National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 12) (Cth)

PB 112 of 2023

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023
(No. 12)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, 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 30 November 2023

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1
2......... Commencement............................................................................................................... 1
3......... Authority......................................................................................................................... 1
4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments 2

National Health (Listing of Pharmaceutical Benefits) Instrument 2012
(PB 71 of 2012). 2

Name

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 12).

(2)This Instrument may also be cited as PB 112 of 2023.

Commencement

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

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 December 2023	1 December 2023

Note: This table relates only to the provisions of this instrument as originally made.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.

Authority

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

4 Schedules

Each instrument that is specified in a Schedule 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)

Schedule 1, Part 1, entry for Adalimumab

substitute:

Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11713	2	0	2
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P9715 P11715 P11716 P11761 P11852 P11854 P11855	2	3	2
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11717 P11767 P11853 P11903 P11966	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Amgevita	XT	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11713	2	0	1
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P9715 P11715 P11716 P11761 P11852 P11854 P11855	2	3	1
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11579 P11717 P11718 P11767 P11853 P11903 P11966	2	5	1
MP	C14107 C14136	2	5	1	C(100)
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)
Yuflyma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P11713	2	0	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14498 P14655 P14662 P14670	2	3	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P11704 P11711 P11717 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14656 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P12273	4	2	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P12273	4	2	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P12272 P12315	4	5	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11529 P12272 P12315	4	5	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Yuflyma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P11713	2	0	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14498 P14655 P14662 P14670	2	3	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P11704 P11711 P11717 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14656 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Humira	VE	MP	C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14655 C14656 C14662 C14670 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Yuflyma	EW	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Injection 40 mg in 0.8 mL pre-filled pen	Injection	Amgevita	XT	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	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P12273	4	2	2

Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P12273	4	2	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P12273	4	2	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P12273	4	2	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11529 P12272 P12315	4	5	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11529 P12272 P12315	4	5	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11529 P12272 P12315	4	5	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11529 P12272 P12315	4	5	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C12272 C12273 C12275 C12315 C12336 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Amgevita	XT	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	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11713	2	0	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673	2	3	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Amgevita	XT	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Hadlima	RF	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Hyrimoz	SZ	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Idacio	PK	MP	C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11759 C11761 C11767 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12189 C12190 C12194 C12212 C12214 C12228 C12240 C13556 C13599 C13602 C13609 C13612 C13650 C13681 C13694 C14377 C14378 C14483 C14486 C14488 C14493 C14496 C14498 C14499 C14507 C14567 C14568 C14590 C14655 C14656 C14662 C14670 C14672 C14673 C14683 C14701 C14713 C14730	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Injection 80 mg in 0.8 mL pre-filled pen	Injection	Humira	VE	MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12103 P12105 P12155 P12212 P14398 P14399	1	0	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12273	2	2	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12306	2	5	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278	3	0	1
Injection 80 mg in 0.8 mL pre-filled syringe	Injection	Humira	VE	MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12103 P12105 P12155 P12212 P14398 P14399	1	0	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12273	2	2	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12306	2	5	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278	3	0	1

Schedule 1, Part 1, after entry for Adefovir in the form Tablet containing adefovir dipivoxil 10 mg

insert:

Tablet containing adefovir dipivoxil 10 mg (S19A)

Oral

Adefovir Dipivoxil Tablets 10 mg (SigmaPharm Laboratories)

MP NP

C4490 C4510

D(100)

Schedule 1, Part 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

(a) omit:

Alendronate Plus D3 Sandoz

MP NP

C6307 C6315 C6320

(b) omit from the column headed “Schedule Equivalent” for the brand “Fosamax Plus”: a

Schedule 1, Part 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

(a)omit:

Alendronate Plus D3 Sandoz

MP NP

C6306 C6319 C6325

(b)omit from the column headed “Schedule Equivalent” for the brand “Fosamax Plus 70 mg/140 mcg”: a

Schedule 1, Part 1, entry for Amisulpride in the form Tablet 400 mg

omit:

Amisulpride 400 Winthrop

MP NP

C4246

Schedule 1, Part 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg

omit:

Amitriptyline Alphapharm 25

MP NP

Schedule 1, Part 1, entry for Amoxicillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]

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

Blooms The Chemist Amoxicillin

MP NP MW PDP

Schedule 1, Part 1, entry for c in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 40; Number of Repeats: 0]

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

Blooms The Chemist Amoxicillin

MP NP

P10402

40
CN10402

0
CN10402

Schedule 1, Part 1, entry for Amoxicillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

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

Schedule 1, Part 1, entry for Amoxicillin

omit:

Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL (s19A)	Oral	Amoxicillin 250mg/ 5 ml Oral Suspension Sugar Free BP (Kent)	RQ	PDP	1	0	1
MP NP	1	0	1

Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

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

Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125	BG	MP NP	C5832 C5893 C10413	P5832 P5893	10	0	10
PDP	C5833 C5894	10	0	10

Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 20; Number of Repeats: 0]

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

Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125

MP NP

C5832 C5893 C10413

P10413

Schedule 1, Part 1, entry for Bimekizumab in the form Injection 160 mg in 1 mL single use pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C14438

(b)insert in numerical order in the column headed “Circumstances”: C14726

(c)omit from the column headed “Purposes”: P14438

(d)insert in numerical order in the column headed “Purposes”: P14726

Schedule 1, Part 1, entry for Bimekizumab in the form Injection 160 mg in 1 mL single use pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]

