National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 12) (Cth)

PB 111 of 2022

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 12)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), 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 2022

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

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 2022 (No. 12).

(2)This Instrument may also be cited as PB 111 of 2022.

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 2022	1 December 2022

Note: This table relates only to the provisions of this instrument as originally made.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

substitute:

Abatacept	Injection 125 mg in 1 mL single dose autoinjector	Injection	Orencia ClickJect	BQ	MP	C8627 C8638 C8655 C8746 C11776 C11805	P8638 P8746 P11776 P11805	4	3	4
MP	C8627 C8638 C8655 C8746 C11776 C11805	P8627 P8655	4	5	4
Injection 125 mg in 1 mL single dose pre‑filled syringe	Injection	Orencia	BQ	MP	C8627 C8638 C8655 C8746 C11776 C11805	P8638 P8746 P11776 P11805	4	3	4
MP	C8627 C8638 C8655 C8746 C11776 C11805	P8627 P8655	4	5	4
Powder for I.V. infusion 250 mg	Injection	Orencia	BQ	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	PB(100)

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
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	C11526 C12116	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)
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P12273	4	2	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P12272 P12315	4	5	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	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)
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	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	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P12273	4	2	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P12273	4	2	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P12273	4	2	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P12273	4	2	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11529 P12272 P12315	4	5	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11529 P12272 P12315	4	5	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11529 P12272 P12315	4	5	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11529 P12272 P12315	4	5	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	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	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11713	2	0	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2

Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694	2	3	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11107 P12155 P12212 P13556 P13607 P13612 P13683	2	4	2
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240	2	5	2
MP	C11526 C12116	2	5	2	C(100)
Amgevita	XT	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Hadlima	RF	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Hyrimoz	SZ	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Idacio	PK	MP	C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694	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 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	P12103 P12105 P12153 P12155 P12161 P12212	1	0	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	P12273	2	2	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	P12306	2	5	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	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 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	P12103 P12105 P12153 P12155 P12161 P12212	1	0	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	P12273	2	2	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	P12306	2	5	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306	P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278	3	0	1

Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine

omit:

Oral liquid 130 mL, 30 (PKU Air 15)

Oral

PKU Air 15

MP NP

C4295

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

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

BTC Amlodipine

MP NP

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

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

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

insert:

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	1	1

Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

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

a	APO-AMOXY/CLAV 500/125	TW	MP NP	C5832 C5893 C10405	P5832 P5893	10	0	10
MW	C5832 C5893	10	0	10
PDP	C5833 C5894	10	0	10

Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 20; Number of Repeats: 0]

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

APO-AMOXY/CLAV 500/125

MP NP

C5832 C5893 C10405

P10405

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”:

a	APO-AMOXY/CLAV 875/125	TW	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”:

APO-AMOXY/CLAV 875/125

MP NP

C5832 C5893 C10413

P10413

Schedule 1, Part 1, after entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

insert:

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A)	Oral	a	Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg	DZ	MP NP	C5832 C5893 C10413	P5832 P5893	10	0	20
PDP	C5833 C5894	10	0	20
MP NP	C5832 C5893 C10413	P10413	20	0	20

Schedule 1, Part 1, entry for Ampicillin

omit:

Powder for injection 1 g (as sodium)	Injection	a	Ampicyn	AF	PDP	5	0	5
MP NP	5	1	5

Schedule 1, Part 1, entry for Apraclonidine

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

Schedule 1, Part 1, entry for Baricitinib

substitute:

Baricitinib	Tablet 2 mg	Oral	Olumiant	LY	MP	C8638 C8725 C8750 C11488 C11689 C11807	P8638 P8750 P11689 P11807	28	3	28
MP	C8638 C8725 C8750 C11488 C11689 C11807	P8725 P11488	28	5	3
Tablet 4 mg	Oral	Olumiant	LY	MP	C8638 C8725 C8750 C11488 C11689 C11807	P8638 P8750 P11689 P11807	28	3	28
MP	C8638 C8725 C8750 C11488 C11689 C11807	P8725 P11488	28	5	28

Schedule 1, Part 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL

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

Abevmy

See Note 3

D(100)

Schedule 1, Part 1, entry for Cefazolin

substitute:

Cefazolin	Powder for injection 500 mg (as sodium)	Injection	Cefazolin‑AFT	AE	MP NP	C5826 C5867 C5881 C5890	10	0	5
Powder for injection 1 g (as sodium)	Injection	Cefazolin‑AFT	AE	MP NP	C5861 C5882 C5883 C5891	10	0	5
Powder for injection 2 g (as sodium)	Injection	a	Cefazolin-AFT	AE	MP NP	C5826 C5867 C5881 C5890	10	0	5
a	Cephazolin Alphapharm	AF	MP NP	C5826 C5867 C5881 C5890	10	0	10

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	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P10459 P12392	2	0	2
MP	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P8706 P9185 P9625	2	2	2
MP	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P8627 P8679 P9063 P9105 P9430 P9431 P10431	2	5	2
MP	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P8626 P9073 P9074 P9183 P9442 P9537 P9610 P10513 P11386 P11430 P11686 P11748	6	0	2
Solution for injection 200 mg in 1mL pre-filled pen	Injection	Cimzia	UC	MP	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P10459 P12392	2	0	2
MP	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P8706 P9185 P9625	2	2	2
MP	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P8627 P8679 P9063 P9105 P9430 P9431 P10431	2	5	2
MP	C8626 C8627 C8679 C8706 C9063 C9073 C9074 C9105 C9183 C9185 C9430 C9431 C9442 C9537 C9610 C9625 C10431 C10459 C10513 C11386 C11430 C11686 C11748 C12392	P8626 P9073 P9074 P9183 P9442 P9537 P9610 P10513 P11386 P11430 P11686 P11748	6	0	2

Schedule 1, Part 1, omit entry for Dipyridamole with aspirin

Schedule 1, Part 1, omit entry for Doxepin

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

omit from the column headed “Circumstances” for the brand “APX-Escitalopram”: C4755 substitute: C4690 C4703 C4755 C4756 C4757

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 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P8638 P8760 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707	2	3	1
MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	2	5	1
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)
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P8638 P8760 P9064 P9410 P9429 P11107 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707	1	3	1
Enbrel	PF	MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P8638 P8760 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707	1	3	1
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P7276 P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P8887 P8955 P9081 P9123 P9140 P9156 P9162 P9481 P9487 P9502 P9554	1	5	1
Enbrel	PF	MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	1	5	1
Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P8638 P8760 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707	1	3	1
MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	1	5	1
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)
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P8638 P8760 P9064 P9410 P9429 P11107 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707	1	3	1
Enbrel	PF	MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P8638 P8760 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707	1	3	1
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P7276 P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P8887 P8955 P9081 P9123 P9140 P9156 P9162 P9481 P9487 P9502 P9554	1	5	1
Enbrel	PF	MP	C7289 C8638 C8662 C8692 C8718 C8760 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	1	5	1

Schedule 1, Part 1, entry for Evolocumab

substitute:

Evolocumab	Injection 140 mg in 1 mL single use pre-filled pen	Injection	Repatha	AN	MP	C10388 C12010 C12011 C13467 C13469 C13563 C13564 C13664	P12010 P12011 P13467 P13563 P13564 P13664	2	5	1
MP	C10388 C12010 C12011 C13467 C13469 C13563 C13564 C13664	P10388 P13469	3	5	1
Injection 420 mg in 3.5 mL single use pre-filled cartridge	Injection	Repatha	AN	MP	C10388 C12010 C12011 C13467 C13469 C13563 C13564 C13664	1	5	1

Schedule 1, Part 1, entry for Fingolimod in the form Capsule 500 micrograms (as hydrochloride)

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

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

Pharmacor Fingolimod

C10162 C10172

Schedule 1, Part 1, entry for Fluconazole

omit:

Solution for I.V. infusion 200 mg in 100 mL	Injection	Fluconazole Alphapharm	AF	MP NP	C6956 C6965 C6969 C6974 C6978 C7897	7	0	1
Solution for I.V. infusion 400 mg in 200 mL	Injection	Fluconazole Alphapharm	AF	MP NP	C5978 C5989 C6002 C6023 C6030 C7898	1	0	1

Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 3]

omit from the column headed “Circumstances”: C12401 C12468

Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C12401 C12468

(b)omit from the column headed “Purposes”: P12401 P12468

Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]

omit from the column headed “Circumstances”: C12401 C12468

Schedule 1, Part 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C12401 C12468

