | MP NP | C5324 C5394 | | 60 | 5 | 60 | | |
[30] Schedule 1, Part 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate)
(a) omit:
| | | a | Cephalexin AN | EA | MP NP MW PDP | | | 20 | 0 | 20 | | |
(b) omit:
| | | a | Cephalexin AN | EA | MP NP MW | | P10412 | 40
CN10412 | 0
CN10412 | 20 | | |
(c) omit:
| | | a | Cephalexin AN | EA | MP | | P4243 | 40
CN4243 | 2
CN4243 | 20 | | |
[31] Schedule 1, Part 1, entry for Cefalexin in the form Capsule 500 mg (as monohydrate)
(a) omit:
| | | a | Cephalexin AN | EA | MP NP MW PDP | | | 20 | 0 | 20 | | |
(b) omit:
| | | a | Cephalexin AN | EA | MP NP MW | | P10410 | 40
CN10410 | 0
CN10410 | 20 | | |
(c) omit:
| | | a | Cephalexin AN | EA | MP | | P6188 | 40
CN6188 | 1
CN6188 | 20 | | |
[32] Schedule 1, Part 1, entry for Celecoxib in the form Capsule 100 mg
omit:
| | | a | Celecoxib AN | EA | MP NP | C4907 C4962 | | 60 | 3 | 60 | | |
[33] Schedule 1, Part 1, entry for Celecoxib in the form Capsule 200 mg
omit:
| | | a | Celecoxib AN | EA | MP NP | C4907 C4962 | | 30 | 3 | 30 | | |
[34] Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 25 mg [Maximum Quantity: 60; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | APO-Ciclosporin | TX | MP | | | 60 | 3 | 30 | | |
[35] Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 25 mg [Maximum Quantity: 120; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | APO-Ciclosporin | TX | MP | | P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764 | 120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764 | 5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764 | 30 | | C(100) |
[36] Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 50 mg [Maximum Quantity: 60; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | APO-Ciclosporin | TX | MP | | | 60 | 3 | 30 | | |
[37] Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 50 mg [Maximum Quantity: 120; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | APO-Ciclosporin | TX | MP | | P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764 | 120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764 | 5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764 | 30 | | C(100) |
[38] Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 100 mg [Maximum Quantity: 60; Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | APO-Ciclosporin | TX | MP | | | 60 | 3 | 30 | | |
[39] Schedule 1, Part 1, entry for Ciclosporin in the form Capsule 100 mg [Maximum Quantity: 120; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | APO-Ciclosporin | TX | MP | | P6631 P6638 P6643 P6660 P6676 P9694 P9695 P9742 P9763 P9764 | 120
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764 | 5
CN6631 CN6638 CN6643 CN6660 CN6676 CN9694 CN9695 CN9742 CN9763 CN9764 | 30 | | C(100) |
[40] Schedule 1, Part 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)
(a) omit:
| | | a | Ciprofloxacin AN | EA | MP NP | C5614 C5615 C5687 C5688 C5689 C5722 C5780 | | 14 | 0 | 14 | | |
(b) omit:
| | | a | Loxip 500 | DO | MP NP | C5614 C5615 C5687 C5688 C5689 C5722 C5780 | | 14 | 0 | 14 | | |
[41] Schedule 1, Part 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)
(a) omit:
| | | a | Ciprofloxacin AN | EA | MP NP | C5614 C5615 C5687 C5688 C5689 C5722 C5780 | | 14 | 0 | 14 | | |
(b) omit:
| | | a | Loxip 750 | DO | MP NP | C5614 C5615 C5687 C5688 C5689 C5722 C5780 | | 14 | 0 | 14 | | |
[42] Schedule 1, Part 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide
omit:
| | | a | Citalopram Actavis | EA | MP NP | C4755 | | 28 | 5 | 28 | | |
[43] Schedule 1, Part 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)
omit:
| | | a | Citalopram Actavis | ED | MP NP | C4755 | | 28 | 5 | 28 | | |
[44] Schedule 1, Part 1, entry for Cladribine in the form Solution for I.V. infusion 10 mg in 10 mL single use vial
omit from the column headed “Responsible Person” for the brand “Leustatin”: JC substitute: IX
[45] Schedule 1, Part 1, entry for Clarithromycin in the form Tablet 250 mg
omit:
[46] Schedule 1, Part 1, entry for Clomipramine
omit from the column headed “Responsible Person” for the brand “Anafranil 25”: SZ substitute: PB
[47] Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit:
| | | | Clopidogrel-GA | EA | MP NP | C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 | | 28 | 5 | 28 | | |
[48] Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit:
| | | | Clopidogrel AN | EA | MP NP | C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 | | 28 | 5 | 28 | | |
[49] Schedule 1, Part 1, entry for Clopidogrel with aspirin
omit:
| | | a | Clopidogrel/Aspirin Actavis 75/100 | EA | MP NP | C5443 C5488 C5517 | | 30 | 5 | 30 | | |
[50] Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg
(a) omit:
| | | a | Cyproterone AN | EA | MP | | P5532 | 20
CN5532 | 5
CN5532 | 20 | | |
(b) omit:
| | | a | Cyproterone AN | EA | MP | | | 100 | 5 | 50 | | |
[51] Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit:
| | | a | Cyproterone AN | EA | MP | | | 50 | 5 | 50 | | |
[52] Schedule 1, Part 1, entry for Dasatinib
substitute:
Dasatinib | Tablet 20 mg | Oral | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| Tablet 50 mg | Oral | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| Tablet 70 mg | Oral | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 60 | 2 | 60 | | |
| | | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 60 | 5 | 60 | | |
| Tablet 100 mg | Oral | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 30 | 2 | 30 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 30 | 2 | 30 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P9367 P9468 P9469 P9549 | 30 | 2 | 30 | | |
| | | a | DASATINIB-TEVA | TB | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 30 | 5 | 30 | | |
| | | a | Sprycel | BQ | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 30 | 5 | 30 | | |
| | | a | TE-DASATINIB | TI | MP | C6702 C6731 C6947 C9197 C9293 C9367 C9468 C9469 C9549 | P6702 P6731 P6947 P9197 P9293 | 30 | 5 | 30 | | |
[53] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | DEFERASIROX-TEVA | TB | MP | C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 | P7385 P8326 P8328 P8329 P9222 P9258 P9302 | 180 | 2 | 30 | | D(100) |
[54] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | DEFERASIROX-TEVA | TB | MP | C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 | P7374 P7375 | 180 | 5 | 30 | | D(100) |
[55] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | DEFERASIROX-TEVA | TB | MP | C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 | P7385 P8326 P8328 P8329 P9222 P9258 P9302 | 180 | 2 | 30 | | D(100) |
[56] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | DEFERASIROX-TEVA | TB | MP | C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 | P7374 P7375 | 180 | 5 | 30 | | D(100) |
[57] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | DEFERASIROX-TEVA | TB | MP | C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 | P7385 P8326 P8328 P8329 P9222 P9258 P9302 | 180 | 2 | 30 | | D(100) |
[58] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | DEFERASIROX-TEVA | TB | MP | C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 | P7374 P7375 | 180 | 5 | 30 | | D(100) |
[59] Schedule 1, Part 1, entry for Desmopressin
omit:
| Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle | Nasal | | Minirin | FP | MP | C5266 | | 5 | 5 | 1 | | |
[60] Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg
(a) omit:
| | | a | Diclofenac Amneal | ED | PDP | | | 100 | 0 | 50 | | |
(b) omit:
| | | a | Diclofenac Amneal | ED | MP NP | | | 100 | 3 | 50 | | |
[61] Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg
(a) omit:
| | | a | Diclofenac Amneal | ED | PDP | | | 50 | 0 | 50 | | |
(b) omit:
| | | a | Diclofenac Amneal | ED | MP NP | | | 50 | 3 | 50 | | |
[62] Schedule 1, Part 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg
(a) omit:
| | | a | Donepezil AN | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
(b) omit:
| | | a | Donepezil AN | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
[63] Schedule 1, Part 1, entry for Dorzolamide
omit:
| | | a | APO-Dorzolamide | TX | AO MP | | | 1 | 5 | 1 | | |
[64] Schedule 1, Part 1, entry for Dorzolamide with timolol
omit:
| | | a | APO-Dorzolamide/Timolol 20/5 | TX | AO | C5038 | | 1 | 5 | 1 | | |
| | | | | | MP | C4343 | | 1 | 5 | 1 | | |
[65] Schedule 1, Part 1, entry for Doxycycline in the form Capsule 100 mg (as hyclate) (containing enteric coated pellets)
omit:
[66] Schedule 1, Part 1, entry for Doxycycline in the form Tablet 50 mg (as hyclate)
omit:
| | | | Doxycycline AN | EA | MP NP | C4475 C4529 C4539 | | 25 | 5 | 25 | | |
[67] Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate)
(a) omit:
(b) omit:
| | | | Doxycycline AN | EA | MP NP | | | 7 | 1 | 7 | | |
(c) omit:
| | | | Doxycycline AN | EA | MP NP | | P4485 | 21 | 0 | 7 | | |
| | | | | | MP NP | | P4485 | 21 | 0 | 21 | | |
(d) omit:
| | | | Doxycycline AN | EA | MP NP | | P4514 | 28 | 0 | 7 | | |
(e) omit:
| | | | Doxycycline AN | EA | MP | | P6200 | 28 | 5 | 7 | | |
[68] Schedule 1, Part 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
omit:
| | | a | Duloxetine AN | EA | MP NP | C5650 | | 28 | 0 | 28 | | |
[69] Schedule 1, Part 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
omit:
| | | a | Duloxetine AN | EA | MP NP | C5650 | | 28 | 5 | 28 | | |
[70] Schedule 1, Part 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg
omit:
| | | a | Enalapril Actavis | ED | MP NP | | | 30 | 5 | 30 | | |
[71] Schedule 1, Part 1, entry for Entecavir in the form Tablet 0.5 mg (as monohydrate)
omit:
| | | a | Entecavir Amneal | EA | MP NP | C4993 C5036 | | 60 | 5 | 30 | | D(100) |
[72] Schedule 1, Part 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)
omit:
| | | a | Entecavir Amneal | EA | MP NP | C5037 C5044 | | 60 | 5 | 30 | | D(100) |
[73] Schedule 1, Part 1, entry for Eplerenone in each of the forms: Tablet 25 mg; and Tablet 50 mg
omit:
| | | a | Eplerenone AN | EA | MP NP | C4937 | | 30 | 5 | 30 | | |
[74] Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
omit:
| | | a | Escitalopram AN | EA | MP NP | C4755 | | 28 | 5 | 28 | | |
[75] Schedule 1, Part 1, entry for Esomeprazole in the form Capsule (enteric) 20 mg (as magnesium)
substitute:
Esomeprazole | Capsule (enteric) 20 mg (as magnesium) | Oral | | Noxicid Caps | AL | MP | C8774 C8775 C8776 C8780 C8827 C11310 | P8774 P8775 | 30 | 1 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8827 | P8774 P8775 | 30 | 1 | 30 | | |
| | | | | | MP | C8774 C8775 C8776 C8780 C8827 C11310 | P8776 P8780 P8827 | 30 | 5 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8827 | P8776 P8780 P8827 | 30 | 5 | 30 | | |
| | | | | | MP | C8774 C8775 C8776 C8780 C8827 C11310 | P11310 | 60 | 5 | 30 | | |
[76] Schedule 1, Part 1, entry for Esomeprazole in the form Capsule (enteric) 40 mg (as magnesium)
substitute:
| Capsule (enteric) 40 mg (as magnesium) | Oral | | Noxicid Caps | AL | MP | C8777 C8778 C8902 C11370 | P8902 | 30 | 1 | 30 | | |
| | | | | | NP | C8777 C8778 C8902 | P8902 | 30 | 1 | 30 | | |
| | | | | | MP | C8777 C8778 C8902 C11370 | P8777 P8778 | 30 | 5 | 30 | | |
| | | | | | NP | C8777 C8778 C8902 | P8777 P8778 | 30 | 5 | 30 | | |
| | | | | | MP | C8777 C8778 C8902 C11370 | P11370 | 60 | 5 | 30 | | |
[77] Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C12288
(b) omit from the column headed “Circumstances”: C12320
(c) insert in numerical order in the column headed “Circumstances”: C12434 C12457
(d) omit from the column headed “Purposes”: P12288
(e) omit from the column headed “Purposes”: P12320
(f) insert in numerical order in the column headed “Purposes”: P12434 P12457
[78] Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12288
(b) omit from the column headed “Circumstances”: C12320
(c) insert in numerical order in the column headed “Circumstances”: C12434 C12457
[79] Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C12288
(b) omit from the column headed “Circumstances”: C12320
(c) insert in numerical order in the column headed “Circumstances”: C12434 C12457
(d) omit from the column headed “Purposes”: P12288
(e) omit from the column headed “Purposes”: P12320
(f) insert in numerical order in the column headed “Purposes”: P12434 P12457
[80] Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12288
(b) omit from the column headed “Circumstances”: C12320
(c) insert in numerical order in the column headed “Circumstances”: C12434 C12457
[81] Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum
Quantity: 1; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C12288
(b) omit from the column headed “Circumstances”: C12320
(c) insert in numerical order in the column headed “Circumstances”: C12434 C12457
(d) omit from the column headed “Purposes”: P12288
(e) omit from the column headed “Purposes”: P12320
(f) insert in numerical order in the column headed “Purposes”: P12434 P12457
[82] Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum
Quantity: 1; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12288
(b) omit from the column headed “Circumstances”: C12320
(c) insert in numerical order in the column headed “Circumstances”: C12434 C12457
[83] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 125 mg
(a) omit:
| | | a | Auro-Famciclovir 125 | DO | MP NP | C5937 | | 40 | 1 | 40 | | |
(b) omit:
| | | a | Famciclovir AN | EA | MP NP | C5937 | | 40 | 1 | 40 | | |
[84] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 20; Number of Repeats: 1]
(a) omit:
| | | a | Famciclovir AN | EA | MP NP | C5937 C5951 C5971 | P5937 | 20 | 1 | 20 | | |
(b) omit from the column headed “Circumstances” for the brand “Famciclovir-GA”: C5971
[85] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 21; Number of Repeats: 0]
(a) omit:
| | | a | Auro-Famciclovir 250 | DO | MP NP | C5951 C5971 | P5951 | 21 | 0 | 21 | | |
(b) omit:
| | | a | Famciclovir AN | EA | MP NP | C5937 C5951 C5971 | P5951 | 21 | 0 | 21 | | |
(c) omit from the column headed “Circumstances” for the brand “Famciclovir-GA”: C5971
[86] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a) omit:
| | | a | Auro-Famciclovir 250 | DO | MP NP | C5951 C5971 | P5971 | 56 | 5 | 56 | | |
(b) omit:
| | | a | Famciclovir AN | EA | MP NP | C5937 C5951 C5971 | P5971 | 56 | 5 | 56 | | |
(c) omit:
| | | a | Famciclovir-GA | ED | MP NP | C5937 C5951 C5971 | P5971 | 56 | 5 | 56 | | |
[87] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 500 mg
(a) omit:
| | | a | Auro-Famciclovir 500 | DO | MP NP | C5943 C5947 C5948 C5949 C5954 | P5943 | 30 | 0 | 30 | | |
| | | a | Famciclovir AN | EA | MP NP | C5943 C5947 C5948 C5949 C5954 | P5943 | 30 | 0 | 30 | | |
(b) omit:
| | | a | Auro-Famciclovir 500 | DO | MP NP | C5943 C5947 C5948 C5949 C5954 | P5947 P5948 P5949 P5954 | 56 | 5 | 56 | | |
(c) omit:
| | | a | Famciclovir AN | EA | MP NP | C5943 C5947 C5948 C5949 C5954 | P5947 P5948 P5949 P5954 | 56 | 5 | 56 | | |
[88] Schedule 1, Part 1, entry for Famotidine in the form Tablet 20 mg
(a) omit from the column headed “Schedule Equivalent” for the brand “Ausfam 20”: a
(b) omit:
| | | a | Famotidine AN | EA | MP NP | | | 60 | 5 | 60 | | |
| | | a | GenRx Famotidine | GX | MP NP | | | 60 | 5 | 60 | | |
[89] Schedule 1, Part 1, entry for Famotidine in the form Tablet 40 mg
(a) omit from the column headed “Schedule Equivalent” for the brand “Ausfam 40”: a
(b) omit:
| | | a | Famotidine AN | EA | MP NP | | | 30 | 5 | 30 | | |
| | | a | GenRx Famotidine | GX | MP NP | | | 30 | 5 | 30 | | |
[90] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.063 mg [Maximum Quantity: 5; Number of Repeats: 0]
omit:
| | | | Dutran 12 | EA | MP NP | C10745 C10747 C10751 C11696 | P10745 P10747 P10751 | 5 | 0 | 5 | | |
[91] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 2.063 mg [Maximum Quantity: 10; Number of Repeats: 0]
(a) omit:
| | | | Dutran 12 | EA | MP NP | C10745 C10747 C10751 C11696 | P11696 | 10 | 0 | 5 | | |
(b) omit from the column headed “Brand” for the brand “Fenpatch 12”: Fenpatch 12
(c) omit from the column headed “Responsible Person” for the brand “Fenpatch 12”: ZP
[92] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 4.125 mg [Maximum Quantity: 5; Number of Repeats: 0]
omit:
| | | | Dutran 25 | EA | MP NP | C10745 C10747 C10751 C11696 | P10745 P10747 P10751 | 5 | 0 | 5 | | |
[93] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 4.125 mg [Maximum Quantity: 10; Number of Repeats: 0]
(a) omit:
| | | | Dutran 25 | EA | MP NP | C10745 C10747 C10751 C11696 | P11696 | 10 | 0 | 5 | | |
(b) omit from the column headed “Brand” for the brand “Fenpatch 25”: Fenpatch 25
(c) omit from the column headed “Responsible Person” for the brand “Fenpatch 25”: ZP
[94] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 8.25 mg [Maximum Quantity: 5; Number of Repeats: 0]
omit:
| | | | Dutran 50 | EA | MP NP | C10745 C10747 C10751 C11696 | P10745 P10747 P10751 | 5 | 0 | 5 | | |
[95] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 8.25 mg [Maximum Quantity: 10; Number of Repeats: 0]
(a) omit:
| | | | Dutran 50 | EA | MP NP | C10745 C10747 C10751 C11696 | P11696 | 10 | 0 | 5 | | |
