National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 10) (Cth)

PB 91 of 2023

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023
(No. 10)

National Health Act 1953

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

Dated 28 September 2023

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

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

Schedule 1—Amendments 2

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

Name

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 10).

(2)This Instrument may also be cited as PB 91 of 2023.

Commencement

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

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

Note: This table relates only to the provisions of this instrument as originally made.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

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

Authority

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

4 Schedules

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

Schedule 1—Amendments

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

Schedule 1, Part 1, entry for Adalimumab

substitute:

Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11713	2	0	2
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P9715 P11715 P11716 P11761 P11852 P11854 P11855	2	3	2
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11717 P11767 P11853 P11903 P11966	2	5	2
MP	C14107 C14136	2	5	2	C(100)
Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Amgevita	XT	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11713	2	0	1
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P9715 P11715 P11716 P11761 P11852 P11854 P11855	2	3	1
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11579 P11717 P11718 P11767 P11853 P11903 P11966	2	5	1
MP	C14107 C14136	2	5	1	C(100)
Injection 40 mg in 0.4 mL pre-filled pen	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Yuflyma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11713	2	0	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11713	2	0	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	2	3	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	2	3	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	2	5	2	C(100)
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	2	5	2	C(100)
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P12273	4	2	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P12273	4	2	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P12272 P12315	4	5	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11529 P12272 P12315	4	5	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609	6	0	2
Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Yuflyma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11713	2	0	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11713	2	0	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	2	2	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	2	3	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	2	3	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	2	4	2
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	2	5	2	C(100)
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	2	5	2	C(100)
Humira	VE	MP	C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Yuflyma	EW	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P11107 P12155 P12212 P13556 P13612 P14377 P14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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	C14107 C14136	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	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 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 C13609 C13612 C13648 C13650 C13681 C13682 C13694 C14058 C14377 C14378	P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609	6	0	2
Injection 80 mg in 0.8 mL pre-filled pen	Injection	Humira	VE	MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12103 P12105 P12155 P12212 P14398 P14399	1	0	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12273	2	2	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12306	2	5	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278	3	0	1
Injection 80 mg in 0.8 mL pre-filled syringe	Injection	Humira	VE	MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12103 P12105 P12155 P12212 P14398 P14399	1	0	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12273	2	2	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P12306	2	5	1
MP	C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12155 C12212 C12229 C12273 C12275 C12278 C12306 C14398 C14399	P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278	3	0	1

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

omit:

ALENDRONATE PLUS D3 70mg/70ug APOTEX

MP NP

C6307 C6315 C6320

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

omit:

ALENDRONATE PLUS D3 70mg/140ug APOTEX

MP NP

C6306 C6319 C6325

Schedule 1, Part 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

omit from the column headed “Responsible Person”: PF substitute: IT

Schedule 1, Part 1, entry for Apomorphine in the form Solution for subcutaneous injection containing apomorphine hydrochloride 30mg in 3 mL pre-filled pen

omit from the column headed “Responsible Person” for the brand “Apomine Intermittent”: PF substitute: IT

Schedule 1, Part 1, entry for Apremilast

omit from the column headed “Circumstances” (all instances): C13243 substitute (all instances): C14417

Schedule 1, Part 1, entry for Artemether with lumefantrine in each of the forms: Tablet (dispersible) 20 mg-120 mg; and Tablet 20 mg‑120 mg

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

Schedule 1, Part 1, entry for Atenolol in the form Tablet 50 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Blooms The Chemist Atenolol

MP NP

Schedule 1, Part 1, entry for Atenolol in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Blooms The Chemist Atenolol

MP NP

P14238

Schedule 1, Part 1, entry for Azacitidine in the form Powder for injection 100 mg

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

Azacitidine Dr.Reddy's

See Note 3

PB(100)

Schedule 1, Part 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL

omit:

C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637

PB(100)

Schedule 1, Part 1, after entry for Bimatoprost with timolol in the form Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL

insert:

Bimekizumab	Injection 160 mg in 1 mL single use pre-filled pen	Injection	Bimzelx	UC	MP	C10807 C13070 C14374 C14375 C14376 C14396 C14412 C14425 C14437 C14438 C14448 C14449 C14460	P10807 P13070 P14375 P14376 P14412 P14438	2	2	2
MP	C10807 C13070 C14374 C14375 C14376 C14396 C14412 C14425 C14437 C14438 C14448 C14449 C14460	P14374 P14396 P14425 P14437 P14448 P14449 P14460	2	4	2

Schedule 1, Part 1, entry for Calcitriol

omit from the column headed “Responsible Person” for the brand “CALITROL” (all instances): ED substitute (all instances): XT

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

BTC Candesartan HCT

MP NP

C4374 C14255

P4374

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

BTC Candesartan HCT

MP NP

C4374 C14255

P14255

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

BTC Candesartan HCT

MP NP

C4374 C14255

P4374

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

BTC Candesartan HCT

MP NP

C4374 C14255

P14255

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

BTC Candesartan HCT

MP NP

C4374 C14255

P4374

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

BTC Candesartan HCT

MP NP

C4374 C14255

P14255

Schedule 1, Part 1, entry for Carfilzomib in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg

insert in numerical order in the column headed “Circumstances”: C14363 C14364 C14389

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

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

Blooms The Chemist Cefalexin

MP NP MW PDP

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

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

Blooms The Chemist Cefalexin

MP NP MW

P10410

40
CN10410

0
CN10410

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

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

Blooms The Chemist Cefalexin

P6188

40
CN6188

1
CN6188

Schedule 1, Part 1, entry for Cefuroxime

insert as first entry:

Powder for oral suspension 125 mg (as axetil) per 5 mL, 70 mL (S19A)	Oral	Zinnat (UK)	RQ	PDP	2	0	1
MP	2	1	1

Schedule 1, Part 1, after entry for Desvenlafaxine in the form Tablet (modified release) 100 mg (as benzoate)

insert:

Deucravacitinib

Tablet 6 mg

Oral

Sotyktu

C14384

Schedule 1, Part 1, entry for Dicloxacillin in the form Capsule 500 mg (as sodium) [Maximum Quantity: 24; Number of Repeats: 0]

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

a	DICLOXACILLIN VIATRIS 500	MQ	MP	C5415 C6188	P5415	24	0	24
PDP	C5268	24	0	24
NP MW	C5415	24	0	24

Schedule 1, Part 1, entry for Dicloxacillin in the form Capsule 500 mg (as sodium) [Maximum Quantity: 48; Number of Repeats: 1]

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

DICLOXACILLIN VIATRIS 500

C5415 C6188

P6188

Schedule 1, Part 1, after entry for Encorafenib in the form Capsule 75 mg

insert:

Enfortumab vedotin	Powder for I.V. infusion 20 mg	Injection	Padcev	LL	MP	C14416	See Note 3	See Note 3	1	D(100)
Powder for I.V. infusion 30 mg	Injection	Padcev	LL	MP	C14416	See Note 3	See Note 3	1	D(100)

Schedule 1, Part 1, entry for Entecavir in the form Tablet 0.5 mg (as monohydrate)

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

Entecavir Viatris

MP NP

C4993 C5036

D(100)

Schedule 1, Part 1, entry for Escitalopram in the form Tablet 10 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Lexam 10”: C4755 substitute: C4690 C4703 C4755 C4756 C4757

Schedule 1, Part 1, entry for Escitalopram in the form Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “Lexam 20”: 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 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 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P8638 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13538 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 P14382 P14427	2	3	1
MP	C7289 C8638 C8662 C8692 C8718 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 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	2	5	1
MP	C14154 C14155	2	5	1	C(100)
Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P8638 P9064 P9410 P9429 P11107 P13532 P13533 P13535 P13538 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 P14382 P14427	1	3	1
Enbrel	PF	MP	C7289 C8638 C8662 C8692 C8718 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 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P8638 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13538 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 P14382 P14427	1	3	1
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	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 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 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	1	5	1
MP	C14154 C14155	1	5	1	C(100)
Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Enbrel	PF	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P8638 P9064 P9410 P9429 P11107 P13532 P13533 P13535 P13538 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 P14382 P14427	1	3	1
Enbrel	PF	MP	C7289 C8638 C8662 C8692 C8718 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 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P8638 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13538 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 P14382 P14427	1	3	1
Brenzys	RF	MP	C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	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 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 C13538 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 C14382 C14427	P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554	1	5	1
MP	C14154 C14155	1	5	1	C(100)

Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 48 mg

omit:

Fenofibrate Mylan

MP NP

Schedule 1, Part 1, entry for Fenofibrate in the form Tablet 145 mg

omit:

Fenofibrate Mylan

MP NP

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

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

Blooms the Chemist Fluoxetine

MP NP

C4755 C6277

Schedule 1, Part 1, after entry for Fosinopril with hydrochlorothiazide

insert:

Fosnetupitant with palonosetron

Solution concentrate for I.V. infusion containing fosnetupitant 235 mg (as chloride hydrochloride) and palonosetron 250 microgram (as hydrochloride)

Injection

Akynzeo IV

MP NP

C14387

Schedule 1, Part 1, entry for Guselkumab in the form Injection 100 mg in 1 mL single use pre-filled syringe

(a)omit from the column headed “Circumstances”: C11097 C11114

(b)insert in numerical order in the column headed “Circumstances”: C14400 C14428

Schedule 1, Part 1, after entry for Insulin aspart in the form Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5

insert:

Injections (human analogue) (fast acting), cartridges, 100 units per mL, 3 mL, 5

Injection

Fiasp Penfill

MP NP

Schedule 1, Part 1, entry for Isotretinoin in the form Capsule 20 mg

(a)omit:

Isotretinoin SCP 20

C5224

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

Pharmacor Isotretinoin

C5224

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

(a)omit from the column headed “Circumstances”: C11113 C11122

(b)insert in numerical order in the column headed “Circumstances”: C14453 C14461

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

(a)omit from the column headed “Circumstances”: C11113 C11122

(b)insert in numerical order in the column headed “Circumstances”: C14453 C14461

Schedule 1, Part 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C11113 C11122

(b)insert in numerical order in the column headed “Circumstances”: C14453 C14461

(c)omit from the column headed “Purposes”: P11113 P11122

(d)insert in numerical order in the column headed “Purposes”: P14453 P14461

Schedule 1, Part 1, entry for Levonorgestrel with ethinylestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets

omit from the column headed “Responsible Person” for the brand “Eleanor 150/30 ED”: EA substitute: XT

Schedule 1, Part 1, entry for Levothyroxine in each of the forms: Tablet containing 50 micrograms anhydrous levothyroxine sodium; Tablet containing 75 micrograms anhydrous levothyroxine sodium; and Tablet containing 100 micrograms anhydrous levothyroxine sodium

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

Thyrox

MP NP

200

Schedule 1, Part 1, entry for Levothyroxine in the form Tablet containing 200 micrograms anhydrous levothyroxine sodium

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

Thyrox

MP NP

200

Schedule 1, Part 1, entry for Methotrexate in the form Tablet 2.5 mg

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

Chexate

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

Schedule 1, Part 1, entry for Methotrexate in the form Tablet 10 mg

substitute:

Tablet 10 mg	Oral	Methoblastin	PF	MP	15	3	15
a	Chexate	OX	MP	C5648	50	2	50
a	Methoblastin	PF	MP	P5648	50	2	50

Schedule 1, Part 1, entry for Methylprednisolone in the form Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g

substitute:

Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g	Application	a	Advantan (Fatty)	LO	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P4957	1	0	1
a	Tanilone (Fatty)	AS	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P4957	1	0	1
a	Advantan (Fatty)	LO	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6232	2	5	1
a	Tanilone (Fatty)	AS	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6232	2	5	1
a	Advantan (Fatty)	LO	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6246	4	5	1
a	Tanilone (Fatty)	AS	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6246	4	5	1
a	Advantan (Fatty)	LO	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6218	6	5	1
a	Tanilone (Fatty)	AS	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6218	6	5	1
a	Advantan (Fatty)	LO	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6263	8	5	1
a	Tanilone (Fatty)	AS	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6263	8	5	1
a	Advantan (Fatty)	LO	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6231	10	5	1
a	Tanilone (Fatty)	AS	MP NP	C4957 C6218 C6231 C6232 C6246 C6263	P6231	10	5	1