(a)omit from the column headed “Circumstances”: C14438

(b)insert in numerical order in the column headed “Circumstances”: C14726

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 5 mg

substitute:

Transdermal patch 5 mg	Transdermal	a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 10 mg

substitute:

Transdermal patch 10 mg	Transdermal	a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 15 mg

substitute:

Transdermal patch 15 mg	Transdermal	a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 20 mg

substitute:

Transdermal patch 20 mg	Transdermal	a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P10748 P10752 P10755	2	0	2
a	B-Patch	IU	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Bupredermal	TX	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Buprenorphine Sandoz	SZ	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2
a	Norspan	MF	MP NP	C10748 C10752 C10755 C11753	P11753	4	0	2

Schedule 1, Part 1, entry for Carboplatin

omit:

DBL Carboplatin

See Note 3

D(100)

Schedule 1, Part 1, entry for Cefepime in the form Powder for injection 2 g (as hydrochloride)

omit:

Cefepime-AFT

MP NP

C5842

Schedule 1, Part 1, entry for Certolizumab pegol

substitute:

Certolizumab pegol	Injection 200 mg in 1 mL single use pre-filled syringe	Injection	Cimzia	UC	MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P10459 P12392	2	0	2
MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P9185 P9625 P14542	2	2	2
MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P9063 P9105 P9431 P10431 P14493 P14499 P14507 P14692	2	5	2
MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P9073 P9074 P9183 P10513 P11386 P14191 P14571 P14591 P14622 P14659 P14686 P14714	6	0	2
Solution for injection 200 mg in 1 mL pre-filled pen	Injection	Cimzia	UC	MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P10459 P12392	2	0	2
MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P9185 P9625 P14542	2	2	2
MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P9063 P9105 P9431 P10431 P14493 P14499 P14507 P14692	2	5	2
MP	C9063 C9073 C9074 C9105 C9183 C9185 C9431 C9625 C10431 C10459 C10513 C11386 C12392 C14191 C14493 C14499 C14507 C14542 C14571 C14591 C14622 C14659 C14686 C14692 C14714	P9073 P9074 P9183 P10513 P11386 P14191 P14571 P14591 P14622 P14659 P14686 P14714	6	0	2

Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [Maximum Quantity: 28; Number of Repeats: 5]

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

Blooms Clopidogrel

MP NP

Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [Maximum Quantity: 56; Number of Repeats: 5]

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

Blooms Clopidogrel

MP NP

P14238

Schedule 1, Part 1, entry for Colestyramine

omit:

Sachet containing 4 g oral powder (s19A)	Oral	JAMP-Cholestyramine	DZ	MP NP	100	5	30
MP	P6429	100	11	30

Schedule 1, Part 1, entry for Cyclophosphamide in each of the forms: Powder for injection 500 mg (anhydrous); and Powder for injection 1 g (anhydrous)

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

CYCLOPHOSPHAMIDE-REACH

See Note 3

PB(100)

Schedule 1, Part 1, entry for Dabigatran etexilate

substitute:

Dabigatran etexilate	Capsule 75 mg (as mesilate)	Oral	a	PHARMACOR DABIGATRAN	CR	MP NP	C4369 C4381 C4402	P4381	20	0	10
a	Pradaxa	BY	MP NP	C4369 C4381 C4402	P4381	20	0	10
a	PHARMACOR DABIGATRAN	CR	MP NP	C4369 C4381 C4402	P4369	20	1	10
a	Pradaxa	BY	MP NP	C4369 C4381 C4402	P4369	20	1	10
a	PHARMACOR DABIGATRAN	CR	MP NP	C4369 C4381 C4402	P4402	60	0	60
a	Pradaxa	BY	MP NP	C4369 C4381 C4402	P4402	60	0	60
Capsule 110 mg (as mesilate)	Oral	a	PHARMACOR DABIGATRAN	CR	MP NP	C4269 C4369 C4381 C4402 C14308	P4381	20	0	10
a	Pradaxa	BY	MP NP	C4269 C4369 C4381 C4402 C14308	P4381	20	0	10
a	PHARMACOR DABIGATRAN	CR	MP NP	C4269 C4369 C4381 C4402 C14308	P4369	20	1	10
a	Pradaxa	BY	MP NP	C4269 C4369 C4381 C4402 C14308	P4369	20	1	10
a	Dabigatran Sandoz	SZ	MP NP	C4269 C4402 C14308	P4402	60	0	60
a	PHARMACOR DABIGATRAN	CR	MP NP	C4269 C4369 C4381 C4402 C14308	P4402	60	0	60
a	Pradaxa	BY	MP NP	C4269 C4369 C4381 C4402 C14308	P4402	60	0	60
a	Dabigatran Sandoz	SZ	MP NP	C4269 C4402 C14308	P4269	60	5	60
a	PHARMACOR DABIGATRAN	CR	MP NP	C4269 C4369 C4381 C4402 C14308	P4269	60	5	60
a	Pradaxa	BY	MP NP	C4269 C4369 C4381 C4402 C14308	P4269	60	5	60
a	Dabigatran Sandoz	SZ	MP NP	C4269 C4402 C14308	P14308	120	5	60
a	PHARMACOR DABIGATRAN	CR	MP NP	C4269 C4369 C4381 C4402 C14308	P14308	120	5	60
a	Pradaxa	BY	MP NP	C4269 C4369 C4381 C4402 C14308	P14308	120	5	60
Capsule 150 mg (as mesilate)	Oral	a	Dabigatran Sandoz	SZ	MP NP	C4269 C14308	P4269	60	5	60
a	PHARMACOR DABIGATRAN	CR	MP NP	C4269 C14308	P4269	60	5	60
a	Pradaxa	BY	MP NP	C4269 C14308	P4269	60	5	60
a	Dabigatran Sandoz	SZ	MP NP	C4269 C14308	P14308	120	5	60
a	PHARMACOR DABIGATRAN	CR	MP NP	C4269 C14308	P14308	120	5	60
a	Pradaxa	BY	MP NP	C4269 C14308	P14308	120	5	60