(b) omit from the column headed “Brand” for the brand “Fenpatch 50”: Fenpatch 50
(c) omit from the column headed “Responsible Person” for the brand “Fenpatch 50”: ZP
[96] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 12.375 mg [Maximum Quantity: 5; Number of Repeats: 0]
omit:
| | | | Dutran 75 | EA | MP NP | C10745 C10747 C10751 C11696 | P10745 P10747 P10751 | 5 | 0 | 5 | | |
[97] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 12.375 mg [Maximum Quantity: 10; Number of Repeats: 0]
(a) omit:
| | | | Dutran 75 | EA | MP NP | C10745 C10747 C10751 C11696 | P11696 | 10 | 0 | 5 | | |
(b) omit from the column headed “Brand” for the brand “Fenpatch 75”: Fenpatch 75
(c) omit from the column headed “Responsible Person” for the brand “Fenpatch 75”: ZP
[98] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 16.5 mg [Maximum Quantity: 5; Number of Repeats: 0]
omit:
| | | | Dutran 100 | EA | MP NP | C10745 C10747 C10751 C11696 | P10745 P10747 P10751 | 5 | 0 | 5 | | |
[99] Schedule 1, Part 1, entry for Fentanyl in the form Transdermal patch 16.5 mg [Maximum Quantity: 10; Number of Repeats: 0]
(a) omit:
| | | | Dutran 100 | EA | MP NP | C10745 C10747 C10751 C11696 | P11696 | 10 | 0 | 5 | | |
(b) omit from the column headed “Brand” for the brand “Fenpatch 100”: Fenpatch 100
(c) omit from the column headed “Responsible Person” for the brand “Fenpatch 100”: ZP
[100] Schedule 1, Part 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
(a) omit:
| | | a | Fluoxetine AN | EA | MP NP | C4755 C6277 | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Fluoxetine-GA | ED | MP NP | C4755 C6277 | | 28 | 5 | 28 | | |
[101] Schedule 1, Part 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg
omit:
| | | a | Fluvoxamine AN | ED | MP NP | C4755 C6277 | | 30 | 5 | 30 | | |
| | | a | Fluvoxamine GA | EA | MP NP | C4755 C6277 | | 30 | 5 | 30 | | |
[102] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 300 I.U. in 0.5 mL multi-dose cartridge
substitute:
| Injection 300 I.U. in 0.5 mL multi-dose cartridge | Injection | a | Ovaleap | TT | MP | C5027 | | 2 | 0 | 1 | | C(100) |
| | | a | Gonal-f Pen | SG | MP | C5027 | | 2 | 0 | 1 | | C(100) |
| | | a | Ovaleap | TT | MP | C6257 C6321 | | 3 | 5 | 1 | | |
| | | a | Gonal-f Pen | SG | MP | C6257 C6321 | | 3 | 5 | 1 | | |
[103] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 450 I.U. in 0.75 mL multi-dose cartridge
substitute:
| Injection 450 I.U. in 0.75 mL multi-dose cartridge | Injection | a | Ovaleap | TT | MP | C5027 | | 2 | 0 | 1 | | C(100) |
| | | a | Gonal-f Pen | SG | MP | C5027 | | 2 | 0 | 1 | | C(100) |
| | | a | Ovaleap | TT | MP | C6257 C6321 | | 3 | 5 | 1 | | |
| | | a | Gonal-f Pen | SG | MP | C6257 C6321 | | 3 | 5 | 1 | | |
[104] Schedule 1, Part 1, entry for Follitropin alfa in the form Injection 900 I.U. in 1.5 mL multi-dose cartridge
substitute:
| Injection 900 I.U. in 1.5 mL multi-dose cartridge | Injection | a | Ovaleap | TT | MP | C6257 C6321 | | 2 | 5 | 1 | | |
| | | a | Gonal-f Pen | SG | MP | C6257 C6321 | | 2 | 5 | 1 | | |
| | | a | Ovaleap | TT | MP | C5027 | | 5 | 0 | 1 | | C(100) |
| | | a | Gonal-f Pen | SG | MP | C5027 | | 5 | 0 | 1 | | C(100) |
[105] Schedule 1, Part 1, entry for Fosinopril with hydrochlorothiazide
omit:
| | | a | Fosinopril/HCT Actavis 20/12.5 | EA | MP NP | C4389 | | 30 | 5 | 30 | | |
[106] Schedule 1, Part 1, entry for Fulvestrant
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | FULVESTRANT ACCORD | OC | MP | C11473 | | 2 | 5 | 2 | | |
(b) insert in the column headed “Schedule Equivalent” for the brand “Fulvestrant Sandoz”: a
[107] Schedule 1, Part 1, entry for Gabapentin in each of the forms: Capsule 300 mg; and Capsule 400 mg
omit:
| | | a | Gabapentin AN | EA | MP NP | C4928 | | 100 | 5 | 100 | | |
[108] Schedule 1, Part 1, entry for Gabapentin in the form Tablet 800 mg
omit:
| | | a | Gabapentin AN | EA | MP NP | C4928 | | 100 | 5 | 100 | | |
[109] Schedule 1, Part 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)
(a) omit:
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 | | |
(b) omit:
| | | a | Galantamine AN SR | EA | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 | | |
| | | | | | NP | C10108 | | 28 | 5 | 28 | | |
[110] Schedule 1, Part 1, entry for Glimepiride in each of the forms: Tablet 1 mg; Tablet 2 mg; Tablet 3 mg; and Tablet 4 mg
omit:
| | | a | Glimepiride AN | EA | MP NP | | | 30 | 5 | 30 | | |
[111] Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C12354 C12366
(b) insert in numerical order in the column headed “Circumstances”: C12401 C12468
[112] Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12354 C12366
(b) insert in numerical order in the column headed “Circumstances”: C12401 C12468
(c) omit from the column headed “Purposes”: P12354 P12366
(d) insert in numerical order in the column headed “Purposes”: P12401 P12468
[113] Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C12354 C12366
(b) insert in numerical order in the column headed “Circumstances”: C12401 C12468
[114] Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C12354 C12366
(b) insert in numerical order in the column headed “Circumstances”: C12401 C12468
(c) omit from the column headed “Purposes”: P12354 P12366
(d) insert in numerical order in the column headed “Purposes”: P12401 P12468
[115] Schedule 1, Part 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate in the form Oral liquid 250 mL, 30 (KetoVie 4:1)
insert:
| Oral liquid 250 mL, 30 (KetoVie Peptide 4:1) | Oral | | KetoVie Peptide 4:1 | QH | MP NP | C12459 | | 6 | 5 | 1 | | |
[116] Schedule 1, Part 1, entry for Hydromorphone in the form Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL
substitute:
| Oral solution containing hydromorphone hydrochloride
1 mg per mL, 473 mL | Oral | a | Hikma | LM | PDP | C10859 | | 1 | 0 | 1 | | |
| | | | | | MP NP | C10764 C10770 C10777 C11697 | P10764 P10770 P10777 | 1 | 0 | 1 | | |
| | | a | Hydromorphone hydrochloride oral solution, USP (Medsurge) | DZ | PDP | C10859 | | 1 | 0 | 1 | | |
| | | | | | MP NP | C10764 C10770 C10777 C11697 | P10764 P10770 P10777 | 1 | 0 | 1 | | |
| | | a | Hikma | LM | MP NP | C10764 C10770 C10777 C11697 | P11697 | 1 | 1 | 1 | | |
| | | a | Hydromorphone hydrochloride oral solution, USP (Medsurge) | DZ | MP NP | C10764 C10770 C10777 C11697 | P11697 | 1 | 1 | 1 | | |
[117] Schedule 1, Part 1, entry for Hydroxychloroquine
omit:
| | | a | Hydroxychloroquine AN | EA | MP | C10417 C10418 C10419 C10420 | | 100 | 1 | 100 | | |
| | | | | | NP | C10419 C10420 | | 100 | 1 | 100 | | |
[118] Schedule 1, Part 1, entry for Imipramine
omit:
| Tablet containing imipramine hydrochloride 25 mg USP | Oral | | Imipramine (Leading) | QY | MP NP | | | 50 | 2 | 100 | | |
[119] Schedule 1, Part 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
omit:
| | | a | INDAPAMIDE AN SR | EA | MP NP | | | 90 | 1 | 90 | | |
[120] Schedule 1, Part 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg
omit:
| | | a | Indapamide AN | EA | MP NP | | | 90 | 1 | 90 | | |
[121] Schedule 1, Part 1, entry for Irbesartan in the form Tablet 75 mg
omit:
| | | a | Irbesartan Actavis 75 | ED | MP NP | | | 30 | 5 | 30 | | |
[122] Schedule 1, Part 1, entry for Irbesartan in the form Tablet 150 mg
omit:
| | | a | Irbesartan Actavis 150 | ED | MP NP | | | 30 | 5 | 30 | | |
| | | a | Irbesartan AMNEAL | EF | MP NP | | | 30 | 5 | 30 | | |
| | | a | Irbesartan AN | EA | MP NP | | | 30 | 5 | 30 | | |
[123] Schedule 1, Part 1, entry for Irbesartan in the form Tablet 300 mg
omit:
| | | a | Irbesartan Actavis 300 | ED | MP NP | | | 30 | 5 | 30 | | |
| | | a | Irbesartan AMNEAL | EF | MP NP | | | 30 | 5 | 30 | | |
[124] Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
omit:
| | | a | Irbesartan HCT Actavis 150/12.5 | ED | MP NP | C4374 | | 30 | 5 | 30 | | |
| | | a | Irbesartan HCTZ AMNEAL | EF | MP NP | C4374 | | 30 | 5 | 30 | | |
[125] Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
omit:
| | | a | Irbesartan HCT Actavis 300/12.5 | ED | MP NP | C4374 | | 30 | 5 | 30 | | |
| | | a | Irbesartan HCTZ AMNEAL | EF | MP NP | C4374 | | 30 | 5 | 30 | | |
[126] Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-25 mg
omit:
| | | a | Irbesartan HCT Actavis 300/25 | ED | MP NP | C4374 | | 30 | 5 | 30 | | |
| | | a | Irbesartan HCTZ AMNEAL | EF | MP NP | C4374 | | 30 | 5 | 30 | | |
[127] Schedule 1, Part 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; and Capsule 20 mg
omit:
| | | a | Isotretinoin AN | EA | MP | C5224 | | 60 | 3 | 60 | | |
