National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 9) (Cth)

PB 97 of 2021

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 9)

National Health Act 1953

________________________________________________________________________

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

Dated           28 September 2021

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

________________________________________________________________________

1. Name of Instrument

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 9).

(2)This instrument may also be cited as PB 97 of 2021.

1. Commencement

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

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

Note:    This table relates only to the provisions of this instrument as originally made.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

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

1. Authority

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

1. Schedule

Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1 - Amendments

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

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen

substitute:

Injection 40 mg in 0.4 mL pre-filled pen	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P11713	2	0	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147	2	2	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199	2	3	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P11107 P12103 P12105 P12153 P12155 P12161 P12212	2	4	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P12273	4	2	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P12273	4	2	4
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P12272 P12315	4	5	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P12272 P12315	4	5	4
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336	6	0	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336	P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336	6	0	6

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen

substitute:

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

AN

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

C(100)

Hadlima

RF

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

C(100)

Hyrimoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

C(100)

Idacio

PK

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

C(100)

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11713

2

0

2

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11713

2

0

2

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11713

2

0

2

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11713

2

0

2

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

MP

C11526 C12116

2

5

2

C(100)

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

MP

C11526 C12116

2

5

2

C(100)

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

MP

C11526 C12116

2

5

2

C(100)

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240

2

5

2

MP

C11526 C12116

2

5

2

C(100)

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P12273

4

2

2

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P12273

4

2

2

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P12273

4

2

2

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P12273

4

2

2

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11529 P12272 P12315

4

5

2

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11529 P12272 P12315

4

5

2

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11529 P12272 P12315

4

5

2

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P11529 P12272 P12315

4

5

2

Amgevita

AN

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

(c)omit from the column headed “Purposes”: P6946            substitute: P12273

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

(c)omit from the column headed “Purposes”: P10838          substitute: P12306

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 3; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

(c)omit from the column headed “Purposes”: P6963 P10892

(d)insert in numerical order in the column headed “Purposes”: P12275 P12278

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

(c)omit from the column headed “Purposes”: P6946            substitute: P12273

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

(c)omit from the column headed “Purposes”: P10838          substitute: P12306

1. Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 3; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C6946 C6963 C10838 C10892

(b)insert in numerical order in the column headed “Circumstances”: C12273 C12275 C12278 C12306

(c)omit from the column headed “Purposes”: P6963 P10892

(d)insert in numerical order in the column headed “Purposes”: P12275 P12278

1. Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL

omit from the column headed “Circumstances”: C10204

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

insert:

Brolucizumab Solution for intravitreal injection 19.8 mg in 0.165 mL pre-filled syringe Injection Beovu NV MP C12268 C12312 C12335 1 2 1

1. Schedule 1, Part 1, after entry for Ciclosporin in the form Capsule 100 mg

insert:

Eye drops 1 mg per mL, single dose units 0.3 mL, 30 Application to the eye Ikervis CS MP AO C12284 C12346 1 5 1

1. Schedule 1, Part 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C10131

(b)omit from the column headed “Purposes”: P10131

1. Schedule 1, Part 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]

omit from the column headed “Circumstances”: C10131

1. Schedule 1, Part 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C10131

(b)omit from the column headed “Purposes”: P10131

1. Schedule 1, Part 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 5]

omit from the column headed “Circumstances”: C10131

1. Schedule 1, Part 1, entry for Darunavir

insert as first entry:

Tablet 600 mg Oral Darunavir Juno JU MP NP C5094 120 5 60 D(100)

1. Schedule 1, Part 1, after entry for Darunavir in the form Tablet 600 mg (as ethanolate)

insert:

Tablet 800 mg Oral Darunavir Juno JU MP NP C4313 60 5 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]

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

a Deferasirox ARX XT MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7385 P8326 P8328 P8329 P9222 P9258 P9302 180 2 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]

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

a Deferasirox ARX XT MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7374 P7375 180 5 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]

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

a Deferasirox ARX XT MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7385 P8326 P8328 P8329 P9222 P9258 P9302 180 2 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]

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

a Deferasirox ARX XT MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7374 P7375 180 5 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]