(b)omit from the column headed “Purposes”: P12401 P12468

Schedule 1, Part 1, entry for Heparin

omit:

Injection (preservative-free) 5,000 I.U. (as sodium) in 5 mL

Injection

Pfizer Australia Pty Ltd

MP NP

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)
Solution for injection 120 mg in 1 mL pre-filled pen	Injection	Remsima SC	EW	MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P13104	1	0	1
MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P13040 P13058 P13061 P13068 P13094 P13096	2	0	1
MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P13039 P13045 P13069 P13077 P13078 P13080 P13097	2	2	1
MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P11826 P11828 P11910 P13043 P13056 P13079 P13095	2	5	1
Solution for injection 120 mg in 1 mL pre-filled syringe	Injection	Remsima SC	EW	MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P13104	1	0	1
MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P13040 P13058 P13061 P13068 P13094 P13096	2	0	1
MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P13039 P13045 P13069 P13077 P13078 P13080 P13097	2	2	1
MP	C11826 C11828 C11910 C13039 C13040 C13043 C13045 C13056 C13058 C13061 C13068 C13069 C13077 C13078 C13079 C13080 C13094 C13095 C13096 C13097 C13104	P11826 P11828 P11910 P13043 P13056 P13079 P13095	2	5	1

Schedule 1, Part 1, entry for Interferon beta-1a

omit:

Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose autoinjector	Injection	Rebif 44	SG	MP	C6860 C7695	12	5	12
Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe	Injection	Rebif 44	SG	MP	C6860 C7695	12	5	12
Solution for injection 132 micrograms in 1.5 mL multidose cartridge	Injection	Rebif 44	SG	MP	C6860 C7695	4	5	4

Schedule 1, Part 1, entry for Ketoconazole in the form Shampoo 20 mg per g, 60 mL

omit from the column headed “Responsible Person”: JT substitute: KY

Schedule 1, Part 1, entry for Labetalol in the form Tablet containing labetalol hydrochloride 100 mg

(a)omit from the column headed “Schedule Equivalent” for the brand “Presolol 100”: a

(b)omit:

Trandate

MP NP

100

Schedule 1, Part 1, entry for Lanadelumab

omit from the column headed “Circumstances”: C12416

Schedule 1, Part 1, entry for Leuprorelin in the form I.M. injection (3 month modified release), powder for injection containing leuprorelin acetate 30 mg with diluent in pre-filled dual-chamber syringe

(a)omit from the column headed “Circumstances”: C6425

(b)insert in numerical order in the column headed “Circumstances”: C13624

Schedule 1, Part 1, entry for Leuprorelin in the form Suspension for subcutaneous injection (modified release) containing leuprorelin acetate 45 mg, injection set

insert in numerical order in the column headed “Circumstances”: C12351 C13624

Schedule 1, Part 1, entry for Lorlatinib in each of the forms: Tablet 25 mg; and Tablet 100 mg

omit from the column headed “Circumstances”: C10530 C10641 substitute: C13558 C13716

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

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

Moxonidine Viatris

MP NP

C4944

Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 150; Number of Repeats: 5]

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

Noumed Mycophenolate

150

Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 300; Number of Repeats: 5]

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

Noumed Mycophenolate

P5554 P5795 P9691 P9693

300
CN5554 CN5795 CN9691 CN9693

5
CN5554 CN5795 CN9691 CN9693

C(100)

Schedule 1, Part 1, entry for Natalizumab

omit from the column headed “Circumstances”: C9744 C9818 substitute: C13625 C13718

Schedule 1, Part 1, entry for Nitrofurantoin

substitute:

Nitrofurantoin	Capsule 50 mg	Oral	a	APO-Nitrofurantoin	TX	MP NP MW	30	1	30
a	ARX-Nitrofurantoin	XT	MP NP MW	30	1	30
a	Nitrofurantoin BNM	BZ	MP NP MW	30	1	30
Capsule 100 mg	Oral	a	APO-Nitrofurantoin	TX	MP NP MW	30	1	30
a	ARX-Nitrofurantoin	XT	MP NP MW	30	1	30
a	Nitrofurantoin BNM	BZ	MP NP MW	30	1	30

Schedule 1, Part 1, after entry for Oxybutynin in the form Tablet containing oxybutynin chloride 5 mg (s19A)

insert:

Tablet containing oxybutynin hydrochloride 5 mg (s19A)

Oral

Oxybutynin hydrochloride tablets (Niche Generics Limited)

MP NP

C6241

100

Schedule 1, Part 1, after entry for Pazopanib in the form Tablet 400 mg (as hydrochloride)

insert:

Pegcetacoplan

Solution for subcutaneous infusion 1,080 mg in 20 mL

Injection

Empaveli

See Note 3

D(100)

Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C12033 C12065 C13126 C13213 C13214 C13245 C13278 C13279 C13289 C13296 C13316

(b)insert in numerical order in the column headed “Circumstances”: C13726 C13727 C13728 C13730 C13731 C13732 C13735 C13736 C13738 C13739 C13741

Schedule 1, Part 1, omit entry for Pindolol

Schedule 1, Part 1, omit entry for Prednisolone acetate

Schedule 1, Part 1, entry for Primidone

omit:

Tablet 250 mg (USP)

Oral

APO-Primidone

MP NP

200

100

Schedule 1, Part 1, entry for Rasagiline

omit:

Rasalect

MP NP

C5339

Schedule 1, Part 1, omit entry for Risedronic acid and calcium

Schedule 1, Part 1, entry for Somatropin in the form Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)

(a)omit from the column headed “Circumstances”: C11102 C11104

(b)insert in numerical order in the column headed “Circumstances”: C13516 C13637

Schedule 1, Part 1, entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

(a)omit from the column headed “Circumstances”: C11102 C11104

(b)insert in numerical order in the column headed “Circumstances”: C13516 C13637

Schedule 1, Part 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

(a)omit from the column headed “Circumstances”: C11102 C11104

(b)insert in numerical order in the column headed “Circumstances”: C13516 C13637

Schedule 1, Part 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances”: C11102 C11104

(b)insert in numerical order in the column headed “Circumstances”: C13516 C13637

Schedule 1, Part 1, entry for Temozolomide in the form Capsule 5 mg

(a)omit:

Temizole 5

(b)omit:

Temizole 5

P4897

Schedule 1, Part 1, entry for Temozolomide in each of the forms: Capsule 20 mg; Capsule 100 mg; and Capsule 140 mg

(a)omit:

Temozolomide Alphapharm

(b)omit:

Temozolomide Alphapharm

P4897

Schedule 1, Part 1, entry for Temozolomide in the form Capsule 250 mg

omit:

Temozolomide Alphapharm

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

omit from the column headed “Circumstances”: C12354 C12366

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

(a)omit from the column headed “Circumstances”: C12354 C12366

(b)omit from the column headed “Purposes”: P12354 P12366

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

omit from the column headed “Circumstances”: C12354 C12366

Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 4]

omit from the column headed “Circumstances”: C12354 C12366

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

(a)omit from the column headed “Circumstances”: C12354 C12366

(b)omit from the column headed “Purposes”: P12354 P12366

Schedule 1, Part 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)

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

a	Valganciclovir Viatris	AL	MP	C4980 C4989 C9316	120	5	60	D(100)
NP	C4980	120	5	60	D(100)

Schedule 1, Part 1, after entry for Verapamil in the form Tablet containing verapamil hydrochloride 240 mg (sustained release)

insert:

Vericiguat	Tablet 2.5 mg	Oral	Verquvo	BN	MP	C13561 C13562 C13621	28	5	28
NP	C13561	28	5	28
Tablet 5 mg	Oral	Verquvo	BN	MP	C13561 C13562 C13621	28	5	28
NP	C13561	28	5	28
Tablet 10 mg	Oral	Verquvo	BN	MP	C13561 C13562 C13621	28	5	28
NP	C13561	28	5	28

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

substitute:

Part 2—Ready‑prepared pharmaceutical benefits for supply only

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

Listed Drug

Form

Manner of Administration

Schedule Equivalent

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Pack Quantity

Determined Quantity

Section 100/ Prescriber Bag only

Abatacept

Injection 125 mg in 1 mL single dose autoinjector

Injection

Orencia ClickJect

C12378 C12385

Injection 125 mg in 1 mL single dose pre‑filled syringe

Injection

Orencia

C12378 C12385

Powder for I.V. infusion 250 mg

Injection

Orencia

See Note 3

PB(100)

