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PB 13 of 2021 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 28 Feb 2021
Tabling HistoryDate
Tabled HR15-Mar-2021
Tabled Senate15-Mar-2021
To be repealed 05 Aug 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

PB 13 of 2021

 

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 2)

 

National Health Act 1953

________________________________________________________________________

 

I, THEA CONNOLLY, Assistant Secretary, 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                  24 February                        2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THEA CONNOLLY

Assistant Secretary

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. 2).

(2)          This Instrument may also be cited as PB 13 of 2021.

2          Commencement

This Instrument commences on 1 March 2021.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).


 


Schedule 1           Amendments

[1]             Schedule 1, Part 1, omit entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid

[2]             Schedule 1, Part 1, after entry for Amino acid formula with vitamins and minerals without methionine in the form Sachets containing oral powder 25 g, 30 (HCU express 15)

                           insert:

 

Sachets containing oral powder 29 g, 30 (HCU Lophlex)

Oral

 

HCU Lophlex

SB

MP NP

C6038

 

4

5

1

 

 

[3]             Schedule 1, Part 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Sachets containing oral powder 25 g, 30 (TYR express 15)

                           insert:

 

Sachets containing oral powder 28 g, 30 (TYR Lophlex)

Oral

 

TYR Lophlex

SB

MP NP

C5533

 

4

5

1

 

 

[4]             Schedule 1, Part 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Sachets containing oral powder 25 g, 30 (MSUD express 15)

                           insert:

 

Sachets containing oral powder 28 g, 30 (MSUD Lophlex)

Oral

 

MSUD Lophlex

SB

MP NP

C5571

 

4

5

1

 

 

[5]             Schedule 1, Part 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

                           omit from the column headed “Responsible Person” for the brand “Norvasc”: UJ      substitute: AS 

[6]             Schedule 1, Part 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

                           omit from the column headed “Responsible Person” for the brand “Caduet 5/40”: UJ                 substitute: AS

[7]             Schedule 1, Part 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

                           omit from the column headed “Responsible Person” for the brand “Caduet 5/80”: UJ                 substitute: AS

[8]             Schedule 1, Part 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)

                           omit from the column headed “Responsible Person” for the brand “Caduet 10/10”: UJ               substitute: AS

[9]             Schedule 1, Part 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)

                           omit from the column headed “Responsible Person” for the brand “Caduet 10/20”: UJ               substitute: AS

[10]           Schedule 1, Part 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

                           omit from the column headed “Responsible Person” for the brand “Caduet 10/40”: UJ               substitute: AS

[11]           Schedule 1, Part 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

                           omit from the column headed “Responsible Person” for the brand “Caduet 10/80”: UJ               substitute: AS

[12]           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)

                           omit from the column headed “Responsible Person” for the brand “Lipitor” (all instances): UJ                    substitute: AS

[13]           Schedule 1, Part 1, entry for Captopril

                           omit:

 

Tablet 12.5 mg

Oral

 

Captopril Sandoz

SZ

MP NP

 

 

90

5

90

 

 

[14]           Schedule 1, Part 1, omit entry for Cefalotin

[15]           Schedule 1, Part 1, omit entry for Cimetidine

[16]           Schedule 1, Part 1, after entry for Desmopressin in the form Intranasal solution containing desmopressin acetate 100 micrograms per mL, 2.5 mL dropper bottle

                           insert:

 

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL

Nasal

 

Desmopressin Acetate (Medsurge)

DZ

MP

C5266 C5267 C5342

P5267 P5342

1

5

1

 

 

 

 

 

 

 

 

NP

C5267 C5342

 

1

5

1

 

 

 

 

 

 

 

 

MP

C5266 C5267 C5342

P5266

2

5

1

 

 

[17]           Schedule 1, Part 1, entry for Dulaglutide

                           insert in numerical order in the column headed “Circumstances”: C5469

[18]           Schedule 1, Part 1, after entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

                           insert:

Dupilumab

Injection 200 mg in 1.14 mL single dose pre-filled syringe

Injection

 

Dupixent

SW

MP

C11372 C11374 C11375 C11377 C11378 C11379

 

2

5

2

 

 

 

Injection 300 mg in 2 mL single dose pre-filled syringe

Injection

 

Dupixent

SW

MP

C11372 C11374 C11375 C11377 C11378 C11379

 

2

5

2

 

 

[19]           Schedule 1, Part 1, entry for Efavirenz

                           omit:

 

Oral solution 30 mg per mL,
180 mL

Oral

 

Stocrin

MK

MP NP

C4454 C4512

 

7

5

1

 

D(100)

[20]           Schedule 1, Part 1, entry for Erythromycin

                           omit:

 

Tablet 400 mg (as ethyl succinate)

Oral

 

E-Mycin

AF

PDP

 

 

25

0

25

 

 

 

 

 

 

 

 

MP NP

 

 

25

1

25

 

 

 

 

 

 

 

 

MP

 

P6160

50
CN6160

5
CN6160

25

 

 

[21]           Schedule 1, Part 1, entry for Esomeprazole

                           substitute:

Esomeprazole

Capsule (enteric) 20 mg (as magnesium)

Oral

 

Esomeprazole ACTAVIS

EA

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

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

 

 

 

 

 

 

Esomeprazole ACTAVIS

EA

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

 

 

 

 

 

 

Noxicid Caps

AL

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

 

 

 

 

 

 

Esomeprazole ACTAVIS

EA

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Noxicid Caps

AL

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

Capsule (enteric) 40 mg (as magnesium)

Oral

 

Esomeprazole ACTAVIS

EA

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Noxicid Caps

AL

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole ACTAVIS

EA

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Noxicid Caps

AL

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole ACTAVIS

EA

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Noxicid Caps

AL

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

 

Esomeprazole Apotex

TX

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Esomeprazole GH

GQ

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Esomeprazole GxP

AF

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Esomeprazole Mylan

AL

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Esomeprazole RBX

RA

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Esomeprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Esomeprazole SZ

HX

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Nexazole

RW

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Nexium

AP

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Nexole

RF

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

NOUMED ESOMEPRAZOLE

VO

MP

C8774 C8775 C8776 C8780 C8827 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

30

1

30

 

 

 

 

 

 

Esomeprazole Apotex

TX

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

 

 

 

 

 

 

Esomeprazole GH

GQ

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

 

 

 

 

 

 

Esomeprazole GxP

AF

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

 

 

 

 

 

 

Esomeprazole Mylan

AL

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

 

 

 

 

 

 

Esomeprazole RBX

RA

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

 

 

 

 

 

 

Esomeprazole Sandoz

SZ

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

 

 

 

 

 

 

Esomeprazole SZ

HX

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

 

 

 

 

 

 

Nexazole

RW

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

 

 

 

 

 

 

Nexium

AP

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

 

 

 

 

 

 

Nexole

RF

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

 

 

 

 

 

 

NOUMED ESOMEPRAZOLE

VO

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

 

 

 

 

 

 

Esomeprazole Apotex

TX

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Esomeprazole GH

GQ

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Esomeprazole GxP

AF

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Esomeprazole Mylan

AL

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Esomeprazole RBX

RA

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Esomeprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Esomeprazole SZ

HX

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Nexazole

RW

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Nexium

AP

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

Nexole

RF

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

 

 

 

NOUMED ESOMEPRAZOLE

VO

MP

C8774 C8775 C8776 C8780 C8827 C11310

P11310

60

5

30

 

 

 

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

 

Esomeprazole Apotex

TX

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole GH

GQ

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole GxP

AF

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole Mylan

AL

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole RBX

RA

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole Sandoz

SZ

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole SZ

HX

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Nexazole

RW

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Nexium

AP

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Nexole

RF

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

NOUMED ESOMEPRAZOLE

VO

MP

C8777 C8778 C8902 C11370

P8902

30

1

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8902

30

1

30

 

 

 

 

 

 

Esomeprazole Apotex

TX

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole GH

GQ

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole GxP

AF

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole Mylan

AL

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole RBX

RA

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole Sandoz

SZ

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole SZ

HX

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Nexazole

RW

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Nexium

AP

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Nexole

RF

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

NOUMED ESOMEPRAZOLE

VO

MP

C8777 C8778 C8902 C11370

P8777 P8778

30

5

30

 

 

 

 

 

 

 

 

NP

C8777 C8778 C8902

P8777 P8778

30

5

30

 

 

 

 

 

 

Esomeprazole Apotex

TX

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Esomeprazole GH

GQ

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Esomeprazole GxP

AF

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Esomeprazole Mylan

AL

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Esomeprazole RBX

RA

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Esomeprazole Sandoz

SZ

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Esomeprazole SZ

HX

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Nexazole

RW

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Nexium

AP

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

Nexole

RF

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

 

