National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 6) (Cth)

PB 60 of 2021

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 6)

National Health Act 1953

________________________________________________________________________

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

Dated 29 June 2021

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 6).

(2)This Instrument may also be cited as PB 60 of 2021.

Commencement

This Instrument commences on 1 July 2021.

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

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1 Amendments

Schedule 1, Part 1, entry for Adalimumab

substitute:

Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11713	2	0	2
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P9715 P11715 P11716 P11761 P11852 P11854 P11855	2	3	2
MP	C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11717 P11767 P11853 P11903 P11966	2	5	2
Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Amgevita	AN	MP	See Note 3	See Note 3	See Note 3	See Note 3	1	C(100)
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11713	2	0	1
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P9715 P11715 P11716 P11761 P11852 P11854 P11855	2	3	1
MP	C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966	P11579 P11717 P11718 P11767 P11853 P11903 P11966	2	5	1
MP	C11526	2	5	1	C(100)
Injection 40 mg in 0.4 mL pre-filled pen	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11538 P11545 P11551 P11552 P11560 P11572 P11587 P11594 P11609 P11618 P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6946	4	2	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6946	4	2	4
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11534 P11624	4	5	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11534 P11624	4	5	4
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6963 P9714 P9715 P10892 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11624 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6963 P9714 P9715 P10892 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	6
Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11538 P11545 P11551 P11552 P11560 P11572 P11587 P11594 P11609 P11618 P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11587 C11594 C11609 C11618 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	6
Injection 40 mg in 0.8 mL pre-filled pen	Injection	Amgevita	AN	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Hadlima	RF	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Hyrimoz	SZ	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Idacio	PK	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6946	4	2	2
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6946	4	2	2
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6946	4	2	2
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6946	4	2	2
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11529 P11534 P11624	4	5	2
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11529 P11534 P11624	4	5	2
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11529 P11534 P11624	4	5	2
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11529 P11534 P11624	4	5	2
Amgevita	AN	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6963 P9714 P9715 P10892 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Hadlima	RF	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6963 P9714 P9715 P10892 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Hyrimoz	SZ	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6963 P9714 P9715 P10892 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Idacio	PK	MP	C6696 C6946 C6963 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6963 P9714 P9715 P10892 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Amgevita	AN	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Hadlima	RF	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Hyrimoz	SZ	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Idacio	PK	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
Amgevita	AN	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Hadlima	RF	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Hyrimoz	SZ	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Idacio	PK	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11713	2	0	2
Amgevita	AN	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
Hadlima	RF	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
Hyrimoz	SZ	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2

Idacio	PK	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	2	2	2
Amgevita	AN	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Hadlima	RF	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Hyrimoz	SZ	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Idacio	PK	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P8638 P9064 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 P11861 P11866 P11972	2	3	2
Amgevita	AN	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Hadlima	RF	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Hyrimoz	SZ	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Idacio	PK	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
Amgevita	AN	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Hadlima	RF	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Hyrimoz	SZ	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Idacio	PK	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P6696 P8608 P9380 P9431 P11523 P11524 P11538 P11545 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966	2	5	2
MP	C11526	2	5	2	C(100)
Amgevita	AN	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Hadlima	RF	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Hyrimoz	SZ	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Idacio	PK	MP	C6696 C8608 C8638 C9064 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11545 C11550 C11551 C11552 C11560 C11572 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972	P9714 P9715 P11514 P11550 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855	6	0	2
Injection 80 mg in 0.8 mL pre-filled pen	Injection	Humira	VE	MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P11089 P11096 P11113 P11122 P11138 P11154	1	0	1
MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P6946	2	2	1
MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P10838	2	5	1
MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P6963 P9715 P10892 P11559 P11613 P11758 P11759 P11761 P11762 P11763 P11789 P11852 P11854 P11855	3	0	1
Injection 80 mg in 0.8 mL pre-filled syringe	Injection	Humira	VE	MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P11089 P11096 P11113 P11122 P11138 P11154	1	0	1
MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P6946	2	2	1
MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P10838	2	5	1
MP	C6946 C6963 C9715 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11559 C11613 C11758 C11759 C11761 C11762 C11763 C11789 C11852 C11854 C11855	P6963 P9715 P10892 P11559 P11613 P11758 P11759 P11761 P11762 P11763 P11789 P11852 P11854 P11855	3	0	1

Schedule 1, Part 1, entry for Alendronic acid

omit:

Alendrobell 70mg

MP NP

C6310 C6323 C6327

Schedule 1, Part 1, entry for Amisulpride in the form Tablet 100 mg

omit:

Amisulpride Sandoz

MP NP

C4246

Schedule 1, Part 1, entry for Amisulpride in each of the forms: Tablet 200 mg; and Tablet 400 mg

omit:

Amisulpride Sandoz

MP NP

C4246

Schedule 1, Part 1, entry for Amoxicillin in the form Capsule 250 mg (as trihydrate)

(a)omit:

Amoxycillin Sandoz

MP NP MW PDP

(b)omit:

Amoxycillin Sandoz

MP NP

P10404

40
CN10404

0
CN10404

Schedule 1, Part 1, entry for Anakinra

omit from the column headed “Responsible Person”: FK substitute: ZO

Schedule 1, Part 1, after entry for Cabazitaxel in the form Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent

insert:

Solution concentrate for I.V. infusion 60 mg in 6 mL

Injection

Cabazitaxel Ever Pharma

C4662

See Note 3

D(100)

Schedule 1, Part 1, entry for Cabozantinib in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8572

(b)insert in numerical order in the column headed “Circumstances”: C11880

(c)omit from the column headed “Purposes”: P8572 substitute: P11880

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

(a)omit from the column headed “Circumstances”: C8572

(b)insert in numerical order in the column headed “Circumstances”: C11880

Schedule 1, Part 1, entry for Cabozantinib in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8572

(b)insert in numerical order in the column headed “Circumstances”: C11880

(c)omit from the column headed “Purposes”: P8572 substitute: P11880

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

(a)omit from the column headed “Circumstances”: C8572

(b)insert in numerical order in the column headed “Circumstances”: C11880

Schedule 1, Part 1, entry for Cabozantinib in the form Tablet 60 mg [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8572

(b)insert in numerical order in the column headed “Circumstances”: C11880

(c)omit from the column headed “Purposes”: P8572 substitute: P11880

Schedule 1, Part 1, entry for Cabozantinib in the form Tablet 60 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8572

(b)insert in numerical order in the column headed “Circumstances”: C11880

Schedule 1, Part 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg

omit:

Candesartan GH

MP NP

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

omit:

Candesartan HCT GH 16/12.5

MP NP

C4374

Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

omit:

Candesartan HCT GH 32/12.5

MP NP

C4374

Schedule 1, Part 1, entry for Captopril

omit:

Tablet 25 mg	Oral	a	Capoten	RW	MP NP	90	5	90
a	Captopril Sandoz	SZ	MP NP	90	5	90
Tablet 50 mg	Oral	a	Capoten	RW	MP NP	90	5	90
a	Captopril Sandoz	SZ	MP NP	90	5	90

Schedule 1, Part 1, entry for Carboplatin

omit:

Solution for I.V. injection
150 mg in 15 mL

Injection

DBL Carboplatin

See Note 3

D(100)

Schedule 1, Part 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate)

(a)omit:

Cefalexin Sandoz

MP NP MW PDP

(b)omit:

Cefalexin Sandoz

MP NP MW

P10412

40
CN10412

0
CN10412

(c)omit:

Cefalexin Sandoz

P4243

40
CN4243

2
CN4243

Schedule 1, Part 1, entry for Celecoxib in the form Capsule 100 mg

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

APX-Celecoxib

MP NP

C4907 C4962

Schedule 1, Part 1, entry for Celecoxib in the form Capsule 200 mg

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

APX-Celecoxib

MP NP

C4907 C4962

Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

omit:

Androcur

P5532

20
CN5532

5
CN5532

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

omit:

Baraclude

MP NP

C4993 C5036

D(100)

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

omit:

Baraclude

MP NP

C5037 C5044

D(100)

Schedule 1, Part 1, entry for Everolimus in the form Tablet 0.25 mg

substitute:

Everolimus	Tablet 0.25 mg	Oral	a	Certican	NV	MP	60	3	60
a	Everocan	CR	MP	60	3	60
a	Certican	NV	MP	P5554 P5795 P9691 P9693	120 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)
a	Everocan	CR	MP	P5554 P5795 P9691 P9693	120 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)

Schedule 1, Part 1, entry for Everolimus in the form Tablet 0.5 mg

substitute:

Tablet 0.5 mg	Oral	a	Certican	NV	MP	60	3	60
a	Everocan	CR	MP	60	3	60
a	Certican	NV	MP	P5554 P5795 P9691 P9693	120 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)
a	Everocan	CR	MP	P5554 P5795 P9691 P9693	120 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)

Schedule 1, Part 1, entry for Everolimus in the form Tablet 0.75 mg

substitute:

Tablet 0.75 mg	Oral	a	Certican	NV	MP	120	3	60
a	Everocan	CR	MP	120	3	60
a	Certican	NV	MP	P5554 P5795 P9691 P9693	240 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)
a	Everocan	CR	MP	P5554 P5795 P9691 P9693	240 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)

Schedule 1, Part 1, entry for Everolimus in the form Tablet 1 mg

substitute:

Tablet 1 mg	Oral	a	Certican	NV	MP	120	3	60
a	Everocan	CR	MP	120	3	60
a	Certican	NV	MP	P5554 P5795 P9691 P9693	240 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)
a	Everocan	CR	MP	P5554 P5795 P9691 P9693	240 CN5554 CN5795 CN9691 CN9693	5 CN5554 CN5795 CN9691 CN9693	60	C(100)

Schedule 1, Part 1, entry for Ezetimibe with atorvastatin in the form Tablet 10 mg-10 mg

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

Ezetast

MP NP

C7958

Schedule 1, Part 1, entry for Ezetimibe with atorvastatin in each of the forms: Tablet 10 mg-20 mg; Tablet 10 mg-40 mg; and Tablet 10 mg-80 mg

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

Ezetast

MP NP

C7957

Schedule 1, Part 1, entry for Gliclazide in the form Tablet 80 mg

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

APX-Gliclazide

MP NP

100

Schedule 1, Part 1, entry for Guselkumab

insert as first entry:

Injection 100 mg in 1 mL single use pre-filled pen

Injection

Tremfya

C9172 C11890 C11917 C11918 C11919 C11979

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

(a)insert in numerical order in the column headed “Circumstances”: C9172

(b)insert in numerical order in the column headed “Circumstances”: C11890 C11917 C11918 C11919 C11979

Schedule 1, Part 1, after entry for Hydromorphone in the form Oral liquid containing hydromorphone hydrochloride 1 mg per mL, 200 mL

insert:

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 473 mL	Oral	Hydromorphone hydrochloride oral solution, USP (Medsurge)	DZ	PDP	C10859	1	0	1
MP NP	C10764 C10770 C10777 C11697	P10764 P10770 P10777	1	0	1
MP NP	C10764 C10770 C10777 C11697	P11697	1	1	1

Schedule 1, Part 1, after entry for Imipramine in the form Tablet containing imipramine hydrochloride 10 mg

insert:

Tablet containing imipramine hydrochloride 10 mg USP

Oral

Imipramine (Leading)

MP NP

100

Schedule 1, Part 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg

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

Schedule 1, Part 1, after entry for Infliximab in the form Powder for I.V. infusion 100 mg

insert:

Solution for injection 120 mg in 1 mL pre-filled pen	Injection	Remsima SC	EW	MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11869	1	0	1
MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11874 P11909	2	0	1
MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11871 P11873 P11911 P11912 P11933 P11934	2	2	1
MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11825 P11826 P11827 P11828 P11910 P11936	2	5	1
Solution for injection 120 mg in 1 mL pre-filled syringe	Injection	Remsima SC	EW	MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11869	1	0	1
MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11874 P11909	2	0	1
MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11871 P11873 P11911 P11912 P11933 P11934	2	2	1
MP	C11825 C11826 C11827 C11828 C11869 C11871 C11873 C11874 C11909 C11910 C11911 C11912 C11933 C11934 C11936	P11825 P11826 P11827 P11828 P11910 P11936	2	5	1

Schedule 1, Part 1, omit entry for Interferon alfa-2a

Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C11930

Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 150 mg-12.5 mg

omit:

Irbesartan HCT GH 150/12.5

MP NP

C4374

Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

omit:

Irbesartan HCT GH 300/12.5

MP NP

C4374

Schedule 1, Part 1, entry for Irbesartan with hydrochlorothiazide in the form Tablet 300 mg-25 mg

omit:

Irbesartan HCT GH 300/25

MP NP

C4374

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”: C9116 C9118 C9141 C9164

(b)omit from the column headed “Circumstances”: C9184 C9194

(c)insert in numerical order in the column headed “Circumstances”: C11834 C11918 C11958 C11959 C11981