Adalimumab

Injection 20 mg in 0.2 mL pre‑filled syringe

Injection

Humira

See Note 3

C(100)

Injection 20 mg in 0.4 mL pre‑filled syringe

Injection

Amgevita

See Note 3

C(100)

Injection 40 mg in 0.4 mL pre‑filled pen

Injection

Humira

See Note 3

C(100)

C12354 C12364 C12366 C12391

Injection 40 mg in 0.4 mL pre‑filled syringe

Injection

Humira

See Note 3

C(100)

C12354 C12364 C12366 C12391

Injection 40 mg in 0.8 mL pre‑filled pen

Injection

Amgevita

See Note 3

C(100)

Hadlima

See Note 3

C(100)

Hyrimoz

See Note 3

C(100)

Idacio

See Note 3

C(100)

Amgevita

C12354 C12364 C12366 C12391

Hadlima

C12354 C12364 C12366 C12391

Hyrimoz

C12354 C12364 C12366 C12391

Idacio

C12354 C12364 C12366 C12391

Injection 40 mg in 0.8 mL pre‑filled syringe

Amgevita

See Note 3

C(100)

Hadlima

See Note 3

C(100)

Hyrimoz

See Note 3

C(100)

Idacio

See Note 3

C(100)

Amgevita

C12354 C12364 C12366 C12391

Hadlima

C12354 C12364 C12366 C12391

Hyrimoz

C12354 C12364 C12366 C12391

Idacio

C12354 C12364 C12366 C12391

Amino acid formula with vitamins and minerals without phenylalanine

Oral liquid 130 mL, 30 (PKU Air 15)

Oral

PKU Air 15

MP NP

C4295

Ampicillin

Powder for injection 1 g (as sodium)

Injection

Ampicyn

PDP

MP NP

Baricitinib

Tablet 2 mg

Oral

Olumiant

C12354 C12366

Tablet 4 mg

Oral

Olumiant

C12354 C12366

Certolizumab pegol

Injection 200 mg in 1 mL single use pre‑filled syringe

Injection

Cimzia

C12354 C12366 C12393

P12393

C12354 C12366 C12393

P12366

C12354 C12366 C12393

P12354

Solution for injection 200 mg in 1mL pre‑filled pen

Injection

Cimzia

C12354 C12366 C12393

P12393

C12354 C12366 C12393

P12366

C12354 C12366 C12393

P12354

Cromoglycic acid

Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC‑free formulation)

Inhalation by mouth

Intal CFC‑Free

MP NP

Pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC‑free formulation)

Inhalation by mouth

Intal Forte CFC‑Free

MP NP

Dipyridamole with aspirin

Capsule 200 mg (sustained release)-25 mg

Oral

Diasp SR

MP NP

C6424

Doxepin

Capsule 10 mg (as hydrochloride)

Oral

Deptran 10

MP NP

Capsule 25 mg (as hydrochloride)

Oral

Deptran 25

MP NP

Tablet 50 mg (as hydrochloride)

Oral

Deptran 50

MP NP

Etanercept

Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL

Injection

Enbrel

See Note 3

C(100)

C12354 C12359 C12366 C12389

Injection 50 mg in 1 mL single use auto-injector, 4

Injection

Enbrel

See Note 3

C(100)

Brenzys

C12354 C12366

Enbrel

C12354 C12359 C12366 C12389

Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4

Injection

Enbrel

See Note 3

C(100)

C12354 C12359 C12366 C12389

Injections 50 mg in 1 mL single use pre‑filled syringes, 4

Injection

Enbrel

See Note 3

C(100)

Brenzys

C12354 C12366

Enbrel

C12354 C12359 C12366 C12389

Glycomacropeptide and essential amino acids with vitamins and minerals

Sachets containing oral powder 51 g, 30 (PKU Bettermilk Lite)

Oral

PKU Bettermilk Lite

MP NP

C4295

Golimumab

Injection 50 mg in 0.5 mL single use pre-filled pen

Injection

Simponi

C12401 C12468

Injection 50 mg in 0.5 mL single use pre-filled syringe

Injection

Simponi

C12401 C12468

Heparin

Injection (preservative-free) 5,000 I.U. (as sodium) in 5 mL

Injection

Pfizer Australia Pty Ltd

MP NP

Infliximab

Powder for I.V. infusion 100 mg

Injection

Inflectra

See Note 3

PB(100)