 

 

 

NOUMED ESOMEPRAZOLE

VO

MP

C8777 C8778 C8902 C11370

P11370

60

5

30

 

 

[22]           Schedule 1, Part 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

                           omit:

 

 

 

 

Auscap Aspen

RW

MP NP

C4755 C6277

 

28

5

28

 

 

[23]           Schedule 1, Part 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

                           omit:

 

 

 

a

Leucovorin Calcium (Hospira Pty Limited)

PF

MP

 

 

10

2

1

 

 

[24]           Schedule 1, Part 1, omit entry for Grazoprevir with elbasvir

[25]           Schedule 1, Part 1, entry for Idarubicin

                           omit:

 

Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL

Injection

 

Zavedos Solution

PF

MP

C6247

 

See Note 3

See Note 3

1

 

D(100)

[26]           Schedule 1, Part 1, entry for IncobotulinumtoxinA

                           omit from the column headed “Circumstances”: C5220

[27]           Schedule 1, Part 1, after entry for Indacaterol with glycopyrronium

                           insert:

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol
125 micrograms (as acetate) with mometasone furoate
62.5 micrograms (for use in Breezhaler)

Inhalation by mouth

 

Atectura Breezhaler

NV

MP NP

C11360

 

30

5

30

 

 

 

Capsule containing powder for oral inhalation indacaterol
125 micrograms (as acetate) with mometasone furoate
127.5 micrograms (for use in Breezhaler)

Inhalation by mouth

 

Atectura Breezhaler

NV

MP NP

C11360

 

30

5

30

 

 

 

Capsule containing powder for oral inhalation indacaterol
125 micrograms (as acetate) with mometasone furoate
260 micrograms (for use in Breezhaler)

Inhalation by mouth

 

Atectura Breezhaler

NV

MP NP

C11360

 

30

5

30

 

 

[28]           Schedule 1, Part 1, entry for Lanreotide

                           omit:

 

Powder for suspension for injection 30 mg (as acetate) with diluent

Injection

 

Somatuline LA

IS

MP

C7042 C9225

 

2

11

1

 

D(100)

[29]           Schedule 1, Part 1, entry for Lansoprazole in the form Capsule 30 mg 

                           substitute:

 

Capsule 30 mg

Oral

 

APO-Lansoprazole

TX

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

Lanzopran

RA

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

NOUMED LANSOPRAZOLE

VO

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

Zopral

AF

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

APO-Lansoprazole

TX

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

Lanzopran

RA

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

NOUMED LANSOPRAZOLE

VO

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

Zopral

AF

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

APO-Lansoprazole

TX

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

 

 

 

 

Lanzopran

RA

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

 

 

 

 

NOUMED LANSOPRAZOLE

VO

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

 

 

 

 

Zopral

AF

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

[30]           Schedule 1, Part 1, entry for Lansoprazole in the form Tablet 30 mg (orally disintegrating) 

                           substitute:

 

Tablet 30 mg (orally disintegrating)

Oral

 

APO-Lansoprazole ODT

TX

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

Lansoprazole ODT GH

GQ

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

Zopral ODT

AF

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

Zoton FasTabs

PF

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

28

1

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

28

1

28

 

 

 

 

 

 

APO-Lansoprazole ODT

TX

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

Lansoprazole ODT GH

GQ

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

Zopral ODT

AF

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

Zoton FasTabs

PF

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

28

5

28

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

28

5

28

 

 

 

 

 

 

APO-Lansoprazole ODT

TX

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

 

 

 

 

Lansoprazole ODT GH

GQ

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

 

 

 

 

Zopral ODT

AF

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

 

 

 

 

Zoton FasTabs

PF

MP

C8774 C8775 C8776 C8780 C11310

P11310

56

5

28

 

 

[31]           Schedule 1, Part 1, entry for Latanoprost

                           omit from the column headed “Responsible Person” for the brand “Xalatan”: UJ      substitute: AS

[32]           Schedule 1, Part 1, entry for Latanoprost with timolol

                           omit from the column headed “Responsible Person” for the brand “Xalacom”: UJ     substitute: AS

[33]           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

Lercanidipine Sandoz

SZ

MP NP

 

 

28

5

28

 

 


 

[34]           Schedule 1, Part 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

Levetiracetam Mylan

AL

MP NP

C11116

 