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”: C9116 C9118 C9141 C9164

(b)omit from the column headed “Circumstances”: C9184 C9194

(c)insert in numerical order in the column headed “Circumstances”: C11834 C11918 C11958 C11959 C11981

(d)omit from the column headed “Purposes”: P9116 P9118 P9141 P9164

(e)omit from the column headed “Purposes”: P9184 P9194

(f)insert in numerical order in the column headed "Purposes": P11834 P11918 P11958 P11959 P11981

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”: C9116 C9118 C9141 C9164

(b)omit from the column headed “Circumstances”: C9184 C9194

(c)insert in numerical order in the column headed “Circumstances”: C11834 C11918 C11958 C11959 C11981

Schedule 1, Part 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

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

APX-Lamotrigine

MP NP

C11081

Schedule 1, Part 1, entry for Levodopa with carbidopa and entacapone in each of the forms: Tablet 50 mg-12.5 mg (as monohydrate)-200 mg; Tablet 75 mg-18.75 mg (as monohydrate)-200 mg; Tablet 100 mg-25 mg (as monohydrate)-200 mg; Tablet 125 mg-31.25 mg (as monohydrate)-
200 mg; Tablet 150 mg-37.5 mg (as monohydrate)-200 mg; and Tablet 200 mg-50 mg (as monohydrate)-200 mg

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

TRIDOPA

MP NP

C5212 C5288

200

100

Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg

omit:

Mirtazapine GH

MP NP

C5650

Schedule 1, Part 1, entry for Moclobemide in the form Tablet 150 mg

omit:

Mohexal

MP NP

C5650

Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

omit:

Montelukast GH

MP NP

C6666

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

insert in numerical order in the column headed “Circumstances”: C11985

Schedule 1, Part 1, entry for Octreotide in each of the the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; and Injection (modified release) 20 mg (as acetate), vial and diluent syringe

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

Octreotide Depot

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313

D(100)

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

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

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

Octreotide Depot

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313 C10061 C10075 C10077

D(100)

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

Schedule 1, Part 1, entry for Olmesartan in each of the forms: Tablet containing olmesartan medoxomil 20 mg; and Tablet containing olmesartan medoxomil 40 mg

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

APX-Olmesartan

MP NP

Schedule 1, Part 1, entry for Olmesartan with hydrochlorothiazide each of the forms: Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg; Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg; and Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

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

APX-Olmesartan/HCTZ

MP NP

C4374

Schedule 1, Part 1, after entry for Pancreatic extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity

insert:

Capsule (containing enteric coated minimicrospheres) providing not less than 35,000 BP units of lipase activity	Oral	Creon 35,000	GO	MP NP	200	10	100
MP	P5779	200	21	100

Schedule 1, Part 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7422 C7423

(b)omit from the column headed “Circumstances”: C9281

(c)insert in numerical order in the column headed “Circumstances”: C11937 C11939 C11974

(d)omit from the column headed “Purposes”: P7422

(e)insert in numerical order in the column headed “Purposes”: P11939

Schedule 1, Part 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7422 C7423

(b)omit from the column headed “Circumstances”: C9281

(c)insert in numerical order in the column headed “Circumstances”: C11937 C11939 C11974

(d)omit from the column headed “Purposes”: P9281

(e)insert in numerical order in the column headed “Purposes”: P11974

Schedule 1, Part 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7422 C7423

(b)omit from the column headed “Circumstances”: C9281

(c)insert in numerical order in the column headed “Circumstances”: C11937 C11939 C11974

(d)omit from the column headed “Purposes”: P7423

(e)insert in numerical order in the column headed “Purposes”: P11937

Schedule 1, Part 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7422 C7423

(b)omit from the column headed “Circumstances”: C9281

(c)insert in numerical order in the column headed “Circumstances”: C11937 C11939 C11974

(d)omit from the column headed “Purposes”: P7422

(e)insert in numerical order in the column headed “Purposes”: P11939

Schedule 1, Part 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7422 C7423

(b)omit from the column headed “Circumstances”: C9281

(c)insert in numerical order in the column headed “Circumstances”: C11937 C11939 C11974

(d)omit from the column headed “Purposes”: P9281

(e)insert in numerical order in the column headed “Purposes”: P11974

Schedule 1, Part 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7422 C7423

(b)omit from the column headed “Circumstances”: C9281

(c)insert in numerical order in the column headed “Circumstances”: C11937 C11939 C11974