Schedule 1, Part 1, entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)

omit:

Methylprednisolone Alphapharm

MP NP

Schedule 1, Part 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg

omit from the column headed “Responsible Person” for the brand “Clobemix”: ED substitute: XT

Schedule 1, Part 1, entry for Moxonidine in the form Tablet 200 micrograms

(a)omit:

Moxonidine MYL

MP NP

C4944 C14289

P4944

(b)omit:

Moxonidine MYL

MP NP

C4944 C14289

P14289

Schedule 1, Part 1, entry for Netupitant with Palonosetron

omit from the column headed “Circumstances”: C5991 C5994 C6879 C6937 substitute: C14443

Schedule 1, Part 1, omit entry for Ocriplasmin

Schedule 1, Part 1, entry for Octreotide in the form Injection 50 micrograms (as acetate) in 1 mL

omit:

Octreotide MaxRx

C6369 C6390 C8165 C9232 C9233 C9289

D(100)

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

(a)omit:

Omeprazole generichealth	GQ	MP	C8774 C8775 C8776 C8780 C8866 C11310	P8774 P8775	30	1	30
NP	C8774 C8775 C8776 C8780 C8866	P8774 P8775	30	1	30

(b)omit:

Omeprazole generichealth	GQ	MP	C8774 C8775 C8776 C8780 C8866 C11310	P8776 P8780 P8866	30	5	30
NP	C8774 C8775 C8776 C8780 C8866	P8776 P8780 P8866	30	5	30

(c)omit:

Omeprazole generichealth

C8774 C8775 C8776 C8780 C8866 C11310

P11310

Schedule 1, Part 1, entry for Pembrolizumab

insert in numerical order in the column headed “Circumstances”: C14403 C14404 C14405

Schedule 1, Part 1, entry for Pirfenidone

substitute:

Pirfenidone	Tablet 267 mg	Oral	Pirfenidone Sandoz	SZ	MP	C13378 C13380 C13381	270	5	90
Tablet 801mg	Oral	Pirfenidone Sandoz	SZ	MP	C13380	90	5	90

Schedule 1, Part 1, entry for Prednisolone in the form Oral solution 5 mg (as sodium phosphate) per mL, 30 mL

substitute:

Oral solution 5 mg (as sodium phosphate) per mL, 30 mL	Oral	a	PredMix	LN	MP NP	1	5	1
a	Redipred	AS	MP NP	1	5	1

Schedule 1, Part 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)

omit:

Qpril 5

MP NP

Schedule 1, Part 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)

omit:

Qpril 10

MP NP

Schedule 1, Part 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

omit:

Qpril 20

MP NP

Schedule 1, Part 1, entry for Risankizumab

substitute:

Risankizumab	Injection 75 mg in 0.83 mL pre-filled syringe	Injection	Skyrizi	VE	MP	C6696 C9933 C9955 C10802 C10853 C11120 C11124 C11171 C14440 C14454	P6696 P9933 P9955	2	1	2
MP	C6696 C9933 C9955 C10802 C10853 C11120 C11124 C11171 C14440 C14454	P10802 P10853 P11120 P11124 P11171 P14440 P14454	2	2	2

Schedule 1, Part 1, entry for Secukinumab

substitute:

Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P11390 P12392	1	0	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P9064 P9429	1	2	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P9063 P9105 P9430 P9431 P10431	1	5	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P8831 P9064	2	2	2
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P6696 P8830 P8892 P9063 P9105	2	5	2
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P9069 P9078 P9155 P9414 P9428 P9503	4	0	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P11389 P11502 P14220	5	0	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C11089 C11096 C11138 C11154 C11389 C11390 C11502 C12392 C14220 C14430 C14462	P9069 P9078 P9155 P11089 P11096 P11138 P11154 P14430 P14462	8	0	2

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)

substitute:

Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)

Injection

Genotropin GoQuick

C12588 C12703 C12704 C12705 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12738 C12758 C12760 C12765 C12768 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12791 C12793 C12798 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12869 C12884 C12887 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364 C14366 C14390 C14431

See Note 3

D(100)

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)

substitute:

Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

Injection

Genotropin GoQuick

See Note 3

D(100)

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

substitute:

Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

Injection

Norditropin FlexPro

C12588 C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12738 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12798 C12803 C12812 C12829 C12831 C12832 C12834 C12858 C12860 C12866 C12867 C12884 C12929 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364 C14366 C14390 C14431

See Note 3

D(100)

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

substitute:

Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

Injection

NutropinAq

See Note 3

D(100)

Schedule 1, Part 1, entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-25 mg

(a)omit:

Telmisartan HCT GH 80/25

MP NP

C4374 C14255

P4374

(b)omit:

Telmisartan HCT GH 80/25

MP NP

C4374 C14255

P14255

Schedule 1, Part 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C11091

(b)omit from the column headed “Circumstances”: C11147

(c)insert in numerical order in the column headed “Circumstances”: C14464 C14465

Schedule 1, Part 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C11091

(b)omit from the column headed “Circumstances”: C11147

(c)insert in numerical order in the column headed “Circumstances”: C14464 C14465

(d)omit from the column headed “Purposes”: P11091

(e)omit from the column headed “Purposes”: P11147

(f)insert in numerical order in the column headed “Purposes”: P14464 P14465

Schedule 1, Part 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL

substitute:

Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Stelara	JC	MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11119 C11120 C11145 C11153 C11161 C12285 C12294 C12302 C12311 C12323 C12332 C12333 C12334 C12341 C14415 C14442	P12285	1	0	1
MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11119 C11120 C11145 C11153 C11161 C12285 C12294 C12302 C12311 C12323 C12332 C12333 C12334 C12341 C14415 C14442	P6696 P8891 P8987 P9063 P9116 P12302 P12311	1	1	1
MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11119 C11120 C11145 C11153 C11161 C12285 C12294 C12302 C12311 C12323 C12332 C12333 C12334 C12341 C14415 C14442	P9122 P9160 P9175 P9176 P11119 P11120 P11145 P11153 P11161 P12294 P12323 P12332 P12333 P12334 P12341 P14415 P14442	1	2	1
MP	C6696 C8891 C8987 C9063 C9116 C9122 C9160 C9175 C9176 C9655 C9656 C9657 C9710 C9711 C11119 C11120 C11145 C11153 C11161 C12285 C12294 C12302 C12311 C12323 C12332 C12333 C12334 C12341 C14415 C14442	P9655 P9656 P9657 P9710 P9711	2	0	1

Schedule 1, Part 2, entry for Fenofibrate in the form Tablet 48 mg

omit:

Fenofibrate Mylan

P7640

Schedule 1, Part 2, entry for Fenofibrate in the form Tablet 145 mg

omit:

Fenofibrate Mylan

P7640

Schedule 1, Part 2, omit entry for Insulin aspart

Schedule 1, Part 2, omit entry for Ketoconazole

Schedule 3

omit:

I-Care Pharma Distributors Pty Ltd

60 139 207 882

Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C12153

P12153

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

(b)omit:

C12161

P12161

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of 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.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

(b)omit:

C11147

P11147

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.

Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C14464	P14464	Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C14465	P14465	Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Ustekinumab

(a)omit:

C11086

P11086

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

(b)omit:

C11137

P11137

Severe chronic plaque psoriasis
Initial treatment - Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of 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.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C14415	P14415	Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of 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. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C14442	P14442	Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application: (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. 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 under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures

Schedule 5, entry for Amoxicillin with clavulanic acid

substitute:

Amoxicillin with clavulanic acid	GRP-26768	Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)	Oral	AlphaClav Duo Forte Alphaclav Duo Forte Viatris AMCLAVOX DUO FORTE 875/125 Amoxyclav AN 875/125 AmoxyClav generichealth 875/125 APO-Amoxycillin and Clavulanic Acid APO-AMOXY/CLAV 875/125 APX-Amoxicillin/Clavulanic Acid Augmentin Duo forte Curam Duo Forte 875/125
Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A)	Oral	Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge) Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo – Pro Pharmaceuticals) Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Micro Labs)

Schedule 5, entry for Omeprazole in the form Tablet 20 mg

omit from the column headed “Brand”: Omeprazole generichealth