Remicade

See Note 3

PB(100)

Renflexis

See Note 3

PB(100)

Solution for injection 120 mg in 1mL pre-filled pen

Injection

Remsima SC

C12363 C12378 C12390

P12363

C12363 C12378 C12390

P12390

C12363 C12378 C12390

P12378

Solution for injection 120 mg in 1mL pre-filled syringe

Injection

Remsima SC

C12363 C12378 C12390

P12363

C12363 C12378 C12390

P12390

C12363 C12378 C12390

P12378

Interferon beta-1a

Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose autoinjector

Injection

Rebif 44

C6860 C7695

Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe

Injection

Rebif 44

C6860 C7695

Solution for injection 132 micrograms in 1.5 mL multidose cartridge

Injection

Rebif 44

C6860 C7695

Ledipasvir with sofosbuvir

Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir

Oral

Harvoni

MP NP

C5944 C5969 C5972

P5944

MP NP

C5944 C5969 C5972

P5969

MP NP

C5944 C5969 C5972

P5972

Norethisterone with mestranol

Pack containing 21 tablets 1 mg-50 micrograms and 7 inert tablets

Oral

Norinyl-1/28

MP NP

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 40,000 BP units of lipase activity

Oral

Creon 40,000

MP NP

200

100

P5779

200

100

Phenelzine

Tablet 15 mg (as sulfate) (USP)

Oral

Phenelzine sulfate USP (Generic Health)

C6236

100

Pindolol

Tablet 5 mg

Oral

Barbloc 5

MP NP

100

Risedronic acid and calcium

Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)

Oral

Acris Combi

MP NP

C6306 C6319 C6325

Rituximab

Solution for I.V. infusion 100 mg in 10 mL

Injection

Ruxience

C7399 C7400 C9451 C9542

See Note 3

D(100)

Riximyo

C7399 C7400 C9451 C9542

See Note 3

D(100)

Truxima

C7399 C7400 C9451 C9542

See Note 3

D(100)

Solution for I.V. infusion 500 mg in 50 mL

Injection

Riximyo

C7399 C7400 C9451 C9542

See Note 3

D(100)

Ruxience

C7399 C7400 C9451 C9542

See Note 3

D(100)

Truxima

C7399 C7400 C9451 C9542

See Note 3

D(100)

Roxithromycin

Tablet for oral suspension 50 mg

Oral

Rulide D

PDP MP NP

Tipranavir

Capsule 250 mg

Oral

Aptivus

MP NP

C5764

240

120

D(100)

Tofacitinib

Tablet 5 mg

Oral

Xeljanz

C12354 C12366

Triglycerides, medium chain

Oral liquid 225 mL, 15 (betaquik)

Oral

Betaquik

MP NP

C6147 C6191

Upadacitinib

Tablet 15 mg

Oral

Rinvoq

C12354 C12366

Schedule 3,

omit:

Teva Pharma Australia Pty Ltd

41 169 715 664

Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C11706	P11706	Severe Crohn disease Initial treatment - Initial 1 (new patient) 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 aged 18 years or older. 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 not receive more than 16 weeks of treatment under this restriction; 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) two completed authority prescription forms; 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. Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction. 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 first or subsequent continuing treatment restrictions. 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. 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 the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition 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
C11707	P11707	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 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; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) two completed authority prescription forms; 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 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. Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction. 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 first or subsequent continuing treatment restrictions. 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. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition 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

Schedule 4, Part 1, entry for Fluconazole

omit:

C6956	Cryptococcal meningitis	Compliance with Authority Required procedures - Streamlined Authority Code 6956
C6965	Oropharyngeal candidiasis The treatment must be for prophylaxis; AND Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6965
C6969	Oesophageal candidiasis Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6969
C6974	Oropharyngeal candidiasis Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6974
C6978	Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6978
C7897	Fungal infection The condition must be serious or life-threatening.	Compliance with Authority Required procedures - Streamlined Authority Code 7897

Schedule 4, Part 1, entry for Lanadelumab

omit:

C12416

Chronic treatment of hereditary angioedema Types 1 or 2
Initial 3: Grandfather patient (commencing from non-PBS-subsidised treatment with this drug)
Patient must have previously received non-PBS-subsidised treatment with this drug as routine prophylaxis for hereditary angioedema prior to 1 December 2021; AND
Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; OR
Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab; AND
The treatment must not be used in combination with a C1-esterase inhibitor concentrate.
Must be treated by a clinical immunologist or a specialist allergist.
Patient must be aged 12 years or older.
For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate
The baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.

Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Leuprorelin

(a)omit:

C6425

Central precocious puberty
Initial treatment
Must be treated by a paediatric endocrinologist; OR
Must be treated by an endocrinologist specialising in paediatrics.
Patient must be aged 10 years or younger (girls) or 11 years or younger (boys); AND
Patient must have had onset of signs or symptoms of central precocious puberty prior to the age of 8 years (girls) or 9 years (boys).

(b)insert in numerical order after existing text:

C13624

Central precocious puberty
Initial treatment
Must be treated by a paediatric endocrinologist; OR
Must be treated by an endocrinologist specialising in paediatrics.
Patient must be of an age that is prior to their 10^thbirthday if female; OR
Patient must be of an age that is prior to their 11^thbirthday if male; AND
Patient must have had onset of signs/symptoms of central precocious puberty prior to their 8^thbirthday if female; OR
Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9^thbirthday if male.

Schedule 4, Part 1, entry for Lorlatinib

substitute:

Lorlatinib	C13558	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C13716	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.	Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Natalizumab

substitute:

Natalizumab	C13625	Clinically definite relapsing-remitting multiple sclerosis Must be treated by a neurologist. The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 13625
C13718	Clinically definite relapsing-remitting multiple sclerosis Must be treated by a neurologist. The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 13718

Schedule 4, Part 1, entry for Pembrolizumab

(a)omit:

C12033	Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Initial treatment Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease); AND Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND Patient must have a WHO performance status of 0 or 1; AND Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; AND The treatment must not exceed a total of 7 doses under this restriction.	Compliance with Authority Required procedures
C12065	Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment in a lifetime for this condition.	Compliance with Authority Required procedures
C13126	Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 7 doses under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS upload or mail, it must include: (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C13213	Relapsed or refractory primary mediastinal B-cell lymphoma Initial treatment The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan; AND Patient must be experiencing relapsed/refractory disease; AND Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR Patient must have undergone an autologous stem cell transplant (ASCT); OR Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 7 doses under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or be in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the histology results with PET/CT scans that support a diagnosis of primary mediastinal B-cell lymphoma; and (b) details of prior treatments for this condition. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C13214	Relapsed or refractory primary mediastinal B-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a total of 35 cycles in a lifetime.	Compliance with Authority Required procedures
C13245	Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a total of 35 cycles in a lifetime.	Compliance with Authority Required procedures
C13278	Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Initial treatment The condition must be incurable by local therapies in the locally advanced setting; AND Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND Patient must have had a WHO performance status of 0 or 1; AND The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND The treatment must not exceed a total of 7 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 13278
C13279	Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 doses or up to 24 months of combined initial and continuing treatment in a lifetime for this condition whichever comes first.	Compliance with Authority Required procedures - Streamlined Authority Code 13279
C13289	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 13289
C13296	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy; OR The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND Patient must have a WHO performance status of 2 or less; AND The treatment must not exceed a total of 7 doses under this restriction; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 13296
C13316	Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2022; AND Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if treated in the locally advanced setting prior to non-PBS-subsidised treatment with this drug for this condition; AND The treatment must have been initiated as non-PBS-subsidised therapy as either: (i) the sole therapy where the condition expressed programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a total of 35 doses, or up to 24 months, of combined non-PBS-subsidised and PBS-subsidised treatment under the Grandfather and Continuing treatment restrictions in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 13316

(b)insert in numerical order after existing text:

C13726	Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 13726
C13727	Relapsed or refractory primary mediastinal B-cell lymphoma Initial treatment The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan; AND Patient must have been treated with rituximab-based chemotherapy for this condition; AND Patient must be experiencing relapsed/refractory disease; AND Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR Patient must have undergone an autologous stem cell transplant (ASCT); OR Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 13727
C13728	Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Initial treatment Patient must be untreated for this PBS indication (i.e untreated for each of: (i) unresectable disease, (ii) metastatic disease); AND Patient must not have received prior treatment for colorectal cancer with each of: (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND Patient must have a WHO performance status of 0 or 1; AND Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures
C13730	Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.	Compliance with Authority Required procedures
C13731	Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 13731
C13732	Relapsed or refractory primary mediastinal B-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 13732
C13735	Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Initial treatment The condition must be incurable by local therapies in the locally advanced setting; AND Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND Patient must have had a WHO performance status of 0 or 1; AND The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 13735
C13736	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 13736
C13738	Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2022; AND Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if treated in the locally advanced setting prior to non-PBS-subsidised treatment with this drug for this condition; AND The treatment must have been initiated as non-PBS-subsidised therapy as either: (i) the sole therapy where the condition expressed programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 13738
C13739	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy; OR The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 13739
C13741	Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 13741

