National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 2) (PB 13 of 2021) (Cth)

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

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.

Commencement

This Instrument commences on 1 March 2021.

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

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

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

MP NP

C6038

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

MP NP

C5533

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

MP NP

C5571

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

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

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

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

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

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

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

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

Schedule 1, Part 1, entry for Captopril

omit:

Tablet 12.5 mg

Oral

Captopril Sandoz

MP NP

Schedule 1, Part 1, omit entry for Cefalotin

Schedule 1, Part 1, omit entry for Cimetidine

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

Schedule 1, Part 1, entry for Dulaglutide

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

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

Schedule 1, Part 1, entry for Efavirenz

omit:

Oral solution 30 mg per mL,
180 mL

Oral

Stocrin

MP NP

C4454 C4512

D(100)

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

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

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

omit:

Auscap Aspen

MP NP

C4755 C6277

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:

Leucovorin Calcium (Hospira Pty Limited)

Schedule 1, Part 1, omit entry for Grazoprevir with elbasvir

Schedule 1, Part 1, entry for Idarubicin

omit:

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

Injection

Zavedos Solution

C6247

See Note 3

D(100)

Schedule 1, Part 1, entry for IncobotulinumtoxinA

omit from the column headed “Circumstances”: C5220

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

Schedule 1, Part 1, entry for Lanreotide

omit:

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

Injection

Somatuline LA

C7042 C9225

D(100)

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

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

Schedule 1, Part 1, entry for Latanoprost

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

Schedule 1, Part 1, entry for Latanoprost with timolol

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

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:

Lercanidipine Sandoz

MP NP

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”:

Levetiracetam Mylan

MP NP

C11116

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”:

L.C.E. Sandoz

MP NP

C5212 C5288

200

100

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”:

LURASIDONE SUN

MP NP

C4246

Schedule 1, Part 1, omit entry for Metformin with glibenclamide

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

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

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

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

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

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

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

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

Schedule 1, Part 1, omit entry for Sucralfate

Schedule 1, Part 1, entry for Tamoxifen

omit:

Tablet 10 mg (as citrate)

Oral

Genox 10

MP NP

C6470

Schedule 1, Part 1, entry for Verapamil

omit:

Tablet containing verapamil hydrochloride 40 mg

Oral

Anpec 40

MP NP

100

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

MP NP

C4295

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
MP NP	10	1	10
Cimetidine	Tablet 400 mg	Oral	Magicul 400	AF	MP NP	60	5	60

Schedule 1, Part 2, omit entry for Cefazolin

Schedule 1, Part 2, after entry for Donepezil

insert:

Efavirenz

Oral solution 30 mg per mL,
180 mL

Oral

Stocrin

MP NP

C4454 C4512

D(100)

Schedule 1, Part 2, after entry for Enoxaparin in the form Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe

insert:

Erythromycin	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

Schedule 1, Part 2, entry for Folinic acid

substitute:

Folinic acid

Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

Injection

Leucovorin Calcium (Hospira Pty Limited)

Schedule 1, Part 2, after entry for Folinic acid

insert:

Grazoprevir with elbasvir	Tablet containing grazoprevir 100 mg with elbasvir 50 mg	Oral	Zepatier	MK	MP NP	C5969 C6625	P5969	28	2	28
MP NP	C5969 C6625	P6625	28	3	28

Schedule 1, Part 2, after entry for Labetalol

insert:

Lanreotide

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

Injection

Somatuline LA

C7042 C9225

D(100)

Schedule 1, Part 2, after entry for Metformin

insert:

Metformin with glibenclamide	Tablet containing metformin hydrochloride 250 mg with glibenclamide 1.25 mg	Oral	Glucovance 250mg/1.25mg	AL	MP NP	90	5	90
Tablet containing metformin hydrochloride 500 mg with glibenclamide 2.5 mg	Oral	Glucovance 500mg/2.5mg	AL	MP NP	90	5	90
Tablet containing metformin hydrochloride 500 mg with glibenclamide 5 mg	Oral	Glucovance 500mg/5mg	AL	MP NP	90	5	90

Schedule 1, Part 2, after entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

insert:

Sucralfate	Tablet equivalent to 1 g anhydrous sucralfate	Oral	Carafate	AF	MP NP	120	2	120
Tamoxifen	Tablet 10 mg (as citrate)	Oral	Genox 10	AF	MP NP	C6470	60	5	60

Schedule 1, Part 2, after entry for Venlafaxine in the form Capsule (modified release) 150 mg (as hydrochloride)

insert:

Verapamil

Tablet containing verapamil hydrochloride 40 mg

Oral

Anpec 40

MP NP

100

Schedule 4, Part 1, entry for Ciclosporin

(a)omit entry for Purposes Code “P6660” and substitute:

P6660

CN6660

Severe atopic dermatitis
Management (initiation, stabilisation and review of therapy)
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies.

Compliance with Authority Required procedures - Streamlined Authority Code 6660

(b)omit entry for Purposes Code “P9695” and substitute:

P9695

CN9695

Compliance with Authority Required procedures - Streamlined Authority Code 9695

Schedule 4, Part 1, entry for Dulaglutide

insert as first entry:

C5469

Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
The treatment must be in combination with metformin unless contraindicated or not tolerated; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 5469

Schedule 4, Part 1, after entry for Duloxetine

insert:

Dupilumab	C11372	Chronic severe atopic dermatitis Initial treatment of the face and/or hands The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days; OR The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days; AND Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days; AND The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND Patient must not have experienced an inadequate response to this biological medicine in this PBS indication. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. Patient must be 12 years of age or older. State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings for erythema, oedema/papulation, excoriation, lichenification, in the authority application. These 4 symptom sub-score ratings must have been assessed within the past 4 weeks. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine is/are to be documented in the patient's medical records.	Compliance with Authority Required procedures
C11374	Chronic severe atopic dermatitis Continuing or resuming treatment of the whole body Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the whole body; AND Patient must have achieved an adequate response within the first 16 weeks of treatment; OR Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; OR Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND The treatment must be the sole PBS-subsidised biological medicine for this PBS indication. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. For the purposes of this restriction, an adequate response to treatment is defined as: (a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and (b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above. State each of the current EASI and DLQI scores for this authority application.	Compliance with Authority Required procedures
C11375	Chronic severe atopic dermatitis Initial treatment of the whole body Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days; AND Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical corticosteroids of medium to high potency for at least 28 days; AND Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days; AND The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND Patient must not have experienced an inadequate response to this biological medicine in this PBS indication. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. Patient must be 12 years of age or older. State each of the qualifying PGA, EASI and DLQI scores in the authority application. These baseline scores must have been measured within the past 4 weeks. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine is/are to be documented in the patient's medical records. The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction.	Compliance with Authority Required procedures
C11377	Chronic severe atopic dermatitis Continuing or resuming treatment of the face and/or hands Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND Patient must have achieved an adequate response within the first 16 weeks of treatment; OR Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; OR Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND The treatment must be the sole PBS-subsidised biological medicine for this PBS indication. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as: (a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or (ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and (b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above. Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes	Compliance with Authority Required procedures
C11378	Chronic severe atopic dermatitis Transitioning from non-PBS to PBS-subsidised supply - treatment of the whole body (Grandfather listing) Patient must have been receiving treatment with this biological medicine for this PBS indication prior to 1 March 2021; AND Patient must have had a Physicians Global Assessment (PGA) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days prior to commencing non-PBS-subsidised therapy with this biological medicine; AND Patient must have had an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days prior to commencing non-PBS-subsidised therapy with this biological medicine; AND Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days, prior to having commenced non-PBS-subsidised therapy with this biological medicine; OR Patient must have, where the above baseline DLQI was not recorded in the patient's medical records, a current age-appropriate DLQI score (of any value) measured; AND The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands, prior to commencing non-PBS-subsidised therapy with this biological medicine; AND Patient must not be experiencing an inadequate response to current non-PBS-subsidised therapy with this biological medicine; AND The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND Patient must not have experienced an inadequate response to this biological medicine in this indication, prior to commencing non-PBS-subsidised therapy with this biological medicine. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. Patient must be 12 years of age or older. State each of the qualifying PGA, EASI and DLQI scores in the authority application. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine must be documented in the patient's medical records. The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
C11379	Chronic severe atopic dermatitis Transitioning from non-PBS to PBS-subsidised supply - treatment of the face and/or hands (Grandfather listing) Patient must have been receiving treatment with this biological medicine for this PBS indication prior to 1 March 2021; AND The condition must have had at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days, prior to commencing non-PBS-subsidised therapy with this biological medicine; OR The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days corticosteroid therapy, prior to commencing non-PBS-subsidised therapy with this biological medicine; AND Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical corticosteroid therapy of medium to high potency for at least 28 days, prior to having commenced non-PBS-subsidised therapy with this biological medicine; OR Patient must have, where the above baseline DLQI was not recorded in the patient's medical records, a current age-appropriate DLQI score (of any value) measured; AND The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands, prior to commencing non-PBS-subsidised therapy with this biological medicine; AND Patient must not be experiencing an inadequate response to current non-PBS-subsidised therapy with this biological medicine; AND The treatment must be the sole PBS-subsidised biological medicine for this condition; AND Patient must not have experienced an inadequate response to this biological medicine in this indication, prior to commencing non-PBS-subsidised therapy with this biological medicine. Must be treated by a dermatologist; OR Must be treated by a clinical immunologist. Patient must be 12 years of age or older. State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings for erythema, oedema/papulation, excoriation, lichenification that were present prior to having commenced non-PBS-subsidised therapy, in the authority application. The name/s of the medium to high potency topical corticosteroids trialled prior to commencing treatment with this biological medicine is/are to be documented in the patient's medical records. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Esomeprazole