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

a Deferasirox ARX XT MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7385 P8326 P8328 P8329 P9222 P9258 P9302 180 2 30 D(100)

1. Schedule 1, Part 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]

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

a Deferasirox ARX XT MP C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302 P7374 P7375 180 5 30 D(100)

1. Schedule 1, Part 1, entry for Durvalumab in each of the forms: Solution concentrate for I.V. infusion 120 mg in 2.4 mL; and Solution concentrate for I.V. infusion 500 mg in 10 mL

(a)omit from the column headed “Circumstances”: C10145 C10174

(b)insert in numerical order in the column headed “Circumstances”: C12271

1. Schedule 1, Part 1, omit entry for Enfuvirtide

1. Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate) 

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

a APX-Escitalopram TY MP NP C4755 28 5 28

1. Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
   1 mL [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6843

(b)insert in numerical order in the column headed “Circumstances”: C12260 C12261 C12262 C12265 C12266 C12287 C12288 C12289 C12320 C12327

(c)omit from the column headed “Purposes”: P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6843

(d)insert in numerical order in the column headed “Purposes”: P12260 P12261 P12262 P12265 P12266 P12287 P12288 P12289 P12320 P12327

1. Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
   1 mL [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6843

(b)insert in numerical order in the column headed “Circumstances”: C12260 C12261 C12262 C12265 C12266 C12287 C12288 C12289 C12320 C12327

1. Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6843

(b)insert in numerical order in the column headed “Circumstances”: C12260 C12261 C12262 C12265 C12266 C12287 C12288 C12289 C12320 C12327

(c)omit from the column headed “Purposes”: P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6843

(d)insert in numerical order in the column headed “Purposes”: P12260 P12261 P12262 P12265 P12266 P12287 P12288 P12289 P12320 P12327

1. Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6843

(b)insert in numerical order in the column headed “Circumstances”: C12260 C12261 C12262 C12265 C12266 C12287 C12288 C12289 C12320 C12327

1. Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum
   Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6843

(b)insert in numerical order in the column headed “Circumstances”: C12260 C12261 C12262 C12265 C12266 C12287 C12288 C12289 C12320 C12327

(c)omit from the column headed “Purposes”: P6811 P6814 P6818 P6819 P6822 P6823 P6830 P6843

(d)insert in numerical order in the column headed “Purposes”: P12260 P12261 P12262 P12265 P12266 P12287 P12288 P12289 P12320 P12327

1. Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum
   Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6811 C6814 C6818 C6819 C6822 C6823 C6830 C6843

(b)insert in numerical order in the column headed “Circumstances”: C12260 C12261 C12262 C12265 C12266 C12287 C12288 C12289 C12320 C12327

1. Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

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

a FLUTICASONE SALMETEROL CIPHALER 250/50 LR MP NP C4930 1 5 1

1. Schedule 1, Part 1, entry for Furosemide in the form Tablet 40 mg

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

a NOUMED FUROSEMIDE VO MP NP 100 1 100

1. Schedule 1, Part 1, entry for Ganciclovir

omit from the column headed “Responsible Person”: HN             substitute: XC

1. Schedule 1, Part 1, entry for Hyoscine

omit from the column headed “Responsible Person”: XC              substitute: XN

1. Schedule 1, Part 1, entry for Lincomycin

omit from the column headed “Responsible Person”: XC             substitute: XN

1. Schedule 1, Part 1, entry for Mannitol

(a)omit from the column headed “Brand”: bronchitol        substitute: Bronchitol

(b)omit from the column headed “Responsible Person”: XA              substitute: HT

1. Schedule 1, Part 1, entry for Methyldopa

omit from the column headed “Schedule Equivalent”: a

1. Schedule 1, Part 1, entry for Naloxone in the form Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

omit from the column headed “Responsible Person”: XC              substitute: XN

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

omit from the column headed “Schedule Equivalent”: a

1. Schedule 1, Part 1, omit entry for Nedocromil

1. Schedule 1, Part 1, entry for Nicotine in the form Transdermal patch 114 mg

omit from the column headed “Responsible Person”: GC              substitute: GJ

1. Schedule 1, Part 1, omit entry for Nilutamide

1. Schedule 1, Part 1, entry for Nitrofurantoin in the form Capsule 50 mg

omit from the column headed “Schedule Equivalent” (all instances): a

1. Schedule 1, Part 1, after entry for Nitrofurantoin in the form Capsule 50 mg

insert:

Capsule 50 mg, USP Oral Nitrofurantoin Capsules, USP, (Macrocrystals) DZ MP NP MW 30 1 100

1. Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)omit from the column headed “Circumstances”: C10118

(b)omit from the column headed “Circumstances”: C10156

1. Schedule 1, Part 1, after entry for Octreotide in the form Injection (modified release) 30 mg (as acetate), vial and diluent syringe

insert:

Ofatumumab	Solution for injection 20 mg in 0.4 mL pre-filled pen	Injection	Kesimpta	NV	MP	C10162 C10172 C12224	P10172 P12224	1	5	1
MP	C10162 C10172 C12224	P10162	3	0	1

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

omit from the column headed “Schedule Equivalent”: a

1. Schedule 1, Part 1, entry for Paracetamol in the form Suppository 500 mg

omit from the column headed “Responsible Person”: GC             substitute: GJ

1. Schedule 1, Part 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 3]

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

a CHEMISTS' OWN OSTEO RELIEF PARACETAMOL RF MP NP C6225 C6280 P6225 192 3 96

1. Schedule 1, Part 1, entry for Paracetamol in the form Tablet 665 mg (modified release) [Maximum Quantity: 192; Number of Repeats: 5]

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

a CHEMISTS' OWN OSTEO RELIEF PARACETAMOL RF MP NP C6225 C6280 P6280 192 5 96

1. Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C10683

(b)omit from the column headed “Circumstances”: C10697

1. Schedule 1, Part 1, entry for Pomalidomide

substitute:

Pomalidomide	Capsule 3 mg	Oral	Pomalyst	CJ	MP	See Note 3	See Note 3	See Note 3	See Note 3	14	D(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	21	D(100)
Capsule 4 mg	Oral	Pomalyst	CJ	MP	See Note 3	See Note 3	See Note 3	See Note 3	14	D(100)
MP	See Note 3	See Note 3	See Note 3	See Note 3	21	D(100)

1. Schedule 1, Part 1, entry for Risankizumab in the form Injection 75 mg in 0.83 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 1]

(a)insert in numerical order in the column headed “Circumstances”: C6696

(b)omit from the column headed “Circumstances”: C9986

(c)insert in numerical order in the column headed “Purposes”: P6696

(d)omit from the column headed “Purposes”: P9986

1. Schedule 1, Part 1, entry for Risankizumab in the form Injection 75 mg in 0.83 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

(a)insert in numerical order in the column headed “Circumstances”: C6696

(b)omit from the column headed “Circumstances”: C9986

1. Schedule 1, Part 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg in
   50 mL

omit from the column headed “Section 100/ Prescriber Bag only” (all instances): PB(100)       substitute: D(100)

1. Schedule 1, Part 1, entry for Rituximab

omit:

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL	Injection	Mabthera SC	RO	MP	C6011 C6161 C7399 C7400 C10227	P10227	1	2	1
MP	C6011 C6161 C7399 C7400 C10227	P7399	1	5	1
MP	C6011 C6161 C7399 C7400 C10227	P7400	1	6	1
MP	C6011 C6161 C7399 C7400 C10227	P6011	1	7	1
MP	C6011 C6161 C7399 C7400 C10227	P6161	1	11	1

1. Schedule 1, Part 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

insert in the column headed “Schedule Equivalent” (all instances): a

1. Schedule 1, Part 1, entry for Sertraline

omit:

Tablet 50 mg (as hydrochloride) (USP) Oral Sertraline tablets USP (Medsurge) DZ MP NP C4755 C6277 C6289 30 5 30

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

insert in the column headed “Schedule Equivalent” (all instances): a

1. Schedule 1, Part 1, entry for Sertraline

omit:

Tablet 100 mg (as hydrochloride) (USP) Oral Sertraline tablets USP (Medsurge) DZ MP NP C4755 C6277 C6289 30 5 30