Schedule 1, Part 1, entry for Darolutamide

insert in numerical order in the column headed “Circumstances”: C14034

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

omit from the column headed “Circumstances”: C10126 C12271 substitute: C10126 C10206 C10509 C12271 C14708

Schedule 1, Part 1, entry for Entecavir in the form Tablet 1 mg (as monohydrate)

omit:

ENTAC

MP NP

C5037 C5044

D(100)

Schedule 1, Part 1, entry for Essential amino acids formula with vitamins and minerals

substitute:

Essential amino acids formula with vitamins and minerals

Sachets containing oral powder 12.5 g, 30 (EAA Supplement)

Oral

EAA Supplement

MP NP

C4925 C4958

Schedule 1, Part 1, omit entry for Estradiol with dydrogesterone

Schedule 1, Part 1, entry for Etanercept

substitute:

Etanercept	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P14508 P14509	2	1	1
MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P9064 P9386 P9388 P9473 P11107 P12164 P12261 P13532 P13533 P13538 P13593 P13598 P13646 P13647 P14382 P14427 P14483 P14486 P14488 P14498 P14513 P14552 P14553 P14554 P14576 P14577 P14600 P14655 P14662 P14670 P14703	2	3	1
MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P7289 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P14493 P14499 P14507 P14656 P14713 P14715	2	5	1
MP	C14154 C14155	2	5	1	C(100)
Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P14508 P14509	1	1	1
Brenzys	RF	MP	C7289 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C11107 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14581 C14582 C14603 C14629 C14655 C14656 C14662 C14670 C14671 C14673 C14683 C14701 C14703 C14713 C14715	P9064 P11107 P13532 P13533 P13538 P13593 P13598 P13646 P13647 P14382 P14427 P14483 P14486 P14488 P14498 P14581 P14582 P14603 P14655 P14662 P14670 P14671 P14673 P14703	1	3	1
Enbrel	PF	MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P9064 P9386 P9388 P9473 P11107 P12164 P12261 P13532 P13533 P13538 P13593 P13598 P13646 P13647 P14382 P14427 P14483 P14486 P14488 P14498 P14513 P14552 P14553 P14554 P14576 P14577 P14600 P14655 P14662 P14670 P14703	1	3	1
Brenzys	RF	MP	C7289 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C11107 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14581 C14582 C14603 C14629 C14655 C14656 C14662 C14670 C14671 C14673 C14683 C14701 C14703 C14713 C14715	P7289 P8839 P8842 P8873 P8879 P8887 P8955 P9081 P9123 P9140 P9156 P9162 P14493 P14499 P14507 P14629 P14656 P14683 P14701 P14713 P14715	1	5	1
Enbrel	PF	MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P7289 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P14493 P14499 P14507 P14656 P14713 P14715	1	5	1
MP	C14154 C14155	1	5	1	C(100)
Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P14508 P14509	1	1	1
Brenzys	RF	MP	C7289 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C11107 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14581 C14582 C14603 C14629 C14655 C14656 C14662 C14670 C14671 C14673 C14683 C14701 C14703 C14713 C14715	P9064 P11107 P13532 P13533 P13538 P13593 P13598 P13646 P13647 P14382 P14427 P14483 P14486 P14488 P14498 P14581 P14582 P14603 P14655 P14662 P14670 P14671 P14673 P14703	1	3	1
Enbrel	PF	MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P9064 P9386 P9388 P9473 P11107 P12164 P12261 P13532 P13533 P13538 P13593 P13598 P13646 P13647 P14382 P14427 P14483 P14486 P14488 P14498 P14513 P14552 P14553 P14554 P14576 P14577 P14600 P14655 P14662 P14670 P14703	1	3	1
Brenzys	RF	MP	C7289 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C11107 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14581 C14582 C14603 C14629 C14655 C14656 C14662 C14670 C14671 C14673 C14683 C14701 C14703 C14713 C14715	P7289 P8839 P8842 P8873 P8879 P8887 P8955 P9081 P9123 P9140 P9156 P9162 P14493 P14499 P14507 P14629 P14656 P14683 P14701 P14713 P14715	1	5	1
Enbrel	PF	MP	C7289 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9473 C11107 C12164 C12261 C13532 C13533 C13538 C13593 C13598 C13646 C13647 C14382 C14427 C14483 C14486 C14488 C14493 C14498 C14499 C14507 C14508 C14509 C14513 C14552 C14553 C14554 C14576 C14577 C14600 C14655 C14656 C14662 C14670 C14703 C14713 C14715	P7289 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P14493 P14499 P14507 P14656 P14713 P14715	1	5	1
MP	C14154 C14155	1	5	1	C(100)

Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate)

substitute:

Lozenge 600 micrograms (as citrate)

Buccal

Actiq

MP NP

C5904

Schedule 1, Part 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate)

substitute:

Lozenge 800 micrograms (as citrate)

Buccal

Actiq

MP NP

C5904

Schedule 1, Part 1, entry for Fentanyl

omit:

Lozenge 1200 micrograms (as citrate)	Buccal	Actiq	TB	MP NP	C5904 C5915	P5915	9	0	9
MP NP	C5904 C5915	P5904	60	0	30
Lozenge 1600 micrograms (as citrate)	Buccal	Actiq	TB	MP NP	C5904 C5915	P5915	9	0	9
MP NP	C5904 C5915	P5904	60	0	30

Schedule 1, Part 1, entry for Fentanyl in the form Tablet (orally disintegrating) 400 micrograms (as citrate)

substitute:

Tablet (orally disintegrating) 400 micrograms (as citrate)

Buccal

Fentora

MP NP

C6027

Schedule 1, Part 1, entry for Fentanyl in the form Tablet (orally disintegrating) 600 micrograms (as citrate)

substitute:

Tablet (orally disintegrating) 600 micrograms (as citrate)

Buccal

Fentora

MP NP

C6027

Schedule 1, Part 1, entry for Fentanyl in the form Tablet (orally disintegrating) 800 micrograms (as citrate)

substitute:

Tablet (orally disintegrating) 800 micrograms (as citrate)

Buccal

Fentora

MP NP

C6027

Schedule 1, Part 1, entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single-use pre-filled syringe

omit:

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

D(100)

Schedule 1, Part 1, entry for Filgrastim

omit:

Injection 300 micrograms in 1 mL

Injection

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

D(100)

Schedule 1, Part 1, entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single-use pre-filled syringe

omit:

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

D(100)

Schedule 1, Part 1, entry for Filgrastim

omit:

Injection 480 micrograms in 1.6 mL

Injection

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

D(100)

Schedule 1, Part 1, entry for Fluorouracil in the form Injection 2500 mg in 50 mL

omit:

DBL Fluorouracil Injection BP

C6266 C6297

See Note 3

D(100)

Schedule 1, Part 1, entry for Golimumab

substitute:

Golimumab	Injection 50 mg in 0.5 mL single use pre-filled pen	Injection	Simponi	JC	MP	C9063 C9064 C9069 C9105 C9153 C9155 C9429 C9431 C10434 C10436 C10461 C10515 C11431 C14190 C14488 C14507 C14519 C14556 C14557 C14604 C14626 C14655 C14662 C14670 C14692	P9064 P9069 P9153 P9155 P9429 P10436 P10515 P11431 P14190 P14488 P14556 P14557 P14626 P14655 P14662 P14670	1	3	1
MP	C9063 C9064 C9069 C9105 C9153 C9155 C9429 C9431 C10434 C10436 C10461 C10515 C11431 C14190 C14488 C14507 C14519 C14556 C14557 C14604 C14626 C14655 C14662 C14670 C14692	P9063 P9105 P9431 P10434 P10461 P14507 P14519 P14604 P14692	1	5	1
Injection 50 mg in 0.5 mL single use pre-filled syringe	Injection	Simponi	JC	MP	C9063 C9064 C9069 C9105 C9153 C9155 C9429 C9431 C10434 C10436 C10461 C10515 C11431 C14190 C14488 C14507 C14519 C14556 C14557 C14604 C14626 C14655 C14662 C14670 C14692	P9064 P9069 P9153 P9155 P9429 P10436 P10515 P11431 P14190 P14488 P14556 P14557 P14626 P14655 P14662 P14670	1	3	1
MP	C9063 C9064 C9069 C9105 C9153 C9155 C9429 C9431 C10434 C10436 C10461 C10515 C11431 C14190 C14488 C14507 C14519 C14556 C14557 C14604 C14626 C14655 C14662 C14670 C14692	P9063 P9105 P9431 P10434 P10461 P14507 P14519 P14604 P14692	1	5	1
Injection 100 mg in 1 mL single use pre-filled pen	Injection	Simponi	JC	MP	C9651 C9705 C9745 C9770 C9822 C9823	P9745	1	1	1
MP	C9651 C9705 C9745 C9770 C9822 C9823	P9651 P9770	1	5	1
MP	C9651 C9705 C9745 C9770 C9822 C9823	P9705 P9822 P9823	3	0	1

Schedule 1, Part 1, entry for Ibandronic acid

omit:

Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL

Injection

Bondronat

C5291 C9333

PB(100)

Schedule 1, Part 1, entry for Imatinib in the form Capsule 100 mg (as mesilate)

(a)omit:

CIPLA IMATINIB ADULT

C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543

P9203 P9207 P12525 P12527 P12542 P12543

(b)omit:

CIPLA IMATINIB ADULT

C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543

P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541

Schedule 1, Part 1, entry for Imatinib in the form Capsule 400 mg (as mesilate)

(a)omit:

CIPLA IMATINIB ADULT

C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543

P9203 P9207 P12525 P12527 P12542 P12543

(b)omit:

CIPLA IMATINIB ADULT

C9203 C9204 C9206 C9207 C9209 C9240 C9243 C9274 C9276 C9296 C12525 C12527 C12536 C12541 C12542 C12543

P9204 P9206 P9209 P9240 P9243 P9274 P9276 P9296 P12536 P12541

Schedule 1, Part 1, entry for Infliximab

substitute:

Infliximab	Powder for I.V. infusion 100 mg	Injection	Inflectra	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
Remicade	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
Renflexis	OQ	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)
Inflectra	PF	MP	C14504 C14505 C14585 C14638 C14683 C14689 C14701 C14723	P14504 P14505 P14585 P14638	3	2	1	PB(100)
Remicade	JC	MP	C14504 C14505	3	2	1	PB(100)
Renflexis	OQ	MP	C14504 C14505 C14585 C14638 C14683 C14689 C14701 C14723	P14504 P14505 P14585 P14638	3	2	1	PB(100)
Inflectra	PF	MP	C14504 C14505 C14585 C14638 C14683 C14689 C14701 C14723	P14683 P14689 P14701 P14723	5	3	1	PB(100)
Renflexis	OQ	MP	C14504 C14505 C14585 C14638 C14683 C14689 C14701 C14723	P14683 P14689 P14701 P14723	5	3	1	PB(100)
Solution for injection 120 mg in 1 mL pre-filled pen	Injection	Remsima SC	EW	MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P13104	1	0	1
MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P13040 P13058 P13061 P13068 P13094 P13096	2	0	1
MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P13039 P13045 P13069 P13077 P13078 P13080 P13097	2	2	1
MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P11826 P11910 P13043 P13056 P13079 P14515 P14668	2	5	1
Solution for injection 120 mg in 1 mL pre-filled syringe	Injection	Remsima SC	EW	MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P13104	1	0	1
MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P13040 P13058 P13061 P13068 P13094 P13096	2	0	1
MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P13039 P13045 P13069 P13077 P13078 P13080 P13097	2	2	1
MP	C11826 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13096 C13097 C13104 C14515 C14668	P11826 P11910 P13043 P13056 P13079 P14515 P14668	2	5	1

Schedule 1, Part 1, entry for Insulin neutral with insulin isophane

omit:

Injections (human), cartridges, 50 units-50 units per mL, 3 mL, 5

Injection

Mixtard 50/50 Penfill 3 mL

MP NP

Schedule 1, Part 1, entry for Ixekizumab

substitute:

Ixekizumab	Injection 80 mg in 1 mL single dose pre-filled pen	Injection	Taltz	LY	MP	C6696 C8830 C8892 C9172 C9429 C9431 C11089 C11096 C11107 C11138 C11154 C11834 C11918 C11958 C11959 C11981 C14453 C14461 C14655 C14662 C14670 C14692	P9429 P14655 P14662 P14670	2	1	2
MP	C6696 C8830 C8892 C9172 C9429 C9431 C11089 C11096 C11107 C11138 C11154 C11834 C11918 C11958 C11959 C11981 C14453 C14461 C14655 C14662 C14670 C14692	P6696 P8830 P8892 P9172 P9431 P11834 P11918 P11958 P11959 P11981 P14692	2	2	2
MP	C6696 C8830 C8892 C9172 C9429 C9431 C11089 C11096 C11107 C11138 C11154 C11834 C11918 C11958 C11959 C11981 C14453 C14461 C14655 C14662 C14670 C14692	P11089 P11096 P11107 P11138 P11154 P14453 P14461	2	3	2

Schedule 1, Part 1, entry for Macrogol 3350

substitute:

Macrogol 3350	Powder for oral solution 510 g	Oral	OsmoLax	KY	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
MP NP	C4171 C4173 C4177 C4179 C4180 C6170	P4171 P4173 P4177 P4179 P4180	1	5	1
MP NP	C4171 C4173 C4177 C4179 C4180 C6170	P6170	2	3	1
Sachets containing powder for oral solution 13.125 g with electrolytes, 30	Oral	a	APOHEALTH Macrogol with Electrolytes	GX	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	APO-MACROGOL plus ELECTROLYTES	TX	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Chemists' Own Macrogol with Electrolytes	RW	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Macrovic	RF	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Molaxole	GO	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Movicol	NE	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	APOHEALTH Macrogol with Electrolytes	GX	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	APO-MACROGOL plus ELECTROLYTES	TX	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Chemists' Own Macrogol with Electrolytes	RW	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Macrovic	RF	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Molaxole	GO	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Movicol	NE	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	APOHEALTH Macrogol with Electrolytes	GX	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	APO-MACROGOL plus ELECTROLYTES	TX	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Chemists' Own Macrogol with Electrolytes	RW	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Macrovic	RF	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Molaxole	GO	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Movicol	NE	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1

Schedule 1, Part 1, entry for Meloxicam in the form Tablet 7.5 mg

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

Meloxicam Viatris

MP NP

C4907 C4962

Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

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

Blooms The Chemist Metformin 500 mg

MP NP

100

Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

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

Blooms The Chemist Metformin 850 mg

MP NP

Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

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

Blooms The Chemist Metformin 1000 mg

MP NP

Schedule 1, Part 1, after entry for Morphine in the form Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 1 mL

insert:

Oral solution containing morphine sulfate 2 mg per mL in 100 mL bottle, 1 mL (S19A)	Oral	Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL)	DZ	MP NP	C10764 C10770 C10777 C11697	P10764 P10770 P10777	200	0	100
PDP	C10859	200	0	100
MP NP	C10764 C10770 C10777 C11697	P11697	1000	1	100
Oral solution containing morphine sulfate 2 mg per mL in 500 mL bottle, 1 mL (S19A)	Oral	Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL)	DZ	MP NP	C10764 C10770 C10777 C11697	P10764 P10770 P10777	200	0	500
PDP	C10859	200	0	500
MP NP	C10764 C10770 C10777 C11697	P11697	2000	1	500

Schedule 1, Part 1, after entry for Morphine in the form Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 1 mL

insert:

Oral solution containing morphine sulfate 10 mg per 5 mL in 100 mL bottle, 1 mL (S19A)	Oral	Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL	LM	MP NP	C10764 C10770 C10777 C11697	P10764 P10770 P10777	200	0	100
PDP	C10859	200	0	100
MP NP	C10764 C10770 C10777 C11697	P11697	1000	1	100
Oral solution containing morphine sulfate 10 mg per 5 mL in 300 mL bottle, 1 mL (S19A)	Oral	Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL	LM	MP NP	C10764 C10770 C10777 C11697	P10764 P10770 P10777	200	0	300
PDP	C10859	200	0	300
MP NP	C10764 C10770 C10777 C11697	P11697	2100	1	300

Schedule 1, Part 1, entry for Moxonidine in the form Tablet 400 micrograms

(a)omit:

Moxonidine MYL

MP NP

C4944 C14289

P4944

(b)omit:

Moxonidine MYL

MP NP

C4944 C14289

P14289

Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid

substitute:

Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	a	MYCOTEX	CR	MP	120	5	120
a	Myfortic	NV	MP	120	5	120
a	MYCOTEX	CR	MP	P4084 P4095 P9692 P9809	240 CN4084 CN4095 CN9692 CN9809	5 CN4084 CN4095 CN9692 CN9809	120	C(100)
a	Myfortic	NV	MP	P4084 P4095 P9692 P9809	240 CN4084 CN4095 CN9692 CN9809	5 CN4084 CN4095 CN9692 CN9809	120	C(100)

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

(a)insert in the column headed “Schedule Equivalent” for the brand “Nevirapine Alphapharm”: a

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

Nevirapine Viatris

MP NP

C4454 C4512

120

D(100)

Schedule 1, Part 1, entry for Nicorandil in each of the forms: Tablets 10 mg, 60; and Tablets 20 mg, 60

(a)omit:

Ikorel

MP NP

(b)omit:

Ikorel

MP NP

P14238

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”: C13888

(b)insert in numerical order in the column headed “Circumstances”: C14676

Schedule 1, Part 1, entry for Octreotide in the form Injection 500 micrograms (as acetate) in 1 mL

omit:

Octreotide MaxRx

C6369 C6390 C8165 C9232 C9233 C9289

D(100)

Schedule 1, Part 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

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

Zypine ODT

MP NP

C5856 C5869

Schedule 1, Part 1, entry for Olanzapine in each of the forms: Tablet 10 mg (orally disintegrating); Tablet 15 mg (orally disintegrating); and Tablet 20 mg (orally disintegrating)

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

Zypine ODT

MP NP

C5856 C5869

Schedule 1, Part 1, entry for Olanzapine in each of the forms: Wafer 5 mg; Wafer 10 mg; Wafer 15 mg; and Wafer 20 mg

omit:

Zypine ODT

MP NP

C5856 C5869

Schedule 1, Part 1, entry for Olmesartan in the form Tablet containing olmesartan medoxomil 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”:

Blooms The Chemist Olmesartan

MP NP

Schedule 1, Part 1, entry for Olmesartan in the form Tablet containing olmesartan medoxomil 20 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Blooms The Chemist Olmesartan

MP NP

P14238

Schedule 1, Part 1, entry for Olmesartan in the form Tablet containing olmesartan medoxomil 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”:

Blooms The Chemist Olmesartan

MP NP

Schedule 1, Part 1, entry for Olmesartan in the form Tablet containing olmesartan medoxomil 40 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Schedule 4, Part 1, entry for Upadacitinib

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C11976”: P11976

(b)omit:

C12090	P12090	Ankylosing spondylitis Initial treatment - Initial 1 (new patient) The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total 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. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks 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 reason this criterion cannot be satisfied. 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) which includes the following: (i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within these timeframes, 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 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.	Compliance with Written Authority Required procedures
C12091	P12091	Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior 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 be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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) which includes the following: (i) details of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a BASDAI score. 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 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 a response assessment is not conducted within these timeframes, 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 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.	Compliance with Written Authority Required procedures
C12142	P12142	Ankylosing spondylitis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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 is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. All measurements provided must be no more than 4 weeks old at the time of application. 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 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 a response assessment is not conducted within these timeframes, 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 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 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

(c)insert after entry for Circumstances Code “C11978”:

C12174

P12174

Ankylosing spondylitis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

(d)omit:

C12184	P12184	Ankylosing spondylitis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.	Compliance with Authority Required procedures
C12246	P12246	Ankylosing spondylitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) 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 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. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for 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. 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 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. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications. All measurements provided must be no more than 4 weeks old at the time of application. 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 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

(e)insert in the column headed “Purposes Code” for the Circumstances Code “C13990”: P13990

(f)insert in the column headed “Purposes Code” for the Circumstances Code “C13999”: P13999