insert in numerical order after existing text:

C11310	P11310	Complex gastro-oesophageal reflux disease (GORD) One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control Must be treated by a gastroenterologist; OR Must be treated by a surgeon with expertise in the upper gastrointestinal tract; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist's name documented in the patient's medical records for auditing purposes; OR Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist's name documented in the patient's medical records for auditing purposes. The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing. Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.	Compliance with Authority Required procedures
C11370	P11370	Complex gastro-oesophageal reflux disease (GORD) One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control Must be treated by a gastroenterologist; OR Must be treated by a surgeon with expertise in the upper gastrointestinal tract. The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND Patient must have symptoms inadequately controlled with each of: (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing. Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.	Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Etanercept

omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code “C8842”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for IncobotulinumtoxinA

omit:

C5220

Moderate to severe spasticity of the upper limb following a stroke
The condition must be moderate to severe spasticity of the upper limb/s following stroke, defined as a Modified Ashworth Scale rating of 3 or more; AND
The treatment must not be initiated until three months post-stroke; AND
The treatment must only be used as second line therapy when standard management has failed; OR
The treatment must only be used as an adjunct to physical therapy; AND
The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating greater than 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (total Botox, Dysport, and Xeomin); AND
The treatment must not exceed 4 treatment periods (total Botox, Dysport, and Xeomin) per upper limb per lifetime; AND
Patient must not have established severe contracture in the limb to be treated.
Patient must be aged 18 years or older.
Must be treated by a neurologist; OR
Must be treated by an orthopaedic surgeon; OR
Must be treated by a rehabilitation specialist; OR
Must be treated by a plastic surgeon; OR
Must be treated by a geriatrician.
The date of the stroke must be documented in the patient's medical records when treatment is initiated.
Standard management includes physiotherapy and/or oral spasticity agents.

Compliance with Authority Required procedures - Streamlined Authority Code 5220

Schedule 4, Part 1, after entry for Indacaterol with glycopyrronium

insert:

Indacaterol with mometasone

C11360

Asthma
Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 11360

Schedule 4, Part 1, entry for Lansoprazole

insert in numerical order after existing text:

C11310

P11310

Complex gastro-oesophageal reflux disease (GORD)
One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control
Must be treated by a gastroenterologist; OR
Must be treated by a surgeon with expertise in the upper gastrointestinal tract; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist's name documented in the patient's medical records for auditing purposes; OR
Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist's name documented in the patient's medical records for auditing purposes.
The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND
Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR
Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR
Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR
Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.
Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Omeprazole

insert in numerical order after existing text:

C11310

P11310

Compliance with Authority Required procedures

Schedule 4, Part 1, after entry for Oxycodone with naloxone

insert:

Ozanimod	C10162	Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 10162
C10172	Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 10172

Schedule 4, Part 1, entry for Pantoprazole

insert in numerical order after existing text:

C11310

P11310

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Rabeprazole

insert in numerical order after existing text:

C11310

P11310

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Selexipag

(a)omit entry for Circumstances Code “C11195” and substitute:

C11195

P11195

Pulmonary arterial hypertension (PAH)
Initial treatment following dose titration
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
Patient must have completed the dose titration phase; AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

Compliance with Authority Required procedures

(b)omit entry for Circumstances Code “C11241” and substitute:

C11241

P11241

Pulmonary arterial hypertension (PAH)
Transitioning from non-PBS subsidised to PBS-subsidised supply - 'Grandfather' treatment
Patient must have received non-PBS subsidised treatment with this drug prior to 1 February 2021; AND
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy, prior to treatment initiation with this drug; AND
Patient must have had WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have had WHO Functional Class IV PAH at treatment initiation with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
(i) Hospitalisation due to worsening PAH;
(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;
(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;
(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

Compliance with Authority Required procedures

(c)omit entry for Circumstances Code “C11261” and substitute:

C11261

P11261

Pulmonary arterial hypertension (PAH)
Initial treatment - dose titration
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

Compliance with Authority Required procedures

Schedule 4, Part 3 - General statement for drugs for the treatment of hepatitis C

substitute:

Part 3—General statement for drugs for the treatment of hepatitis C

1 Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(1)the patient has been assessed in accordance with paragraph 2 of this Part; and

(2) the patient is:

(a) treated by a medical practitioner or an authorised nurse practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or

(b) treated by a medical practitioner or an authorised nurse practitioner in consultation with:

(i) a gastroenterologist; or

(ii) a hepatologist; or

(iii) an infectious diseases physician.

2 Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

(1)documented the following information in the patient’s medical records:

(a)evidence of chronic hepatitis C infection; and

(b)where possible, evidence of the patient’s hepatitis C virus genotype; and

(2)chosen a regimen in accordance with paragraph 3 of this Part; and

(3)collected the following information for the purposes of the authority application:

(a)whether the patient is:

(i)cirrhotic; or

(ii)non-cirrhotic

(b)details of the previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir or glecaprevir with pibrentasvir for treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).

(4)In this paragraph, evidence of chronic hepatitis C infection is documentation of:

(a)repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

(b)test result showing hepatitis C virus ribonucleic acid (RNA) positive.

3 Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

(1)is a kind of patient mentioned for an Item in column 2 of the following table; and

(2)is to receive one of the regimens mentioned in column 3 of the same Item of the following table.

Item	Kind of patient	Regimen
1	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) GLECAPREVIR with PIBRENTASVIR for 8 weeks.
2	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 8 weeks; or (d) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (e) GLECAPREVIR with PIBRENTASVIR 16 weeks.
3	Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Either: (a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or (b) LEDIPASVIR with SOFOSBUVIR for 12 weeks
4	Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	LEDIPASVIR with SOFOSBUVIR for 12 weeks
5	Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
6	Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
7	Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
8	Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
9	Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
10	Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
11	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
12	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
13	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment naïve; and (c) who is cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) GLECAPREVIR with PIBRENTASVIR for 12 weeks.
14	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment experienced; and (c) who is cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (d) GLECAPREVIR with PIBRENTASVIR 16 weeks.
15	Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is cirrhotic.	LEDIPASVIR with SOFOSBUVIR for 12 weeks
16	Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is cirrhotic.	LEDIPASVIR with SOFOSBUVIR for 24 weeks
17	Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
18	Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
19	Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
20	Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
21	Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
22	Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
23	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
24	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).

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

insert:

Desmopressin	GRP-24629	Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL	Nasal	Desmopressin Acetate (Medsurge)
Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL	Nasal	Minirin Nasal Spray

Schedule 5, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride) [GRP-24550]

omit from the column headed “Brand”: Auscap Aspen