1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

a NOUMED SIMVASTATIN VO MP NP 30 5 30

1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

a NOUMED SIMVASTATIN VO MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

a NOUMED SIMVASTATIN VO MP NP 30 5 30

1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

a NOUMED SIMVASTATIN VO MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

a NOUMED SIMVASTATIN VO MP NP 30 5 30

1. Schedule 1, Part 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

a NOUMED SIMVASTATIN VO MP P7598 30 11 30

1. Schedule 1, Part 1, entry for Sodium phenylbutyrate

omit from the column headed “Circumstances”: C9888

1. Schedule 1, Part 1, entry for Sunitinib

substitute:

Sunitinib	Capsule 12.5 mg	Oral	a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28
Capsule 25 mg	Oral	a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28
Capsule 37.5 mg	Oral	a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28
Capsule 50 mg	Oral	a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7430 P11878 P12319	28	1	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P4862	28	2	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P11875	28	3	28
a	Sunitinib Sandoz	SZ	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28
a	Sutent	PF	MP	C4862 C7430 C7471 C11875 C11878 C12319	P7471	28	5	28

1. Schedule 1, Part 1, entry for Terbinafine in the form Cream containing terbinafine hydrochloride 10 mg per g, 15 g

omit from the column headed “Responsible Person”: GK           substitute: GJ

1. Schedule 1, Part 1, entry for Terbutaline

omit:

Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses Inhalation by mouth Bricanyl Turbuhaler AP MP NP C9828 2 5 1

1. Schedule 1, Part 1, entry for Teriflunomide

omit:

a Aubagio GZ MP C10150 C10199 28 5 28

1. Schedule 1, Part 1, entry for Teriparatide

insert as first entry:

Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge Injection Terrosa FX MP C12269 C12270 1 5 1

1. Schedule 1, Part 1, entry for Testosterone in the form Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses

omit from the column headed “Responsible Person”: FP              substitute: IX

1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C11941

(b)insert in numerical order in the column headed “Circumstances”: C12317

1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C11941

(b)insert in numerical order in the column headed “Circumstances”: C12317

(c)omit from the column headed “Purposes”: P11941

(d)insert in numerical order in the column headed “Purposes”: P12317

1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C11941

(b)insert in numerical order in the column headed “Circumstances”: C12317

1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C11941

(b)insert in numerical order in the column headed “Circumstances”: C12317

(c)omit from the column headed “Purposes”: P11941

(d)insert in numerical order in the column headed “Purposes”: P12317

1. Schedule 1, Part 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C10131

(b)omit from the column headed “Purposes”: P10131

1. Schedule 1, Part 1, entry for Trametinib in the form Tablet 500 micrograms [Maximum Quantity: 90; Number of Repeats: 5]

omit from the column headed “Circumstances”: C10131

1. Schedule 1, Part 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C10131

(b)omit from the column headed “Purposes”: P10131

1. Schedule 1, entry for Trametinib in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit from the column headed “Circumstances”: C10131

1. Schedule 1, Part 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg; and Powder for I.V. infusion 150 mg

omit:

Herceptin RO MP C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296 See Note 3 See Note 3 1 PB(100)

1. Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 3]

(a)insert in numerical order in the column headed “Circumstances”: C9064 C9431

(b)insert in numerical order in the column headed “Circumstances”: C11886 C11944 C11945 C11956 C11978 C12090 C12091 C12142 C12184 C12223 C12246 C12342

(c)insert in numerical order in the column headed “Purposes”: P9064

(d)insert in numerical order in the column headed “Purposes”: P11944 P11945 P11956 P12090 P12091 P12184 P12246

1. Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 5]

(a)insert in numerical order in the column headed “Circumstances”: C9064 C9431

(b)insert in numerical order in the column headed “Circumstances”: C11886 C11944 C11945 C11956 C11978 C12090 C12091 C12142 C12184 C12223 C12246 C12342

(c)insert in numerical order in the column headed “Purposes”: P9431

(d)insert in numerical order in the column headed “Purposes”: P11886 P11978 P12142 P12223 P12342

1. Schedule 1, Part 1, entry for Ustekinumab

substitute:

Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Stelara	JC	MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11086 C11119 C11120 C11137 C11145 C11153 C11161 C12285 C12293 C12294 C12301 C12302 C12311 C12323 C12332 C12333 C12334 C12341	P12285	1	0	1
MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11086 C11119 C11120 C11137 C11145 C11153 C11161 C12285 C12293 C12294 C12301 C12302 C12311 C12323 C12332 C12333 C12334 C12341	P6696 P8891 P8987 P9063 P9116 P12293 P12301 P12302 P12311	1	1	1
MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11086 C11119 C11120 C11137 C11145 C11153 C11161 C12285 C12293 C12294 C12301 C12302 C12311 C12323 C12332 C12333 C12334 C12341	P9122 P9160 P9175 P9176 P11086 P11119 P11120 P11137 P11145 P11153 P11161 P12294 P12323 P12332 P12333 P12334 P12341	1	2	1
MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11086 C11119 C11120 C11137 C11145 C11153 C11161 C12285 C12293 C12294 C12301 C12302 C12311 C12323 C12332 C12333 C12334 C12341	P9655 P9656 P9657 P9710 P9711	2	0	1
Solution for I.V. infusion 130 mg in 26 mL	Injection	Stelara	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)

1. Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 20; Number of Repeats: 0]

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

a APX-Valaciclovir TY MP NP C5940 C5960 C5961 C5962 C5968 P5960 20 0 10

1. Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

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

a APX-Valaciclovir TY MP NP C5940 C5960 C5961 C5962 C5968 P5940 P5961 30 5 30

1. Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]

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

a APX-Valaciclovir TY MP NP C5940 C5960 C5961 C5962 C5968 P5962 P5968 42 0 42

1. Schedule 1, Part 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 500; Number of Repeats: 2]

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

a APX-Valaciclovir TY MP C5975 C9267 500 2 100 C(100)

1. Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

   insert in the column headed “Schedule Equivalent” (all instances): a

2. Schedule 1, Part 2, Ready‑prepared pharmaceutical benefits for supply only

substitute:

Part 2—Ready‑prepared pharmaceutical benefits for supply only

Note:              Section 9 (authorised prescribers) does not apply to pharmaceutical benefits listed in this Part.

Listed Drug

Form

Manner of Administration

Schedule Equivalent

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Pack Quantity

Determined Quantity

Section 100/ Prescriber Bag only

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

Bisacodyl

Enemas 10 mg in 5 mL, 25

Rectal

Bisalax

AS

MP NP

C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139

P6139

1

3

1

Suppositories 10 mg, 10

Rectal

a

Dulcolax

VZ

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139

P6139

3

3

1

a

Petrus Bisacodyl Suppositories

PP

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139

P6139

3

3

1

Suppositories 10 mg, 12

Rectal

Petrus Bisacodyl Suppositories

PP

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139

P6139

3

3

1

Tablet 5 mg

Oral

Lax‑Tab

AE

MP NP

C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139

P6139

200

3

200

Bortezomib

Powder for injection 1 mg

Injection

Velcade

JC

MP

C7940 C7941 C10338 C10426 C10454 C10455

See Note 3

See Note 3

1

D(100)

Powder for injection 3 mg

Injection

Velcade

JC

MP

C7938 C7939 C7940 C7941 C7960 C7961 C7962 C7974 C10338 C10426 C10454 C10455

See Note 3

See Note 3

1

D(100)

Powder for injection 3.5 mg

Injection

Velcade

JC

MP

C7938 C7939 C7960 C7961 C7962 C7974

See Note 3

See Note 3

1

D(100)

Dalteparin

Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

20

0

10

MP NP

P4910

20

3

10

Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

20

0

10

MP NP

P4910

20

3

10

Injection containing dalteparin sodium 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

10

1

10

MP NP

P4910

20

3

10

MP NP

P4967

30

5

10

Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

10

1

10

MP NP

P4910

20

3

10

MP NP

P4967

30

5

10

Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

10

1

10

MP NP

P4910

20

3

10

MP NP

P4967

30

5

10

Injection containing dalteparin sodium 15,000 I.U. (anti-Xa) in 0.6 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

C4967

30

5

10

Injection containing dalteparin sodium 18,000 I.U. (anti-Xa) in 0.72 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