[128] Schedule 1, Part 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
omit:
| | | a | Lamotrigine AN | EA | MP NP | C11081 | | 56 | 5 | 56 | | |
[129] Schedule 1, Part 1, after entry for Lamotrigine in the form Tablet 200 mg
insert:
Lanadelumab | Injection 300 mg in 2 mL single use pre-filled syringe | Injection | | Takhzyro | TK | MP | C12416 C12435 C12464 C12467 | | 1 | 5 | 1 | | |
[130] Schedule 1, Part 1, entry for Latanoprost
omit:
| | | a | Latanoprost Actavis | EA | AO MP | | | 1 | 5 | 1 | | |
[131] Schedule 1, Part 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg
omit:
| | | a | Leflunomide AN | EA | MP | C5681 | | 30 | 5 | 30 | | |
[132] Schedule 1, Part 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
omit:
[133] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 250 mg
(a) omit:
| | | a | Kerron 250 | DO | MP NP | C11116 | | 60 | 5 | 60 | | |
(b) omit:
| | | a | Levetiracetam AN | EA | MP NP | C11116 | | 60 | 5 | 60 | | |
[134] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 500 mg
(a) omit:
| | | a | Kerron 500 | DO | MP NP | C11116 | | 60 | 5 | 60 | | |
(b) omit:
| | | a | Levetiracetam AN | EA | MP NP | C11116 | | 60 | 5 | 60 | | |
[135] Schedule 1, Part 1, entry for Levetiracetam in the form Tablet 1 g
(a) omit:
| | | a | Kerron 1000 | DO | MP NP | C11116 | | 60 | 5 | 60 | | |
(b) omit:
| | | a | Levetiracetam AN | EA | MP NP | C11116 | | 60 | 5 | 60 | | |
[136] Schedule 1, Part 1, entry for Lisinopril in the form Tablet 5 mg
(a) omit:
| | | a | Auro-Lisinopril 5 | DO | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Lisinopril AN | EA | MP NP | | | 30 | 5 | 30 | | |
(c) omit from the column headed “Responsible Person” for the brand “Zestril”: AP substitute: IX
[137] Schedule 1, Part 1, entry for Lisinopril in the form Tablet 10 mg
(a) omit:
| | | a | Auro-Lisinopril 10 | DO | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Lisinopril AN | EA | MP NP | | | 30 | 5 | 30 | | |
(c) omit from the column headed “Responsible Person” for the brand “Zestril”: AP substitute: IX
[138] Schedule 1, Part 1, entry for Lisinopril in the form Tablet 20 mg
(a) omit:
| | | a | Auro-Lisinopril 20 | DO | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Lisinopril AN | EA | MP NP | | | 30 | 5 | 30 | | |
(c) omit from the column headed “Responsible Person” for the brand “Zestril”: AP substitute: IX
[139] Schedule 1, Part 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
(a) omit:
| | | a | LaxaCon | EA | MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | | C(100) |
(b) omit:
| | | a | LaxaCon | EA | MP NP | C4576 C4577 C4580 C4596 C4601 C6171 | P4576 P4577 P4580 P4596 P4601 | 1 | 5 | 1 | | |
(c) omit:
| | | a | LaxaCon | EA | MP NP | C4576 C4577 C4580 C4596 C4601 C6171 | P6171 | 2 | 3 | 1 | | |
[140] Schedule 1, Part 1, entry for Meloxicam in the form Tablet 7.5 mg
(a) omit:
| | | | Meloxiauro 7.5 | DO | MP NP | C4907 C4962 | | 30 | 3 | 30 | | |
(b) omit:
| | | | Meloxicam AN | EA | MP NP | C4907 C4962 | | 30 | 3 | 30 | | |
(c) omit:
| | | | Meloxicam-GA | ED | MP NP | C4907 C4962 | | 30 | 3 | 30 | | |
[141] Schedule 1, Part 1, entry for Meloxicam in the form Tablet 15 mg
(a) omit:
| | | | Meloxiauro 15 | DO | MP NP | C4907 C4962 | | 30 | 3 | 30 | | |
(b) omit:
| | | | Meloxicam AN | EA | MP NP | C4907 C4962 | | 30 | 3 | 30 | | |
(c) omit:
| | | | Meloxicam-GA | ED | MP NP | C4907 C4962 | | 30 | 3 | 30 | | |
[142] Schedule 1, Part 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
omit:
| | | | Methaccord | EA | MP | | | See Note 3 | See Note 3 | 1 | | PB(100) |
| | | | | | MP | | P6276 | See Note 3 | See Note 3 | 1 | | PB(100) |
[143] Schedule 1, Part 1, entry for Methylphenidate in each of the forms: Tablet containing methylphenidate hydrochloride 18 mg (extended release); Tablet containing methylphenidate hydrochloride 27 mg (extended release); Tablet containing methylphenidate hydrochloride 36 mg (extended release); and Tablet containing methylphenidate hydrochloride 54 mg (extended release)
(a) insert in the column headed “Schedule Equivalent” for the brand “Concerta”: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| | | a | Methylphenidate XR ARX | XT | MP NP | C10717 | | 30 | 5 | 30 | | |
[144] Schedule 1, Part 1, entry for Metoclopramide in the form Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)
(a) omit:
| | | a | Metoclopramide AN | EA | MP NP MW PDP | | | 25 | 0 | 25 | | |
(b) omit:
| | | a | Metoclopramide AN | EA | MP NP | | P11683 | 100 | 5 | 25 | | |
[145] Schedule 1, Part 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
omit:
| | | a | Metoprolol AN | EA | MP NP | | | 100 | 5 | 100 | | |
[146] Schedule 1, Part 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
omit:
| | | a | Metoprolol AN | EA | MP NP | | | 60 | 5 | 60 | | |
[147] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 15 mg
omit:
| | | a | Mirtazapine AN | EA | MP NP | C5650 | | 30 | 5 | 30 | | |
[148] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)
omit:
| | | a | Milivin OD 15 | DO | MP NP | C5650 | | 30 | 5 | 30 | | |
[149] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg
omit:
| | | a | Mirtazapine AN | EA | MP NP | C5650 | | 30 | 5 | 30 | | |
[150] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)
omit:
| | | a | Milivin OD 30 | DO | MP NP | C5650 | | 30 | 5 | 30 | | |
[151] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg
omit:
| | | a | Mirtazapine AN | EA | MP NP | C5650 | | 30 | 5 | 30 | | |
[152] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)
omit:
| | | a | Milivin OD 45 | DO | MP NP | C5650 | | 30 | 5 | 30 | | |
[153] Schedule 1, Part 1, entry for Modafinil in the form Tablet 100 mg
omit:
| | | a | Modafinil AN | EA | MP | C10935 C10968 C10970 | | 120 | 5 | 60 | | |
[154] Schedule 1, Part 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
(a) omit:
| | | a | Auro-Montelukast Tabs 4 | DO | MP NP | C6666 | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Montelukast AN | EA | MP NP | C6666 | | 28 | 5 | 28 | | |
[155] Schedule 1, Part 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
(a) omit:
| | | a | Auro-Montelukast Tabs 5 | DO | MP NP | C6674 C7781 | | 28 | 5 | 28 | | |
(b) omit:
| | | a | Montelukast AN | EA | MP NP | C6674 C7781 | | 28 | 5 | 28 | | |
[156] Schedule 1, Part 1, entry for Morphine in the form Tablet containing morphine sulfate pentahydrate 10 mg (controlled release)
(a) omit:
| | | a | Morphine MR AN | EA | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 | | |
(b) omit:
| | | a | Morphine MR AN | EA | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 | | |
[157] Schedule 1, Part 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate pentahydrate 30 mg (controlled release); Tablet containing morphine sulfate pentahydrate 60 mg (controlled release); and Tablet containing morphine sulfate pentahydrate 100 mg (controlled release)
(a) omit:
| | | a | Morphine MR AN | EA | MP NP | C10748 C10752 C10755 C11753 | P10748 P10752 P10755 | 28 | 0 | 28 | | |
(b) omit:
| | | a | Morphine MR AN | EA | MP NP | C10748 C10752 C10755 C11753 | P11753 | 56 | 0 | 28 | | |
[158] Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg
(a) omit:
| | | a | Mycophenolate AN | EA | MP | | | 150 | 5 | 50 | | |
(b) omit:
| | | a | Mycophenolate AN | EA | MP | | P5554 P5795 P9691 P9693 | 300
CN5554 CN5795 CN9691 CN9693 | 5
CN5554 CN5795 CN9691 CN9693 | 50 | | C(100) |
[159] Schedule 1, Part 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
(a) omit:
| | | a | Nevirapine XR APOTEX | TX | MP NP | C4454 C4526 | | 60 | 5 | 30 | | D(100) |
(b) omit from the column headed “Schedule Equivalent” for the brand “Viramune XR”: a
[160] Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; and Tablet 5 mg
omit:
| | | a | Olanzapine AN | EA | MP NP | C5856 C5869 | | 28 | 5 | 28 | | |
[161] Schedule 1, Part 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)
omit:
| | | | Olanzapine AN ODT | EA | MP NP | C5856 C5869 | | 28 | 5 | 28 | | |
[162] Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 7.5 mg; and Tablet 10 mg
omit:
| | | a | Olanzapine AN | EA | MP NP | C5856 C5869 | | 28 | 5 | 28 | | |
[163] Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 10 mg (orally disintegrating); Tablet 15 mg (orally disintegrating); and Tablet 20 mg (orally disintegrating)
omit:
| | | | Olanzapine AN ODT | EA | MP NP | C5856 C5869 | | 28 | 5 | 28 | | |
[164] Schedule 1, Part 1, entry for Olmesartan in each of the forms: Tablet containing olmesartan medoxomil 20 mg; and Tablet containing olmesartan medoxomil 40 mg
omit:
| | | a | Olmesartan AN | EA | MP NP | | | 30 | 5 | 30 | | |
[165] Schedule 1, Part 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg
omit:
| | | a | Olmesartan HCT AN 20/12.5 | EA | MP NP | C4374 | | 30 | 5 | 30 | | |
[166] Schedule 1, Part 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg
omit:
| | | a | Olmesartan HCT AN 40/12.5 | EA | MP NP | C4374 | | 30 | 5 | 30 | | |
[167] Schedule 1, Part 1, entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg
omit:
| | | a | Olmesartan HCT AN 40/25 | EA | MP NP | C4374 | | 30 | 5 | 30 | | |
[168] Schedule 1, Part 1, entry for Omeprazole in the form Tablet 10 mg (as magnesium)
omit from the column headed “Responsible Person” for the brand “Losec Tablets”: AP substitute: PB
[169] Schedule 1, Part 1, entry for Omeprazole in the form Tablet 20 mg
(a) omit:
| | | | Omeprazole AN | EA | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P8774 P8775 | 30 | 1 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8866 | P8774 P8775 | 30 | 1 | 30 | | |
(b) omit:
| | | | Omeprazole AN | EA | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P8776 P8780 P8866 | 30 | 5 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | 30 | | |
(c) omit:
| | | | Omeprazole AN | EA | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P11310 | 60 | 5 | 30 | | |
[170] Schedule 1, Part 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium)
(a) omit from the column headed “Responsible Person” for the brand “Losec Tablets” (all instances): AP substitute: PB
(b) omit from the column headed “Responsible Person” for the brand “Omepral” (all instances): ZA substitute: FQ
[171] Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg
omit:
| | | | Zilfojim ODT 4 | DO | MP NP | C10498 | | 10 | 1 | 10 | | |
[172] Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg
omit:
| | | | Zilfojim ODT 8 | DO | MP NP | C10498 | | 10 | 1 | 10 | | |
[173] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
omit:
| | | a | Pantoprazole AN | EA | MP NP | C5444 C5512 C5529 | | 30 | 5 | 30 | | |
[174] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
(a) omit:
| | | a | Pantoprazole Actavis | ED | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P8774 P8775 | 30 | 1 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8866 | P8774 P8775 | 30 | 1 | 30 | | |
(b) omit:
| | | a | Pantoprazole Actavis | ED | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P8776 P8780 P8866 | 30 | 5 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | 30 | | |
(c) omit:
| | | a | Pantoprazole Actavis | ED | MP | C8774 C8775 C8776 C8780 C8866 C11310 | P11310 | 60 | 5 | 30 | | |
[175] Schedule 1, Part 1, entry for Paroxetine
omit:
| | | a | Roxet 20 | DO | MP NP | C4755 C6277 C6636 | | 30 | 5 | 30 | | |
[176] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
| | | | Perindopril Actavis 2 | EA | MP NP | | | 30 | 5 | 30 | | |
| | | | Perindopril AN | EF | MP NP | | | 30 | 5 | 30 | | |
[177] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit:
| | | | Perindopril Actavis 4 | ED | MP NP | | | 30 | 5 | 30 | | |
| | | | Perindopril AN | EF | MP NP | | | 30 | 5 | 30 | | |
[178] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit:
| | | | Perindopril Actavis 8 | ED | MP NP | | | 30 | 5 | 30 | | |
| | | | Perindopril AN | EF | MP NP | | | 30 | 5 | 30 | | |
[179] Schedule 1, Part 1, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
omit:
| | | | Perindopril and Indapamide AN 4/1.25 | EF | MP NP | C4375 | | 30 | 5 | 30 | | |
| | | | Perindopril Combi Actavis 4/1.25 | ED | MP NP | C4375 | | 30 | 5 | 30 | | |
[180] Schedule 1, Part 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)
omit:
| | | a | Pioglitazone AN | EA | MP NP | C4363 C4364 C4388 | | 28 | 5 | 28 | | |
[181] Schedule 1, Part 1, entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms
omit:
| | | a | Pramipexole AN | EA | MP NP | C5363 | | 30 | 0 | 30 | | |
[182] Schedule 1, Part 1, entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms
omit:
| | | a | Pramipexole AN | EA | MP NP | C5363 | | 100 | 5 | 100 | | |
[183] Schedule 1, Part 1, entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 1 mg
omit:
| | | a | Pramipexole AN | EA | MP NP | C5363 | | 100 | 5 | 100 | | |
[184] Schedule 1, Part 1, entry for Pravastatin in each of the forms: Tablet containing pravastatin sodium 10 mg; Tablet containing pravastatin sodium 20 mg; Tablet containing pravastatin sodium 40 mg; and Tablet containing pravastatin sodium 80 mg
(a) omit:
| | | a | Pravastatin AN | EA | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Pravastatin AN | EA | MP | | P7598 | 30 | 11 | 30 | | |
[185] Schedule 1, Part 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg
omit:
| | | a | Pregabalin AMNEAL | EA | MP NP | C4172 | | 56 | 5 | 56 | | |
[186] Schedule 1, Part 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
omit:
| | | a | Prochlorperazine AN | EA | MP NP PDP | | | 25 | 0 | 25 | | |
[187] Schedule 1, Part 1, entry for Propranolol in each of the forms: Tablet containing propranolol hydrochloride 10 mg; and Tablet containing propranolol hydrochloride 40 mg
omit from the column headed “Responsible Person” for the brand “Inderal”: AP substitute: IX
[188] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit:
| | | a | Quetiapine AN | EA | MP NP | C7893 C7916 C7927 | | 60 | 0 | 60 | | |
[189] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit:
| | | a | Quetiapine Actavis 100 | ED | MP NP | C4246 C5611 C5639 | | 90 | 5 | 90 | | |
[190] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
omit:
| | | a | Quetiapine Actavis 200 | ED | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
| | | a | Quetiapine AN | EA | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[191] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
omit:
| | | a | Quetiapine Actavis 300 | ED | MP NP | C4246 C5611 C5639 | | 60 | 5 | 60 | | |
[192] Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
omit:
| | | a | Rabeprazole AN | EA | MP NP | C5444 C5512 | | 28 | 5 | 28 | | |
[193] Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a) omit:
| | | a | Rabeprazole AN | EA | MP | C8774 C8775 C8776 C8780 C11310 | P8774 P8775 | 30 | 1 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 | P8774 P8775 | 30 | 1 | 30 | | |
(b) omit:
| | | a | Rabeprazole AN | EA | MP | C8774 C8775 C8776 C8780 C11310 | P8776 P8780 | 30 | 5 | 30 | | |
| | | | | | NP | C8774 C8775 C8776 C8780 | P8776 P8780 | 30 | 5 | 30 | | |
(c) omit:
| | | a | Rabeprazole AN | EA | MP | C8774 C8775 C8776 C8780 C11310 | P11310 | 60 | 5 | 30 | | |
[194] Schedule 1, Part 1, entry for Raloxifene
omit:
| | | a | Raloxifene AMNEAL | ED | MP NP | C6314 | | 28 | 5 | 28 | | |
| | | a | Raloxifene AN | EA | MP NP | C6314 | | 28 | 5 | 28 | | |
[195] Schedule 1, Part 1, entry for Ramipril in the form Capsule 10 mg
omit:
[196] Schedule 1, Part 1, entry for Ramipril in each of the forms: Tablet 2.5 mg; Tablet 5 mg; and Tablet 10 mg
omit:
[197] Schedule 1, Part 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
omit:
| | | a | Ranitidine AN | EA | MP NP MW | | | 60 | 5 | 60 | | |
[198] Schedule 1, Part 1, entry for Ribavirin
insert as first entry:
| Tablet 200 mg | Oral | | Ibavyr | IX | MP NP | C5957 | | 200 | 2 | 100 | | |
[199] Schedule 1, Part 1, after entry for Riociguat in the form Tablet 2.5 mg
insert:
Ripretinib | Tablet 50 mg | Oral | | Qinlock | TS | MP | C12440 C12455 | | 90 | 1 | 90 | | |
[200] Schedule 1, Part 1, entry for Risedronic acid in the form Tablet containing risedronate sodium 35 mg
omit:
| | | a | Risedronate AN | EA | MP NP | C6310 C6323 C6327 | | 4 | 5 | 4 | | |
[201] Schedule 1, Part 1, entry for Risperidone in the form Tablet 0.5 mg
(a) omit:
| | | a | Risperidone AMNEAL | EF | MP NP | C5903 C6898 C6899 C10020 C10021 | P6898 P6899 P10020 P10021 | 60 | 2 | 60 | | |
(b) omit:
| | | a | Risperidone AMNEAL | EF | MP NP | C5903 C6898 C6899 C10020 C10021 | P5903 | 60 | 5 | 60 | | |
[202] Schedule 1, Part 1, entry for Risperidone in the form Tablet 1 mg
(a) omit:
| | | a | Risperidone AMNEAL | EF | MP NP | C4246 C5907 C6898 C6899 C10020 C10021 | P6898 P6899 P10020 P10021 | 60 | 2 | 60 | | |
(b) omit:
| | | a | Risperidone AMNEAL | EF | MP NP | C4246 C5907 C6898 C6899 C10020 C10021 | P4246 P5907 | 60 | 5 | 60 | | |
[203] Schedule 1, Part 1, entry for Risperidone in the form Tablet 2 mg
(a) omit:
| | | a | Risperidone AMNEAL | EF | MP NP | C4246 C5907 C6897 C6938 | P6897 P6938 | 60 | 2 | 60 | | |
(b) omit:
| | | a | Risperidone AMNEAL | EF | MP NP | C4246 C5907 C6897 C6938 | P4246 P5907 | 60 | 5 | 60 | | |