(g)insert in the column headed “Purposes Code” for the Circumstances Code “C14014”: P14014

(h)insert in numerical order after existing text:

C14653	P14653	Severe Crohn disease Balance of supply for Initial (induction) treatment phases 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)]. The treatment must have been prescribed in a quantity in the most recent prescription which did not seek the full quantity available in regards to any of: (i) the quantity per dispensing, (ii) repeat prescriptions; AND The treatment must provide no more than the balance available under the treatment phase from which the immediately preceding supply was obtained under.	Compliance with Authority Required procedures
C14655	P14655	Ankylosing spondylitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) 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/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 at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a patient is changing from PBS-subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. Where a response assessment is not conducted within these timeframes, 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 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 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
C14662	P14662	Ankylosing spondylitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR Patient must have a C-reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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 must be provided at the time of application and documented in the patient's medical records: (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a baseline ESR and/or CRP level. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within these timeframes, 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 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.	Compliance with Written Authority Required procedures
C14670	P14670	Ankylosing spondylitis Initial treatment - Initial 1 (new patient) The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks 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 reason this criterion cannot be satisfied. 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 must be provided at the time of application and documented in the patient's medical records: (i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a baseline BASDAI score; and (iii) a completed Exercise Program Self Certification Form included in the supporting information form; and (iv) baseline ESR and/or CRP level. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within these timeframes, 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 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.	Compliance with Written Authority Required procedures
C14692	P14692	Ankylosing spondylitis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be at least 18 years of age. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. 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 is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following: (a) an ESR measurement no greater than 25 mm per hour; or (b) a CRP measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline. Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment. The assessment of response to treatment must be documented in the patient's medical records. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within these timeframes, 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 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 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
C14696	P14696	Severe Crohn disease Transitioning from non-PBS to PBS-subsidised supply - 'grandfather' arrangements Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 December 2023; AND Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND Patient must have had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with this drug; OR Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine. 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 be at least 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). Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following: (a) patient must have evidence of intestinal inflammation; (b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, 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; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. All assessments, pathology tests and diagnostic imaging studies were to have been within 4 weeks leading up to commencing the non-PBS subsidised supply of this drug and should have been performed preferably whilst still on conventional treatment, but no longer than 4 weeks following the last dose of conventional treatment. Where extensive small intestinal disease affecting more than 50 cm of the small intestine applies, the CDAI must have been at least 220 prior to commencing the non-PBS subsidised supply of this drug. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details 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. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.	Compliance with Written Authority Required procedures
C14698	P14698	Severe Crohn disease Balance of supply for the Continuing (maintenance) treatment phase 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)]. The treatment must have been prescribed in a quantity in the most recent prescription which did not seek the full quantity available in regards to any of: (i) the quantity per dispensing, (ii) repeat prescriptions; AND The treatment must provide no more than the balance available under the treatment phase from which the immediately preceding supply was obtained under.	Compliance with Authority Required procedures
C14709	P14709	Severe Crohn disease Continuing (maintenance) treatment 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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient. Patient must be at least 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). In relation to the immediately preceding supply of this biological medicine, provide at least one of the following which is not more than 4 weeks from the last administered dose: (i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or (ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant.

C14710	P14710	Severe Crohn disease Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) 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 prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND Patient must have evidence of intestinal inflammation; OR Patient must be assessed clinically as being in a high faecal output state; OR Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Patient must be at least 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). Provide at least one of the following: (i) the current Crohn Disease Activity Index (CDAI) score, including the date this score was calculated on; (ii) confirmation that there is a documented history of intestinal inflammation plus diagnostic imaging/surgical evidence of at least one of: (a) short gut syndrome, (b) ileostomy, (c) colostomy; (iii) confirmation that there is a documented history and radiological evidence of intestinal inflammation from extensive small intestinal disease affecting more than 50 cm of the small intestine where the CDAI score is at least 220, but below 300. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, 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; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.	Compliance with Written Authority Required procedures
C14711	P14711	Severe Crohn disease Extended induction period (optional) from weeks 12 to 24 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 experienced an inadequate therapeutic benefit following at least one of: (i) dosing with 45 mg daily in the initial 12-week induction period, (ii) dosing with 15 mg daily. Patient must be at least 18 years of age.	Compliance with Authority Required procedures
C14721	P14721	Severe Crohn disease Initial 1 (induction treatment covering the first 12 weeks in a patient untreated with biological medicine) 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 be at least 18 years of age. Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. 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). Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following: (a) patient must have evidence of intestinal inflammation; (b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. Evidence of intestinal inflammation includes: (i) blood: higher than normal platelet count, or, 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; or (ii) faeces: higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details 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. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.	Compliance with Written Authority Required procedures
C14728	P14728	Severe Crohn disease Continuing (maintenance) treatment 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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; OR The condition must have not met the improvements specified above due to the prescribed dose being too low - this authority application seeks higher dosing. Patient must be at least 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). In relation to the immediately preceding supply of this biological medicine, provide at least one of the following which is not more than 4 weeks from the last administered dose: (i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or (ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant.	Compliance with Written Authority Required procedures
C14734	P14734	Severe Crohn disease Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) 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 prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND The treatment must not have on a previous occasion failed to provide the patient with an adequate response during the current treatment cycle. Patient must be at least 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). In relation to the biological medicine prescribed immediately before this one, provide at least one of the following which is not more than 4 weeks from the last administered dose: (i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or (ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; or (iii) confirmation that a severe intolerance occurred that resulted in the cessation of treatment.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Zoledronic acid