60

5

60

 

 

[35]           Schedule 1, Part 1, entry for Levodopa with carbidopa and entacapone in each of the forms: Tablet 50 mg-12.5 mg (as monohydrate)-200 mg; Tablet 75 mg-18.75 mg (as monohydrate)-200 mg; Tablet 100 mg-25 mg (as monohydrate)-200 mg; Tablet 125 mg-31.25 mg (as monohydrate)-200 mg; Tablet 150 mg-37.5 mg (as monohydrate)-200 mg; and Tablet 200 mg-50 mg (as monohydrate)-200 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

L.C.E. Sandoz

HX

MP NP

C5212 C5288

 

200

4

100

 

 

[36]           Schedule 1, Part 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg

                           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

a

LURASIDONE SUN

RA

MP NP

C4246

 

30

5

30

 

 

[37]           Schedule 1, Part 1, omit entry for Metformin with glibenclamide

[38]           Schedule 1, Part 1, entry for Omeprazole in the form Capsule 20 mg

                           substitute:

Omeprazole

Capsule 20 mg

Oral

 

APO-Omeprazole

TX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Maxor

AF

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Omeprazole Sandoz

HX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Pemzo

RW

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Pharmacor Omeprazole 20

CR

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Probitor

SZ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

APO-Omeprazole

TX

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

 

 

 

 

 

 

Maxor

AF

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

 

 

 

 

 

 

Omeprazole Sandoz

HX

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

 

 

 

 

 

 

Pemzo

RW

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

 

 

 

 

 

 

Pharmacor Omeprazole 20

CR

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

 

 

 

 

 

 

Probitor

SZ

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

 

 

 

 

 

 

APO-Omeprazole

TX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Maxor

AF

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Omeprazole Sandoz

HX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Pemzo

RW

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Pharmacor Omeprazole 20

CR

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Probitor

SZ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

[39]           Schedule 1, Part 1, entry for Omeprazole in the form Tablet 20 mg

                           substitute:

 

Tablet 20 mg

Oral

 

APO-Omeprazole

TX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

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

 

 

 

 

 

 

Omeprazole generichealth

GQ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Ozmep

ZP

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

APO-Omeprazole

TX

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

 

 

 

 

 

 

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

 

 

 

 

 

 

Omeprazole generichealth

GQ

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

 

 

 

 

 

 

Ozmep

ZP

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

 

 

 

 

 

 

APO-Omeprazole

TX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Omeprazole AN

EA

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Omeprazole generichealth

GQ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Ozmep

ZP

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

[40]           Schedule 1, Part 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium)

                           substitute:

 

Tablet 20 mg (as magnesium)

Oral

 

Acimax Tablets

AL

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Losec Tablets

AP

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Omepral

ZA

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Omeprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

Acimax Tablets

AL

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

 

 

 

 

 

 

Losec Tablets

AP

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

 

 

 

 

 

 

Omepral

ZA

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

 

 

 

 

 

 

Omeprazole Sandoz

SZ

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

 

 

 

 

 

 

Acimax Tablets

AL

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Losec Tablets

AP

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Omepral

ZA

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

 

Omeprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

[41]           Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg

                           omit from the column headed “Brand” (all instances): Oxycodone Aspen                 substitute: Oxycodone Mylan 

[42]           Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg

                           insert:

Ozanimod

Capsule 920 micrograms

Oral

 

Zeposia

CJ

MP

C10162 C10172

 

28

5

28

 

 

 

Pack containing 4 capsules
230 micrograms and 3 capsules 460 micrograms

Oral

 

Zeposia

CJ

MP

C10162 C10172

 

1

0

1

 

 

[43]           Schedule 1, Part 1, entry for Pantoprazole in the form Sachet containing granules 40 mg (as sodium sesquihydrate) 

                           substitute:

Pantoprazole

Sachet containing granules
40 mg (as sodium sesquihydrate)

Oral

 

Somac

NQ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

[44]           Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

                           substitute:

 

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

a

APO-Pantoprazole

TX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

I-Pantoprazole

CR

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

NOUMED PANTOPRAZOLE

VO

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

Ozpan

RA

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

Panthron

ER

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

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

 

 

 

 

 

a

Pantoprazole 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

 

 

 

 

 

a

Pantoprazole APOTEX

TY

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

Pantoprazole generichealth

HQ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

Pantoprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

Salpraz

AF

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

Somac

NQ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

Sozol

RW

MP

C8774 C8775 C8776 C8780 C8866 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