(d)omit from the column headed “Purposes”: P7423

(e)insert in numerical order in the column headed “Purposes”: P11937

Schedule 1, Part 1, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

omit:

Perindopril/ Indapamide GH 4/1.25

MP NP

C4375

Schedule 1, Part 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg

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

APO-Pregabalin

MP NP

C4172

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

Blooms The Chemist Pregabalin

MP NP

C4172

Schedule 1, Part 1, entry for Progesterone in the form Capsule 200 mg

substitute:

Progesterone	Capsule 200 mg	Vaginal	Utrogestan	HB	MP	C4997	42	0	42	C(100)
MP NP MW	C11835	42	3	42

Schedule 1, Part 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel”: AP substitute: AL

Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel XR”: AP substitute: AL

Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel”: AP substitute: AL

Schedule 1, Part 1, entry for Quetiapine in each of the forms: Tablet (modified release) 150 mg (as fumarate); and Tablet (modified release)
200 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel XR”: AP substitute: AL

Schedule 1, Part 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel”: AP substitute: AL

Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel XR”: AP substitute: AL

Schedule 1, Part 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel”: AP substitute: AL

Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)

omit from the column headed “Responsible Person” for the brand “Seroquel XR”: AP substitute: AL

Schedule 1, Part 1, entry for Raloxifene

omit:

Evifyne

MP NP

C6314

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

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

APX-Rosuvastatin

MP NP

Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

APX-Rosuvastatin

P7598

Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

APX-Rosuvastatin

MP NP

Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

APX-Rosuvastatin

P7598

Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

APX-Rosuvastatin

MP NP

Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

APX-Rosuvastatin

P7598

Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

APX-Rosuvastatin

MP NP

Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

APX-Rosuvastatin

P7598

Schedule 1, Part 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)

omit from the column headed “Responsible Person” for the brand “Zempreon CFC-Free with dose counter”: GC substitute: AL

Schedule 1, Part 1, entry for Sapropterin

substitute:

Sapropterin	Powder for oral solution 500 mg (as dihydrochloride)	Oral	Kuvan	IO	MP	C8898 C8926 C10355 C10364 C10391 C11836 C11960 C11989	P8898 P10391 P11989	30	0	30
MP	C8898 C8926 C10355 C10364 C10391 C11836 C11960 C11989	P8926 P10355 P10364 P11836 P11960	30	5	30
NP	C8926 C10355 C10364 C11836 C11960	30	5	30
Tablet (soluble) containing sapropterin dihydrochloride 100 mg	Oral	Kuvan	IO	MP	C8898 C8926 C10076 C10364 C10390 C11836 C11960 C11989	P11989	30	0	30
MP	C8898 C8926 C10076 C10364 C10390 C11836 C11960 C11989	P11836 P11960	30	5	30
NP	C8926 C10364 C10390 C11836 C11960	P11836 P11960	30	5	30
MP	C8898 C8926 C10076 C10364 C10390 C11836 C11960 C11989	P8898	90	0	30
MP	C8898 C8926 C10076 C10364 C10390 C11836 C11960 C11989	P10076	180	0	30
MP	C8898 C8926 C10076 C10364 C10390 C11836 C11960 C11989	P8926 P10364 P10390	180	5	30
NP	C8926 C10364 C10390 C11836 C11960	P8926 P10364 P10390	180	5	30

Schedule 1, Part 1, entry for Simvastatin in the form Tablet 80 mg

(a)omit:

Simvastatin generichealth

MP NP

(b)omit:

Simvastatin generichealth

P7598

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P9210

(e)insert in numerical order in the column headed “Purposes”: P11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P7466 substitute: P11875

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P9210

(e)insert in numerical order in the column headed “Purposes”: P11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P7466 substitute: P11875

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P9210

(e)insert in numerical order in the column headed “Purposes”: P11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P7466 substitute: P11875

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P9210

(e)insert in numerical order in the column headed “Purposes”: P11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

(d)omit from the column headed “Purposes”: P7466 substitute: P11875

Schedule 1, Part 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C7466

(b)omit from the column headed “Circumstances”: C9210

(c)insert in numerical order in the column headed “Circumstances”: C11875 C11878

Schedule 1, Part 1, entry for Testosterone in the form Transdermal cream 50 mg per mL, 50 mL