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C5605”: P5605

(b)insert in the column headed “Purposes Code” for the Circumstances Code “C5703”: P5703

(c)insert in the column headed “Purposes Code” for the Circumstances Code “C5704”: P5704

(d)insert in the column headed “Purposes Code” for the Circumstances Code “C5735”: P5735

(e)insert in the column headed “Purposes Code” for the Circumstances Code “C9268”: P9268

(f)insert in the column headed “Purposes Code” for the Circumstances Code “C9304”: P9304

(g)insert in the column headed “Purposes Code” for the Circumstances Code “C9317”: P9317

(h)insert in the column headed “Purposes Code” for the Circumstances Code “C9328”: P9328

(i)insert in numerical order after existing text:

C14729	P14729	Adjuvant management of breast cancer Patient must be post-menopausal. Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.	Compliance with Authority Required procedures - Streamlined Authority Code 14729
C14735	P14735	Adjuvant management of breast cancer Patient must be post-menopausal. Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.	Compliance with Authority Required procedures - Streamlined Authority Code 14735

Schedule 5, after entry for Adalimumab

insert:

Adefovir	GRP-28116	Tablet containing adefovir dipivoxil 10 mg	Oral	APO-Adefovir
Tablet containing adefovir dipivoxil 10 mg (S19A)	Oral	Adefovir Dipivoxil Tablets 10 mg (SigmaPharm Laboratories)

Schedule 5, omit entry for Amoxicillin

Schedule 5, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [GRP-26768]

insert in alphabetical order in the column headed “Brand”: Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125

Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

insert in alphabetical order in the column headed “Brand”: Blooms Clopidogrel

Schedule 5, entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single-use pre-filled syringe [GRP-23379]

omit from the column headed “Brand”: Neupogen

Schedule 5, entry for Filgrastim Injection in the form Injection 480 micrograms in 0.5 mL single-use pre-filled syringe [GRP-23385]

omit from the column headed “Brand”: Neupogen

Schedule 5, entry for Imatinib in the form Capsule 100 mg (as mesilate) [GRP-21074]

omit from the column headed “Brand”: CIPLA IMATINIB ADULT

Schedule 5, entry for Imatinib

omit:

GRP-25645	Capsule 100 mg (as mesilate)	Oral	IMATINIB-DRLA Imatinib-APOTEX
Tablet 100 mg (as mesilate)	Oral	Gilmat Glivec IMATINIB RBX Imatinib-Teva

Schedule 5, entry for Imatinib in the form Capsule 400 mg (as mesilate) [GRP-21079]

omit from the column headed “Brand”: CIPLA IMATINIB ADULT

Schedule 5, entry for Imatinib

omit:

GRP-25647	Capsule 400 mg (as mesilate)	Oral	Imatinib-APOTEX IMATINIB-DRLA Imatinib GH
Tablet 400 mg (as mesilate)	Oral	Gilmat Glivec IMATINIB RBX Imatinib-Teva

Schedule 5, entry for Meloxicam in the form Tablet 7.5 mg [GRP-15658]

insert in alphabetical order in the column headed “Brand”: Meloxicam Viatris

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

insert:

GRP-28109	Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 1 mL	Oral	Ordine 2
Oral solution containing morphine sulfate 2 mg per mL in 100 mL bottle, 1 mL (S19A)	Oral	Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL)
Oral solution containing morphine sulfate 2 mg per mL in 500 mL bottle, 1 mL (S19A)	Oral	Morphine Sulfate (Hikma) 10 mg/5 mL (2 mg/mL)
Oral solution containing morphine sulfate 10 mg per 5 mL in 100 mL bottle, 1 mL (S19A)	Oral	Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL
Oral solution containing morphine sulfate 10 mg per 5 mL in 300 mL bottle, 1 mL (S19A)	Oral	Morphine Oral Solution (Martindale Pharma) 10 mg/5 mL

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

insert in alphabetical order in the column headed “Brand”: Zypine ODT

Schedule 5, entry for Olanzapine in the form Wafer 20 mg [GRP-15643]

omit from the column headed “Brand”: Zypine ODT

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

insert in alphabetical order in the column headed “Brand”: Zypine ODT

Schedule 5, entry for Olanzapine in the form Wafer 10 mg [GRP-15723]

omit from the column headed “Brand”: Zypine ODT

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

insert in alphabetical order in the column headed “Brand”: Zypine ODT

Schedule 5, entry for Olanzapine in the form Wafer 5 mg [GRP-15797]

omit from the column headed “Brand”: Zypine ODT

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

insert in alphabetical order in the column headed “Brand”: Zypine ODT

Schedule 5, entry for Olanzapine in the form Wafer 15 mg [GRP-15953]

omit from the column headed “Brand”: Zypine ODT

Schedule 5, entry for Ondansetron

omit:

GRP-17042	Tablet (orally disintegrating) 8 mg	Oral	APO-Ondansetron ODT APX-Ondansetron ODT Ondansetron AN ODT Ondansetron Mylan ODT Ondansetron ODT-DRLA Ondansetron SZ ODT Zotren ODT
Wafer 8 mg	Oral	Zofran Zydis

Schedule 5, omit entry for Pancrelipase

Schedule 5, omit entry for Pyridostigmine