Schedule 4, Part 1, omit entry for Prednisolone acetate

Schedule 4, Part 1, entry for Somatropin

(a)omit:

C11102	Severe growth hormone deficiency Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child Must be treated by an endocrinologist. Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre. Patient must have a mature skeleton; OR Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form; AND Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.	Compliance with Written Authority Required procedures
C11104	Severe growth hormone deficiency Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child Must be treated by an endocrinologist. Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child. Patient must have a mature skeleton; OR Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form.	Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C13516	Severe growth hormone deficiency Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child Must be treated by an endocrinologist. Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre. Patient must have a mature skeleton; OR Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older. Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form; AND Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.	Compliance with Written Authority Required procedures
C13637	Severe growth hormone deficiency Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child Must be treated by an endocrinologist. Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child. Patient must have a mature skeleton; OR Patient must have a diagnosis of Prader-Willi syndrome and be aged 18 years or older. Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, after entry for Venlafaxine

insert:

Vericiguat	C13561	Chronic heart failure Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.	Compliance with Authority Required procedures - Streamlined Authority Code 13561
C13562	Chronic heart failure Initial treatment Must be treated by a cardiologist; OR Must be treated by a medical practitioner who has been directed to prescribe this medicine by a cardiologist. Patient must be symptomatic with NYHA classes II, III or IV; AND Patient must have a documented left ventricular ejection fraction (LVEF) of less than 45%; AND The condition must be stabilised following a decompensation event that required at least one of: (i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND Patient must not have clinical signs of fluid overload; AND Patient must not have received intravenous treatment for fluid overload in the previous 24 hours; AND Patient must not have a systolic blood pressure less than 100 mmHg; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.	Compliance with Authority Required procedures
C13621	Chronic heart failure Grandfather treatment Must be treated by a cardiologist; OR Must be treated by a medical practitioner who has been directed to prescribe this medicine by a cardiologist. Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2022; AND Patient must have been symptomatic with NYHA classes II, III or IV prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had a documented left ventricular ejection fraction (LVEF) of less than 45% prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND The condition must have been, at the time of initiating non-PBS-subsidised treatment with this drug, stabilised following a decompensation event that required at least one of: (i) hospitalisation in the 6 months prior to initiating non-PBS-subsidised drug for this PBS indication, (ii) intravenous diuretic therapy in the three months prior to initiating non-PBS-subsidised drug for this PBS indication; AND Patient must not have had clinical signs of fluid overload at the time of initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have received intravenous treatment in the 24 hours prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have a systolic blood pressure less than 100 mmHg; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; OR The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.	Compliance with Authority Required procedures

Schedule 5, omit entry for Abatacept

Schedule 5, after entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)

insert:

Amoxicillin	GRP-26767	Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL	Oral	APO-Amoxycillin Amoxil Forte Amoxycillin Sandoz Cilamox NOUMED AMOXICILLIN
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)

Schedule 5, entry for Etanercept

substitute:

Etanercept	GRP-26053	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Brenzys Enbrel
Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4	Injection	Enbrel
Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Brenzys Enbrel
GRP-26058	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Enbrel
Injection 50 mg in 1 mL single use dose-dispenser cartridges, 4	Injection	Enbrel
Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Enbrel
GRP-26183	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Brenzys
Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Brenzys

Schedule 5, omit entry for Nitrofurantoin

Schedule 5, entry for Oxybutynin

substitute:

Oxybutynin	GRP-26553	Tablet containing oxybutynin hydrochloride 5 mg	Oral	Ditropan
Tablet containing oxybutynin chloride 5 mg (s19A)	Oral	Oxybutynin Chloride (Novitium)
Tablet containing oxybutynin hydrochloride 5 mg (s19A)	Oral	Oxybutynin hydrochloride tablets (Niche Generics Limited)