[204] Schedule 1, Part 1, entry for Risperidone in each of the forms: Tablet 3 mg; and Tablet 4 mg
omit:
| | | a | Risperidone AMNEAL | EF | MP NP | C4246 C5907 | | 60 | 5 | 60 | | |
[205] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium)
(a) omit:
| | | a | Rostor 5 | DO | MP NP | | | 30 | 5 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Rostor 5 | DO | MP | | P7598 | 30 | 11 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP | | P7598 | 30 | 11 | 30 | | |
[206] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium)
(a) omit:
| | | a | Rostor 10 | DO | MP NP | | | 30 | 5 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Rostor 10 | DO | MP | | P7598 | 30 | 11 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP | | P7598 | 30 | 11 | 30 | | |
[207] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium)
(a) omit:
| | | a | Rostor 20 | DO | MP NP | | | 30 | 5 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Rostor 20 | DO | MP | | P7598 | 30 | 11 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP | | P7598 | 30 | 11 | 30 | | |
[208] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium)
(a) omit:
| | | a | Rostor 40 | DO | MP NP | | | 30 | 5 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Rostor 40 | DO | MP | | P7598 | 30 | 11 | 30 | | |
| | | a | Rosuvastatin AMNEAL | EF | MP | | P7598 | 30 | 11 | 30 | | |
[209] Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg
(a) omit:
| | | a | Roxithromycin AN | EA | MP NP PDP | | | 10 | 0 | 10 | | |
(b) omit:
| | | a | Roxithromycin-GA | ED | MP NP PDP | | | 10 | 0 | 10 | | |
(c) omit:
| | | a | Roxithromycin AN | EA | MP NP | | P10404 | 20
CN10404 | 0
CN10404 | 10 | | |
(d) omit:
| | | a | Roxithromycin-GA | ED | MP NP | | P10404 | 20
CN10404 | 0
CN10404 | 10 | | |
[210] Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg
(a) omit:
| | | a | Roxithromycin AN | EA | MP NP PDP | | | 5 | 0 | 5 | | |
(b) omit:
| | | a | Roxithromycin-GA | ED | MP NP PDP | | | 5 | 0 | 5 | | |
(c) omit:
| | | a | Roxithromycin AN | EA | MP NP | | P10404 | 10
CN10404 | 0
CN10404 | 5 | | |
(d) omit:
| | | a | Roxithromycin-GA | ED | MP NP | | P10404 | 10
CN10404 | 0
CN10404 | 5 | | |
[211] Schedule 1, Part 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)
omit:
| | | | Ventolin CFC-free | GK | MP NP | | | 2 | 5 | 1 | | |
[212] Schedule 1, Part 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
(a) omit:
| | | | APO-Salbutamol | TX | MP NP | C6815 C6825 | | 2 | 5 | 1 | | |
(b) omit:
| | | | Salbutamol Actavis | EA | MP NP | C6815 C6825 | | 2 | 5 | 1 | | |
| | | | Salbutamol AN | ED | MP NP | C6815 C6825 | | 2 | 5 | 1 | | |
[213] Schedule 1, Part 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
omit:
| | | | Salbutamol Actavis | EA | MP NP | C6815 C6825 | | 2 | 5 | 1 | | |
[214] Schedule 1, Part 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
omit:
| | | a | Auro-Sertraline 50 | DO | MP NP | C4755 C6277 C6289 | | 30 | 5 | 30 | | |
[215] Schedule 1, Part 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
omit:
| | | a | Auro-Sertraline 100 | DO | MP NP | C4755 C6277 C6289 | | 30 | 5 | 30 | | |
[216] Schedule 1, Part 1, entry for Simvastatin in each of the forms: Tablet 10 mg; Tablet 20 mg; Tablet 40 mg; and Tablet 80 mg
(a) omit:
| | | a | Simvastatin AN | EA | MP NP | | | 30 | 5 | 30 | | |
(b) omit:
| | | a | Simvastatin AN | EA | MP | | P7598 | 30 | 11 | 30 | | |
[217] Schedule 1, Part 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
omit:
| | | a | Sumatriptan AN | EA | MP NP | C5259 | | 4 | 5 | 4 | | |
[218] Schedule 1, Part 1, entry for Telmisartan in each of the forms: Tablet 40 mg; and Tablet 80 mg
omit:
| | | a | Telmisartan AN | EA | MP NP | | | 28 | 5 | 28 | | |
[219] Schedule 1, Part 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 40 mg-12.5 mg
omit:
| | | a | Telmisartan HCTZ AN 40/12.5 | EA | MP NP | C4374 | | 28 | 5 | 28 | | |
[220] Schedule 1, Part 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-12.5 mg
omit:
| | | a | Telmisartan HCTZ AN 80/12.5 | EA | MP NP | C4374 | | 28 | 5 | 28 | | |
[221] Schedule 1, Part 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-25 mg
omit:
| | | a | Telmisartan HCTZ AN 80/25 | EA | MP NP | C4374 | | 28 | 5 | 28 | | |
[222] Schedule 1, Part 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
(a) omit:
| | | a | Terbinafine AN | EA | MP NP | C6395 C6404 C6453 | P6404 P6453 | 42 | 0 | 42 | | |
(b) omit:
| | | a | Terbinafine AN | EA | MP NP | C6395 C6404 C6453 | P6395 | 42 | 1 | 42 | | |
[223] Schedule 1, Part 1, entry for Testosterone
omit:
| Capsule containing testosterone undecanoate 40 mg | Oral | | Andriol Testocaps | MK | MP | C6324 C6910 C6919 C6933 C6934 | | 60 | 5 | 60 | | |
[224] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[225] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 1]
(a) insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
(b) insert in numerical order in the column headed “Purposes”: P12404
[226] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[227] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 3]
(a) insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
(b) insert in numerical order in the column headed “Purposes”: P12399 P12405
[228] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[229] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 6]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[230] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 0]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[231] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 1]
(a) insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
(b) insert in numerical order in the column headed “Purposes”: P12404
[232] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 2]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[233] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 3]
(a) insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
(b) insert in numerical order in the column headed “Purposes”: P12399 P12405
[234] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 5]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[235] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 6]
insert in numerical order in the column headed “Circumstances”: C12399 C12404 C12405
[236] Schedule 1, Part 1, entry for Topiramate in each of the forms: Tablet 25 mg; Tablet 50 mg; and Tablet 100 mg
omit:
| | | a | Topiramate AN | EA | MP NP | C5325 C5516 | | 60 | 5 | 60 | | |
[237] Schedule 1, Part 1, entry for Topiramate in the form Tablet 200 mg
omit:
| | | a | Topiramate AN | EA | MP NP | C5516 | | 60 | 5 | 60 | | |
[238] Schedule 1, Part 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg
(a) omit:
| | | a | Tramadol AMNEAL | EF | MP NP | C10764 C10766 C10771 C10772 | P10766 | 10 | 0 | 20 | | |
| | | | | | PDP | C10766 C10768 | P10766 | 10 | 0 | 20 | | |
| | | a | Tramadol AN | EA | MP NP | C10764 C10766 C10771 C10772 | P10766 | 10 | 0 | 20 | | |
| | | | | | PDP | C10766 C10768 | P10766 | 10 | 0 | 20 | | |
(b) omit:
| | | a | Tramadol AMNEAL | EF | MP NP | C10764 C10766 C10771 C10772 | P10764 P10771 P10772 | 20 | 0 | 20 | | |
| | | | | | PDP | C10766 C10768 | P10768 | 20 | 0 | 20 | | |
| | | a | Tramadol AN | EA | MP NP | C10764 C10766 C10771 C10772 | P10764 P10771 P10772 | 20 | 0 | 20 | | |
| | | | | | PDP | C10766 C10768 | P10768 | 20 | 0 | 20 | | |
[239] Schedule 1, Part 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit:
| | | a | Tramadol AN SR | EA | MP NP | C10748 C10752 C10755 | | 20 | 0 | 20 | | |
[240] Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride)
(a) omit:
| | | a | Valaciclovir AN | EA | MP NP | C5940 C5960 C5961 C5962 C5968 | P5960 | 20 | 0 | 10 | | |
(b) omit:
| | | a | Valaciclovir AN | EA | MP NP | C5940 C5960 C5961 C5962 C5968 | P5940 P5961 | 30 | 5 | 30 | | |
(c) omit:
| | | a | Valaciclovir AN | EA | MP NP | C5940 C5960 C5961 C5962 C5968 | P5962 P5968 | 42 | 0 | 42 | | |
[241] Schedule 1, Part 1, entry for Venetoclax in the form Tablet 50 mg
substitute:
| Tablet 50 mg | Oral | | Venclexta | VE | MP | C10995 C12462 | P10995 | 7 | 0 | 7 | | |
| | | | | | MP | C10995 C12462 | P12462 | 28 | 2 | 7 | | |
[242] Schedule 1, Part 1, entry for Venetoclax in the form Tablet 100 mg
substitute:
| Tablet 100 mg | Oral | | Venclexta | VE | MP | C11017 C11069 C11073 C12462 | P12462 | 120 | 2 | 120 | | |
| | | | | | MP | C11017 C11069 C11073 C12462 | P11017 | 120 | 4 | 120 | | |