C4967

30

5

10

Darunavir

Tablet 150 mg (as ethanolate)

Oral

Prezista

JC

MP

C5094

240

5

240

D(100)

Diclofenac

Suppository containing diclofenac sodium 100 mg

Rectal

Voltaren 100

NV

MP NP

P6149

40

3

20

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

a

APO-Diclofenac

TX

MP NP

C6149

100

3

50

a

Clonac 25

RW

MP NP

C6149

100

3

50

a

Diclofenac Amneal

ED

MP NP

C6149

100

3

50

a

Diclofenac AN

EA

MP NP

C6149

100

3

50

a

Diclofenac Sandoz

SZ

MP NP

C6149

100

3

50

a

Fenac 25

AF

MP NP

C6149

100

3

50

a

Voltaren 25

NV

MP NP

C6149

100

3

50

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

a

Pharmacor Diclofenac 50

CR

PDP

C6256 C6282

50

0

50

a

APO-Diclofenac

TX

MP NP

C6149

50

3

50

a

Clonac 50

RW

MP NP

C6149

50

3

50

a

Diclofenac Amneal

ED

MP NP

C6149

50

3

50

a

Diclofenac AN

EA

MP NP

C6149

50

3

50

a

Diclofenac Sandoz

SZ

MP NP

C6149

50

3

50

a

Fenac

AF

MP NP

C6149

50

3

50

a

Pharmacor Diclofenac 50

CR

MP NP

C6149

50

3

50

a

Voltaren 50

NV

MP NP

C6149

50

3

50

Enfuvirtide

Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)

Injection

Fuzeon

RO

MP NP

C5014

2

5

1

D(100)

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

Exenatide

Injection (modified release) 2 mg single dose pre-filled pen

Injection

Bydureon

AP

MP NP

C6505 C6519

4

5

4

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

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral semi-solid 100 g, 48 (Keyo)

Oral

Keyo

VF

MP NP

C6858

3

5

1

Indometacin

Suppository 100 mg

Rectal

Indocid

AS

MP NP

P6149

40

3

20

Ketoconazole

Shampoo 10 mg per g, 100 mL

Application

Nizoral 1%

JT

MP NP

C6434

1

1

1

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

a

lax-sachets

AE

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

1

5

1

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

2

3

1

Mesalazine

Sachet containing prolonged release granules, 1 g per sachet

Oral

Pentasa

FP

MP NP

C9443 C9444

120

5

120

Suppository 1 g

Rectal

Pentasa

FP

MP NP

C4878

30

1

30

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

Naproxen

Tablet 500 mg

Oral

Naprosyn

IX

PDP

C6256 C6282

50

0

50

MP NP

C6149 C6214 C6283

50

3

50

Nitrazepam

Tablet 5 mg

Oral

a

Alodorm

AF

MP NP PDP

25

0

25

MP NP

P6175

50 CN6175

3 CN6175

25

MP NP

P5661 P5771 P5941 P5950

50 CN5661 CN5771 CN5941 CN5950

5 CN5661 CN5771 CN5941 CN5950

25

Olaparib

Capsule 50 mg

Oral

Lynparza

AP

MP

C10937

448

5

448

Phenoxybenzamine

Capsule containing 10 mg phenoxybenzamine hydrochloride

Oral

Dibenzyline

BZ

MP NP

C6145 C6178

100

5

100

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

Terbutaline

Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 100 doses

Inhalation by mouth

Bricanyl Turbuhaler

AP

MP NP

C9828

2

5

1

Testosterone

Transdermal patches 12.2 mg, 60

Transdermal

Androderm

TB

MP

C6324 C6910 C6919 C6933 C6934

1

5

1

Verapamil

Tablet containing verapamil hydrochloride 40 mg

Oral

Anpec 40

AF

MP NP

100

5

100

1. Schedule 3, details relevant to Responsible Person code EV

omit from the column headed “Responsible Person”: Teva Pharma Australia Pty Limited                  substitute: Teva Pharma Australia Pty Ltd

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

insert:

GJ GlaxoSmithKline Consumer Healthcare Australia Pty Ltd 68 603 310 292

1. Schedule 3

omit:

HN Horizon Hospital Healthcare Pty Ltd 60 148 910 883

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

insert:

HT BTC Speciality Health Pty Ltd 28 621 706 929

1. Schedule 3, details relevant to Responsible Person code TB

omit from the column headed “Responsible Person”: Teva Pharma Australia Pty Limited                  substitute: Teva Pharma Australia Pty Ltd

1. Schedule 3,

omit:

XA Pharmaxis Ltd 75 082 811 630

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

insert:

XN Southern XP Pty Ltd 34 639 505 481

1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C6696	P6696	Severe chronic plaque psoriasis Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND The treatment must be as systemic monotherapy (other than methotrexate). Must be treated by a dermatologist.	Compliance with Authority Required procedures
C6946	P6946	Moderate to severe hidradenitis suppurativa Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment – balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial treatment 1 - New patient restriction to complete a maximum of 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial treatment 2 - Recommencement of treatment restriction to complete a maximum of 16 weeks treatment. Must be treated by a dermatologist. A maximum of 12 weeks of treatment will be authorised under this restriction.	Compliance with Authority Required procedures
C6963	P6963	Moderate to severe hidradenitis suppurativa Initial treatment 2 - Recommencement of treatment Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND The treatment must be limited to a maximum duration of 16 weeks. Must be treated by a dermatologist. Assessment of disease severity must be no more than 1 month old at the time of application. A response to treatment is defined as: Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae. An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment. At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include: (i) the Hurley stage grading; and (ii) the AN count.	Compliance with Written Authority Required procedures
C8608	P8608	Complex refractory Fistulising Crohn disease Continuing treatment - balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.	Compliance with Authority Required procedures
C8627	P8627	Severe active rheumatoid arthritis Continuing Treatment - balance of supply. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.	Compliance with Authority Required procedures
C8631	P8631	Severe active rheumatoid arthritis Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures

(b)omit:

C8678	P8678	Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.	Compliance with Written Authority Required procedures
C8702	P8702	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C9063	P9063	Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.	Compliance with Authority Required procedures

(c)omit:

C9069	P9069	Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C9078	P9078	Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C9155	P9155	Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C9380	P9380	Severe active juvenile idiopathic arthritis Continuing Treatment - balance of supply Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.	Compliance with Authority Required procedures

C12342 P12342 Severe psoriatic arthritis
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received treatment with this drug for this PBS indication prior to 1 October 2021; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months prior to initiating non-PBS subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response following at least 12 weeks of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice); and
(3) the date of commencement of this drug; and
(4) results of the baseline patient assessment prior to initiation of non-PBS subsidised therapy with this drug. Compliance with Written Authority Required procedures

1. Schedule 4, Part 1, entry for Ustekinumab

insert in numerical order after existing text:

C12285	P12285	Severe chronic plaque psoriasis Balance of supply - Continuing treatment (Whole body, or, face/hand/foot) Must be treated by a dermatologist; AND Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but the full number of repeats available under the continuing treatment phase was not prescribed.	Compliance with Authority Required procedures
C12293	P12293	Severe chronic plaque psoriasis Transitioning from non-PBS to PBS-subsidised supply (Face, hand, foot) - 'Grandfather' arrangements Must be treated by a dermatologist. Patient must be receiving treatment with this biological medicine at the time of this application, with initiation of this biological medicine having commenced prior to 1 October 2021; AND The treatment must be in a patient who prior to initiating treatment with non-PBS-subsidised treatment with this biological medicine, was each of: (i) treatment-naive to this biological medicine, (ii) had psoriatic lesions present on the face/hand/foot for at least 6 months from the time of initial diagnosis; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have, prior to having initiated non-PBS-subsidised treatment with this biological medicine, failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or (b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy State in this authority application, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined State in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment: (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.	Compliance with Written Authority Required procedures
C12294	P12294	Severe chronic plaque psoriasis Initial 2 treatment (Face, hand, foot) - Change or recommencement of treatment after a break in biological medicine of less than 5 years Must be treated by a dermatologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Response to preceding supply: An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. Change in therapy: If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because: (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above Recommencing therapy: If the patient is recommencing therapy, in relation to the last administered dose, state whether there was: (i) an absence of an adequate response; or (ii) an intolerance to that treatment; or (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.	Compliance with Written Authority Required procedures
C12301	P12301	Severe chronic plaque psoriasis Transitioning from non-PBS to PBS-subsidised supply (Whole body) - 'Grandfather' arrangements Must be treated by a dermatologist. Patient must be receiving treatment with this biological medicine at the time of this application, with initiation of this biological medicine having commenced prior to 1 October 2021; AND The treatment must be in a patient who prior to initiating treatment with non-PBS subsidised treatment with this biological medicine, was each of: (i) treatment-naive to this biological medicine, (ii) had psoriatic lesions present for at least 6 months from the time of initial diagnosis; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have, prior to having initiated non-PBS-subsidised treatment with this biological medicine, failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy. A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. State in this authority application, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined State a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.	Compliance with Written Authority Required procedures
C12302	P12302	Severe chronic plaque psoriasis Continuing treatment (Face, hand, foot) - treatment covering week 28 and onwards Must be treated by a dermatologist. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.	Compliance with Written Authority Required procedures
C12311	P12311	Severe chronic plaque psoriasis Continuing treatment (Whole body) - treatment covering week 28 and onwards Must be treated by a dermatologist. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.	Compliance with Written Authority Required procedures
C12323	P12323	Severe chronic plaque psoriasis Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years Must be treated by a dermatologist. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; OR The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; OR The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C12332	P12332	Severe chronic plaque psoriasis Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years Must be treated by a dermatologist. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Response to preceding supply: An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. Change in therapy: If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because: (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above Recommencing therapy: If the patient is recommencing therapy, in relation to the last administered dose, state whether there was: (i) an absence of an adequate response; or (ii) an intolerance to that treatment; or (iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.	Compliance with Written Authority Required procedures
C12333	P12333	Severe chronic plaque psoriasis Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient Must be treated by a dermatologist. Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or (b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy State in this authority application, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined State in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment: (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.	Compliance with Written Authority Required procedures
C12334	P12334	Severe chronic plaque psoriasis Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot) Must be treated by a dermatologist; AND Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 3 doses available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3. The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND The treatment must provide no more than the balance of 3 doses available under any of the initial treatment phases.	Compliance with Authority Required procedures
C12341	P12341	Severe chronic plaque psoriasis Initial 1 treatment (Whole body) - biological medicine-naive patient Must be treated by a dermatologist. Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; OR The treatment must be in combination with methotrexate; AND Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; and/or (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy: (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy. A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. State in this authority application, each of: (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined State a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.	Compliance with Written Authority Required procedures

1. Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [GRP-25058]

omit from the column headed “Brand”: Humira

1. Schedule 5, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [GRP-25059]

omit from the column headed “Brand”: Humira

1. Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [GRP-25060]

omit from the column headed “Brand”: Humira

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

insert:

Darunavir	GRP-24212	Tablet 600 mg	Oral	Darunavir Juno
Tablet 600 mg (as ethanolate)	Oral	Prezista
GRP-25566	Tablet 800 mg	Oral	Darunavir Juno
Tablet 800 mg (as ethanolate)	Oral	Prezista

1. Schedule 5, after entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

insert:

Nitrofurantoin	GRP-25565	Capsule 50 mg	Oral	APO-Nitrofurantoin Macrodantin
Capsule 50 mg, USP	Oral	Nitrofurantoin Capsules, USP, (Macrocrystals)

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

omit from the column headed “Brand”: Ramace 5 mg

1. Schedule 5, entry for Ramipril in the form Capsule 10 mg [GRP-15431]

omit from the column headed “Brand”: Ramace 10 mg

1. Schedule 5, entry for Ramipril in the form Tablet 1.25 mg [GRP-15640]

omit from the column headed “Brand”: Ramace 1.25 mg

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

omit from the column headed “Brand”: Ramace 2.5 mg

1. Schedule 5, omit entry for Sertraline

1. Schedule 5, after entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg

insert:

Teriparatide	GRP-25564	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge	Injection	Terrosa
Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen	Injection	Forteo

1. Schedule 5, omit entry for Zoledronic acid