National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 11) (Cth)

Case

PB 118 of 2021

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 11)

National Health Act 1953

________________________________________________________________________

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated           29 November 2021

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

________________________________________________________________________

  1. Name of Instrument

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 11).

(2)This instrument may also be cited as PB 118 of 2021.

  1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument 1 December 2021 1 December 2021

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

  1. Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

  1. Schedule

Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

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:

a Lovir EA MP NP C5942 90 5 90

  1. 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

  1. Schedule 1, Part 1, entry for Alendronic acid

omit:

a Densate 70 DO MP NP C6310 C6323 C6327 4 5 4

  1. Schedule 1, Part 1, entry for Amisulpride in the form Tablet 100 mg

omit:

a Amisulpride AN EA MP NP C4246 30 5 30

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Azathioprine in the form Tablet 50 mg

omit:

a Azathioprine AN EA MP NP 100 5 100

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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

  1. 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)

  1. 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

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Clarithromycin in the form Tablet 250 mg

omit:

a Clarac ED MP NP 14 1 14

  1. Schedule 1, Part 1, entry for Clomipramine

omit from the column headed “Responsible Person” for the brand “Anafranil 25”: SZ                     substitute: PB

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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)

  1. 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)

  1. 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)

  1. 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)

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Dorzolamide

omit:

a APO-Dorzolamide TX AO MP 1 5 1

  1. 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

  1. Schedule 1, Part 1, entry for Doxycycline in the form Capsule 100 mg (as hyclate) (containing enteric coated pellets)

omit:

Doryx YN MP NP P4485 21 0 21

  1. 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

  1. Schedule 1, Part 1, entry for Doxycycline in the form Tablet 100 mg (as hyclate)

(a)omit:

Doxycycline AN EA PDP 7 0 7

(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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. Schedule 1, Part 1, entry for Fosinopril with hydrochlorothiazide

omit:

a Fosinopril/HCT Actavis 20/12.5 EA MP NP C4389 30 5 30

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Gabapentin in the form Tablet 800 mg

omit:

a Gabapentin AN EA MP NP C4928 100 5 100

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Imipramine

omit:

Tablet containing imipramine hydrochloride 25 mg USP Oral Imipramine (Leading) QY MP NP 50 2 100

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Irbesartan in the form Tablet 75 mg

omit:

a Irbesartan Actavis 75 ED MP NP 30 5 30

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Latanoprost

omit:

a Latanoprost Actavis EA AO MP 1 5 1

  1. 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

  1. 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:

a Lercadip EA MP NP 28 5 28

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 15 mg

omit:

a Mirtazapine AN EA MP NP C5650 30 5 30

  1. 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

  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg

omit:

a Mirtazapine AN EA MP NP C5650 30 5 30

  1. 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

  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg

omit:

a Mirtazapine AN EA MP NP C5650 30 5 30

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Paroxetine

omit:

a Roxet 20 DO MP NP C4755 C6277 C6636 30 5 30

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Ramipril in the form Capsule 10 mg

omit:

Ramipril AN EA MP NP 30 5 30

  1. Schedule 1, Part 1, entry for Ramipril in each of the forms: Tablet 2.5 mg; Tablet 5 mg; and Tablet 10 mg

omit:

Ramipril AN EA MP NP 30 5 30

  1. 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

  1. Schedule 1, Part 1, entry for Ribavirin

insert as first entry:

Tablet 200 mg Oral Ibavyr IX MP NP C5957 200 2 100

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, Part 1, entry for Topiramate in the form Tablet 200 mg

omit:

a Topiramate AN EA MP NP C5516 60 5 60

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. Schedule 1, Part 2, omit entry for Dalteparin

  1. 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

  1. Schedule 1, Part 2, omit entry for Mesalazine

  1. 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

  1. Schedule 3

omit:

DO Fair-Med Healthcare (Australia) Pty Ltd 45 118 452 369

  1. Schedule 3, after details relevant to Responsible Person code FP

insert:

FQ Pharmaco (Australia) Limited 89 113 383 501

  1. Schedule 3

omit:

ZA AstraZeneca Pty Ltd 54 009 682 311

  1. Schedule 4, Part 1, omit entry for Dalteparin

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-15475]

omit from the column headed “Brand”: Clopidogrel-GA

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-15475]

omit from the column headed “Brand”: Clopidogrel AN

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as besilate) [GRP-17110]

omit from the column headed “Brand”: Clopidogrel-GA

  1. Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [GRP-17110]

omit from the column headed “Brand”: Clopidogrel AN

  1. Schedule 5, entry for Doxycycline in the form Tablet 100 mg (as hyclate) [GRP-14639]

omit from the column headed “Brand”: Doxycycline AN

  1. 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

  1. Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as hyclate) [GRP-15635]

omit from the column headed “Brand”: Doxycycline AN

  1. Schedule 5, entry for Esomeprazole in the form Capsule (enteric) 40 mg (as magnesium) [GRP-17061]

omit from the column headed “Brand”: Esomeprazole ACTAVIS

  1. Schedule 5, entry for Esomeprazole in the form Capsule (enteric) 20 mg (as magnesium) [GRP-17188]

omit from the column headed “Brand": Esomeprazole ACTAVIS

  1. Schedule 5, entry for Fentanyl in the form Transdermal patch 12.375 mg [GRP-15510]

omit from the column headed “Brand”: Dutran 75

  1. Schedule 5, entry for Fentanyl in the form Transdermal patch 4.125 mg [GRP-15577]

omit from the column headed “Brand”: Dutran 25

  1. Schedule 5, entry for Fentanyl in the form Transdermal patch 8.25 mg [GRP-15659]

omit from the column headed “Brand”: Dutran 50

  1. Schedule 5, entry for Fentanyl in the form Transdermal patch 16.5 mg [GRP-15747]

omit from the column headed “Brand”: Dutran 100

  1. Schedule 5, entry for Fentanyl in the form Transdermal patch 2.063 mg [GRP-15898]

omit from the column headed “Brand”: Dutran 12

  1. 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)

  1. 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

  1. 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

  1. Schedule 5, entry for Olanzapine in the form Tablet 20 mg (orally disintegrating) [GRP-15643]

omit from the column headed “Brand”: Olanzapine AN ODT

  1. Schedule 5, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating) [GRP-15723] 

omit from the column headed “Brand”: Olanzapine AN ODT

  1. Schedule 5, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating) [GRP-15797]

omit from the column headed “Brand”: Olanzapine AN ODT

  1. Schedule 5, entry for Olanzapine in the form Tablet 15 mg (orally disintegrating) [GRP-15953]

omit from the column headed “Brand”: Olanzapine AN ODT

  1. Schedule 5, entry for Omeprazole in the form Tablet 20 mg [GRP-14650]

omit from the column headed “Brand”: Omeprazole AN

  1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-15402]

omit from the column headed “Brand”: Zilfojim 8 ODT

  1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-15983]

omit from the column headed “Brand”: Zilfojim 4 ODT

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 5, entry for Ramipril in the form Tablet 5 mg [GRP-15424]

omit from the column headed “Brand”: Ramipril AN

  1. 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

  1. Schedule 5, entry for Ramipril in the form Tablet 2.5 mg [GRP-15769]

omit from the column headed “Brand”: Ramipril AN

  1. 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

  1. 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

  1. 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

  1. Schedule 5, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [GRP-15928]

omit from the column headed “Brand”: Sumatriptan AN

  1. Schedule 6, entry for Benralizumab

omit:

Benralizumab Injection 30 mg in 1 mL single dose pre‑filled syringe Injection
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0