| | | | | | MP | C11017 C11069 C11073 C12462 | P11069 P11073 | 120 | 5 | 120 | | |
[243] Schedule 1, Part 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)
omit:
| | | a | Venlafaxine AN SR | EA | MP NP | C5650 | | 28 | 0 | 28 | | |
[244] Schedule 1, Part 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
omit:
| | | a | Venlafaxine AN SR | EA | MP NP | C5650 | | 28 | 5 | 28 | | |
[245] Schedule 1, Part 2
insert as first entry:
Benralizumab | Injection 30 mg in 1 mL single dose pre‑filled syringe | Injection | | Fasenra | AP | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | | D(100) |
[246] Schedule 1, Part 2, omit entry for Dalteparin
[247] Schedule 1, Part 2, after entry for Calcipotriol with betamethasone
insert:
Desmopressin | Intranasal solution containing desmopressin acetate
100 micrograms per mL, 2.5 mL dropper bottle | Nasal | | Minirin | FP | MP | C5266 | | 5 | 5 | 1 | | |
[248] Schedule 1, Part 2, omit entry for Mesalazine
[249] Schedule 1, Part 2, after entry for Terbutaline
insert:
Testosterone | Capsule containing testosterone undecanoate 40 mg | Oral | | Andriol Testocaps | MK | MP | C6324 C6910 C6919 C6933 C6934 | | 60 | 5 | 60 | | |
[250] Schedule 3
omit:
DO | Fair-Med Healthcare (Australia) Pty Ltd | 45 118 452 369 |
[251] Schedule 3, after details relevant to Responsible Person code FP
insert:
FQ | Pharmaco (Australia) Limited | 89 113 383 501 |
[252] Schedule 3
omit:
ZA | AstraZeneca Pty Ltd | 54 009 682 311 |
[253] Schedule 4, Part 1, omit entry for Dalteparin
[254] Schedule 4, Part 1, entry for Etanercept
(a) omit:
| C12288 | P12288 | | Severe chronic plaque psoriasis
Initial 3 - Re-treatment (Whole body) within 12 months
Must be treated by a dermatologist.
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND
Patient must have received prior PBS-subsidised treatment with etanercept for this condition in the past 12 months; AND
Patient must have demonstrated a response to etanercept and experienced a disease flare; OR
Patient must not have failed more than once to achieve an adequate response with etanercept; AND
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction.
Patient must be under 18 years of age.
A patient is eligible for re-treatment due to disease flare if there is a 50% or greater change in the patients PASI score or the patient has a current PASI score of greater than 15, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Written Authority Required procedures |
(b) omit:
| C12320 | P12320 | | Severe chronic plaque psoriasis
Initial 3 - Re-treatment (face, hand, foot) within 12 months
Must be treated by a dermatologist.
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received prior PBS-subsidised treatment with etanercept for this condition in the past 12 months; AND
Patient must have demonstrated a response to etanercept and experienced a disease flare; OR
Patient must not have failed more than once to achieve an adequate response with etanercept; AND
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction.
Patient must be under 18 years of age.
A patient is eligible for re-treatment due to disease flare if:
(i) all subscores are rated moderate to severe or 2 of the 3 subscores are rated severe to very severe; or
(ii) the skin area affected is a 50% or greater change or the area affected is 30% or more of the face, palm of a hand or sole of a foot, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Written Authority Required procedures |
(c) insert in numerical order after existing text:
| C12434 | P12434 | | Severe chronic plaque psoriasis
Initial 4 - Re-treatment (face, hand, foot)
Must be treated by a dermatologist.
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot.
Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) all PASI sub-measures (redness, thickness, scaling) are rated as 'moderate' to 'severe', (ii) at least 2 of the 3 PASI sub-measures are rated as 'severe' to 'very severe', (iii) the skin area affected has increased by at least 50% since the last administered dose, (iv) the skin area affected is at least 30% of the total skin area of the face/hand/foot.
Patient must not have failed more than once to achieve an adequate response with etanercept; AND
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Written Authority Required procedures |
| C12457 | P12457 | | Severe chronic plaque psoriasis
Initial 4 - Re-treatment (Whole body)
Must be treated by a dermatologist.
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have a documented history of severe chronic plaque psoriasis of the whole body.
Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following: (i) a disease flare where the PASI score has worsened (increased) by at least 50%, (ii) the current PASI score has returned above 15.
Patient must not have failed more than once to achieve an adequate response with etanercept; AND
Patient must not receive more than 16 weeks of treatment with etanercept under this restriction.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Written Authority Required procedures |
[255] Schedule 4, Part 1, entry for Golimumab
(a) omit:
| C12354 | P12354 | | Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) 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
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/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).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C12366 | P12366 | | Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) 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
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/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).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. | Compliance with Written Authority Required procedures |
(b) insert in numerical order after existing text:
| C12401 | P12401 | | Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
The treatment must be in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient has received 12 weeks or more of therapy with tocilizumab as their most recent treatment, evidence of a response must be provided.
If a patient has not received a minimum of 12 weeks therapy with tocilizumab, evidence of a response is not required to be provided under this restriction. This switch in therapy from tocilizumab will not be counted as treatment failure to tocilizumab.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) 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
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/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).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C12468 | P12468 | | Severe active rheumatoid arthritis
First continuing treatment - Critical shortage of tocilizumab - Temporary listing
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under Initial treatment - Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab); AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) 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
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/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).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence of a response to this drug is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. | Compliance with Written Authority Required procedures |
[256] Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
insert in numerical order after existing text:
| C12459 | | | Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency; AND
Patient must have severe intestinal malabsorption of whole protein ketogenic diet formula; AND
Patient must have unsuccessfully trialled at least one of the PBS-listed products with the indication of: 'Ketogenic diet'.
This product must only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist. | Compliance with Authority Required procedures |
[257] Schedule 4, Part 1, after entry for Lamotrigine
insert:
Lanadelumab | C12416 | | | Chronic treatment of hereditary angioedema Types 1 or 2
Initial 3: Grandfather patient (commencing from non-PBS-subsidised treatment with this drug)
Patient must have previously received non-PBS-subsidised treatment with this drug as routine prophylaxis for hereditary angioedema prior to 1 December 2021; AND
Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; OR
Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab; AND
The treatment must not be used in combination with a C1-esterase inhibitor concentrate.
Must be treated by a clinical immunologist or a specialist allergist.
Patient must be aged 12 years or older.