30

1

30

 

 

 

 

 

a

APO-Pantoprazole

TX

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

 

 

 

 

 

a

I-Pantoprazole

CR

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

 

 

 

 

 

a

NOUMED PANTOPRAZOLE

VO

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

 

 

 

 

 

a

Ozpan

RA

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

 

 

 

 

 

a

Panthron

ER

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

 

 

 

 

 

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

 

 

 

 

 

a

Pantoprazole 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

 

 

 

 

 

a

Pantoprazole APOTEX

TY

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

 

 

 

 

 

a

Pantoprazole generichealth

HQ

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

 

 

 

 

 

a

Pantoprazole Sandoz

SZ

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

 

 

 

 

 

a

Salpraz

AF

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

 

 

 

 

 

a

Somac

NQ

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

 

 

 

 

 

a

Sozol

RW

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

 

 

 

 

 

a

APO-Pantoprazole

TX

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

I-Pantoprazole

CR

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

NOUMED PANTOPRAZOLE

VO

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Ozpan

RA

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Panthron

ER

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Pantoprazole Actavis

ED

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Pantoprazole AN

EA

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Pantoprazole APOTEX

TY

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Pantoprazole generichealth

HQ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Pantoprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Salpraz

AF

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Somac

NQ

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

 

 

 

a

Sozol

RW

MP

C8774 C8775 C8776 C8780 C8866 C11310

P11310

60

5

30

 

 

[45]           Schedule 1, Part 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) 

                           substitute:

 

Tablet containing rabeprazole sodium 20 mg (enteric coated)

Oral

a

APO-Rabeprazole

TX

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

a

Parbezol

RW

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

a

Pariet

JC

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

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

 

 

 

 

 

a

Rabeprazole Mylan

AF

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

a

Rabeprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

a

Rabeprazole SUN

RN

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

a

Zabep

AL

MP

C8774 C8775 C8776 C8780 C11310

P8774 P8775

30

1

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8774 P8775

30

1

30

 

 

 

 

 

a

APO-Rabeprazole

TX

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

30

5

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

a

Parbezol

RW

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

30

5

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

a

Pariet

JC

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

30

5

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

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

 

 

 

 

 

a

Rabeprazole Mylan

AF

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

30

5

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

a

Rabeprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

30

5

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

a

Rabeprazole SUN

RN

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

30

5

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

a

Zabep

AL

MP

C8774 C8775 C8776 C8780 C11310

P8776 P8780

30

5

30

 

 

 

 

 

 

 

 

NP

C8774 C8775 C8776 C8780

P8776 P8780

30

5

30

 

 

 

 

 

a

APO-Rabeprazole

TX

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

 

 

 

a

Parbezol

RW

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

 

 

 

a

Pariet

JC

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

 

 

 

a

Rabeprazole AN

EA

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

 

 

 

a

Rabeprazole Mylan

AF

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

 

 

 

a

Rabeprazole Sandoz

SZ

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

 

 

 

a

Rabeprazole SUN

RN

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

 

 

 

a

Zabep

AL

MP

C8774 C8775 C8776 C8780 C11310

P11310

60

5

30

 

 

[46]           Schedule 1, Part 1, omit entry for Sucralfate

[47]           Schedule 1, Part 1, entry for Tamoxifen

                           omit:

 

Tablet 10 mg (as citrate)

Oral

 

Genox 10

AF

MP NP

C6470

 

60

5

60

 

 

[48]           Schedule 1, Part 1, entry for Verapamil

                           omit:

 

Tablet containing verapamil hydrochloride 40 mg

Oral

 

Anpec 40

AF

MP NP

 

 

100

5

100

 

 

[49]           Schedule 1, Part 2, after entry for Aciclovir

                           insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid

Oral liquid 500 mL, 20
(PKU Baby)

Oral

 

PKU Baby

OH

MP NP

C4295

 

2

5

1

 

 

[50]           Schedule 1, Part 2, after entry for Bortezomib in the form Powder for injection 3.5 mg

                           insert:

Captopril

Tablet 12.5 mg

Oral

 

Captopril Sandoz

SZ

MP NP

 

 

90

5

90

 

 

Cefalotin

Powder for injection 1 g
(as sodium)

Injection

 

DBL Cephalothin

PF

PDP

 

 

10

0

10