For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate
The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application. | Compliance with Authority Required procedures |
| C12435 | | | Chronic treatment of hereditary angioedema Types 1 or 2
Continuing preventative treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
The treatment must not be PBS-subsidised in combination with a C1-esterase inhibitor concentrate.
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.
Patient must be aged 12 years or older.
Patients who have successfully transitioned to a lower dosing frequency should be reviewed every 6 months to ensure they continue to demonstrate a sustained response
For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes. | Compliance with Authority Required procedures |
| C12464 | | | Chronic treatment of hereditary angioedema Types 1 or 2
Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)
Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; AND
Patient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; AND
The treatment must not be used in combination with a C1-esterase inhibitor concentrate.
Must be treated by a clinical immunologist or a specialist allergist.
Patient must be aged 12 years or older.
For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate
The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application. | Compliance with Authority Required procedures |
| C12467 | | | Chronic treatment of hereditary angioedema Types 1 or 2
Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)
Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab; AND
The treatment must not be used in combination with a C1-esterase inhibitor concentrate.
Must be treated by a clinical immunologist or a specialist allergist.
Patient must be aged 12 years or older. | Compliance with Authority Required procedures |
[258] Schedule 4, Part 1, after entry for Riluzole
insert:
Ripretinib | C12440 | | | Metastatic or unresectable malignant gastrointestinal stromal tumour
Initial treatment
The condition must not be resectable; AND
The treatment must be as monotherapy; AND
The condition must have progressed despite treatment with all drugs PBS-listed specifically for this PBS-indication; OR
The condition must have progressed despite each of: (i) treatment with a drug PBS-listed specifically listed for this PBS-indication, (ii) an intolerance/expected intolerance to all other drugs PBS-listed for this specific PBS-indication; AND
Patient must have a WHO performance status of 2 or less.
Patient must be undergoing PBS-subsidised treatment with this drug for the first time - retreatment/continuing treatment beyond the available repeat prescription is not permitted under this listing; see 'Continuing treatment' Treatment Phase listing to continue PBS-subsidised treatment in a patient without disease progression. | Compliance with Authority Required procedures |
| C12455 | | | Metastatic or unresectable malignant gastrointestinal stromal tumour
Continuing treatment
The condition must not be resectable; AND
Patient must have received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be as monotherapy; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition. | Compliance with Authority Required procedures |
[259] Schedule 4, Part 1, entry for Tocilizumab
insert in numerical order after existing text:
| C12399 | P12399 | | Severe active juvenile idiopathic arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/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).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C12404 | P12404 | | Severe active juvenile idiopathic arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
(a) 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
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/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).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C12405 | P12405 | | Severe active rheumatoid arthritis
Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) 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
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/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).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
[260] Schedule 4, Part 1, entry for Venetoclax
(a) insert in the column headed “Purposes Code” for the circumstance code “C10995”: P10995
(b) insert in numerical order after existing text:
| C12462 | P12462 | | Acute Myeloid Leukaemia
The condition must be previously untreated at the time of initiation with this drug (except for essential treatment with hydroxyurea or leukapheresis); AND
Patient must not be considered eligible for standard intensive remission induction chemotherapy at the time of initiation with this drug; AND
The treatment must be used in combination with azacitidine (refer to Product Information for timing of azacitidine and venetoclax doses); AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
The condition must not be acute promyelocytic leukaemia.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles. | Compliance with Authority Required procedures |
[261] Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-15475]
omit from the column headed “Brand”: Clopidogrel-GA
[262] Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-15475]
omit from the column headed “Brand”: Clopidogrel AN
[263] Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-17110]
omit from the column headed “Brand”: Clopidogrel-GA
[264] Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110]
omit from the column headed “Brand”: Clopidogrel AN
[265] Schedule 5, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [GRP-14639]
omit from the column headed “Brand”: Doxycycline AN
[266] Schedule 5, after entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [GRP-14639]
insert:
| GRP-15555 | Capsule 100 mg (as hyclate) (containing enteric coated pellets) | Oral | Mayne Pharma Doxycycline |
| | Tablet 100 mg (as hyclate) | Oral | APX-Doxycycline
Doxsig
Doxylin 100 |
| | Tablet 100 mg (as monohydrate) | Oral | APO-Doxycycline
Doxycycline Sandoz |
[267] Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as hyclate) [GRP-15635]
omit from the column headed “Brand”: Doxycycline AN
[268] Schedule 5, entry for Esomeprazole in the form Capsule (enteric) 40 mg (as magnesium) [GRP-17061]
omit from the column headed “Brand”: Esomeprazole ACTAVIS
[269] Schedule 5, entry for Esomeprazole in the form Capsule (enteric) 20 mg (as magnesium) [GRP-17188]
omit from the column headed “Brand": Esomeprazole ACTAVIS
[270] Schedule 5, entry for Fentanyl in the form Transdermal patch 12.375 mg [GRP-15510]
omit from the column headed “Brand”: Dutran 75
[271] Schedule 5, entry for Fentanyl in the form Transdermal patch 4.125 mg [GRP-15577]
omit from the column headed “Brand”: Dutran 25
[272] Schedule 5, entry for Fentanyl in the form Transdermal patch 8.25 mg [GRP-15659]
omit from the column headed “Brand”: Dutran 50
[273] Schedule 5, entry for Fentanyl in the form Transdermal patch 16.5 mg [GRP-15747]
omit from the column headed “Brand”: Dutran 100
[274] Schedule 5, entry for Fentanyl in the form Transdermal patch 2.063 mg [GRP-15898]
omit from the column headed “Brand”: Dutran 12
[275] Schedule 5, entry for Imipramine
omit:
| GRP-24222 | Tablet containing imipramine hydrochloride 25 mg | Oral | Tofranil 25 |
| | Tablet containing imipramine hydrochloride 25 mg USP | Oral | Imipramine (Leading) |
[276] Schedule 5, entry for Meloxicam in the form Tablet 15 mg [GRP-15468]
(a) omit from the column headed “Brand”: Meloxiauro 15
(b) omit from the column headed “Brand”: Meloxicam AN
(c) omit from the column headed “Brand”: Meloxicam-GA
[277] Schedule 5, entry for Meloxicam in the form Tablet 7.5 mg [GRP-15658]
(a) omit from the column headed “Brand”: Meloxiauro 7.5
(b) omit from the column headed “Brand”: Meloxicam AN
(c) omit from the column headed “Brand”: Meloxicam-GA
[278] Schedule 5, entry for Olanzapine in the form Tablet 20 mg (orally disintegrating) [GRP-15643]
omit from the column headed “Brand”: Olanzapine AN ODT
[279] Schedule 5, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating) [GRP-15723]
omit from the column headed “Brand”: Olanzapine AN ODT
[280] Schedule 5, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating) [GRP-15797]
omit from the column headed “Brand”: Olanzapine AN ODT
[281] Schedule 5, entry for Olanzapine in the form Tablet 15 mg (orally disintegrating) [GRP-15953]
omit from the column headed “Brand”: Olanzapine AN ODT
[282] Schedule 5, entry for Omeprazole in the form Tablet 20 mg [GRP-14650]
omit from the column headed “Brand”: Omeprazole AN
[283] Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-15402]
omit from the column headed “Brand”: Zilfojim 8 ODT
[284] Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-15983]
omit from the column headed “Brand”: Zilfojim 4 ODT
[285] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]
(a) omit from the column headed “Brand”: Perindopril Actavis 4
(b) omit from the column headed “Brand”: Perindopril AN
[286] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]
(a) omit from the column headed “Brand”: Perindopril Actavis 8
(b) omit from the column headed “Brand”: Perindopril AN
[287] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]
(a) omit from the column headed ““Brand: Perindopril Actavis 2
(b) omit from the column headed ““Brand: Perindopril AN
[288] Schedule 5, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate
1.25 mg [GRP-15765]
(a) omit from the column headed “Brand”: Perindopril Combi Actavis 4/1.25
(b) omit from the column headed “Brand”: Perindopril and Indapamide AN 4/1.25
[289] Schedule 5, entry for Ramipril in the form Tablet 5 mg [GRP-15424]
omit from the column headed “Brand”: Ramipril AN
[290] Schedule 5, entry for Ramipril in each of the forms: Capsule 10 mg; and Tablet 10 mg [GRP-15431]
omit from the column headed “Brand”: Ramipril AN
[291] Schedule 5, entry for Ramipril in the form Tablet 2.5 mg [GRP-15769]
omit from the column headed “Brand”: Ramipril AN
[292] Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21361]
omit from the column headed “Brand”: Salbutamol Actavis
[293] Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21535]
(a) omit from the column headed “Brand”: APO-Salbutamol
(b) omit from the column headed “Brand”: Salbutamol AN
(c) omit from the column headed “Brand”: Salbutamol Actavis
[294] Schedule 5, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) [GRP-24211]
omit from the column headed “Brand”: Ventolin CFC-free
[295] Schedule 5, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [GRP-15928]
omit from the column headed “Brand”: Sumatriptan AN
[296] Schedule 6, entry for Benralizumab
omit:
Benralizumab | Injection 30 mg in 1 mL single dose pre‑filled syringe | Injection |
1 Name of Instrument