(a)omit from the column headed “Circumstances”: C6324 C6910 C6919 C6933 C6934 substitute: C11838 C11891 C11947 C11962 C11963

(b)omit from the column headed “Number of Repeats”: 6 substitute: 1

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

(a)omit from the column headed “Circumstances”: C9069 C9116 C9141 C9155 C9157 C9170

(b)insert in numerical order in the column headed “Circumstances”: C11882 C11883 C11886 C11915 C11940 C11941 C11944 C11945 C11956 C11975 C11976 C11978

(c)omit from the column headed “Purposes”: P9069 P9155 P9157

(d)insert in numerical order in the column headed "Purposes": P11915 P11940 P11944 P11945 P11956 P11975 P11976

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

(a)omit from the column headed “Circumstances”: C9069 C9116 C9141 C9155 C9157 C9170

(b)insert in numerical order in the column headed “Circumstances”: C11882 C11883 C11886 C11915 C11940 C11941 C11944 C11945 C11956 C11975 C11976 C11978

(c)omit from the column headed “Purposes”: P9116 P9141 P9170

(d)insert in numerical order in the column headed "Purposes": P11882 P11883 P11886 P11941 P11978

Schedule 1, Part 1, after entry for Tofacitinib in the form Tablet 5 mg

insert:

Tablet 10 mg	Oral	Xeljanz	PF	MP	C11882 C11883 C11915 C11940 C11941 C11975 C11976	P11915 P11940 P11975 P11976	56	3	56
MP	C11882 C11883 C11915 C11940 C11941 C11975 C11976	P11882 P11883 P11941	56	5	56

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

(a)omit from the column headed “Circumstances”: C8680

(b)omit from the column headed “Circumstances”: C10341

(c)insert in numerical order in the column headed “Circumstances”: C11488

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

(a)omit from the column headed “Circumstances”: C8680

(b)omit from the column headed “Circumstances”: C10341

(c)insert in numerical order in the column headed “Circumstances”: C11488

(d)omit from the column headed “Purposes”: P8680 P10341

(e)insert in numerical order in the column headed "Purposes": P11488

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

substitute:

Part 2—Ready‑prepared pharmaceutical benefits for supply only

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

Listed Drug

Form

Manner of Administration

Schedule Equivalent

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Pack Quantity

Determined Quantity

Section 100/ Prescriber Bag only

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Humira

See Note 3

C(100)

C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591

P9798

C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591

P9715 P11509 P11531 P11555 P11571 P11576 P11577

C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591

P9717 P11518 P11547 P11548 P11591

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Humira

See Note 3

C(100)

C6696 C6946 C6963 C8608 C8627 C8631 C8638 C8678 C8702 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9679 C9714 C9715 C9717 C9798 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11509 C11513 C11514 C11518 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11587 C11591 C11593 C11594 C11602 C11603 C11609 C11618 C11624

P9798

P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577

P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564

P11089 P11096 P11107 P11113 P11122 P11138 P11154

P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11518 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11587 P11591 P11593 P11594 P11602 P11603 P11609 P11618

P6946

P11534 P11624

P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Humira

See Note 3

C(100)

C6696 C8608 C8627 C8631 C8638 C8678 C8702 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9679 C9714 C9715 C9717 C9798 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11509 C11513 C11514 C11518 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11587 C11591 C11593 C11594 C11602 C11603 C11609 C11618

P9798

P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577

P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564

P11089 P11096 P11107 P11113 P11122 P11138 P11154

P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11518 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11587 P11591 P11593 P11594 P11602 P11603 P11609 P11618

P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577

Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid

Oral liquid 500 mL, 20
(PKU Baby)

Oral

PKU Baby

MP NP

C4295

Amisulpride

Tablet 100 mg

Oral

Amisulpride Sandoz

MP NP

C4246

Pharmacor Amisulpride

MP NP

C4246

Tablet 200 mg

Oral

Amisulpride Sandoz

MP NP

C4246

Pharmacor Amisulpride

MP NP

C4246

Tablet 400 mg

Oral

Amisulpride Sandoz

MP NP

C4246

Pharmacor Amisulpride

MP NP

C4246

Amoxicillin

Capsule 250 mg (as trihydrate)

Oral

Amoxycillin Sandoz

MP NP MW PDP

Amoxycillin Sandoz

MP NP

P10404

40
CN10404

0
CN10404

Amoxicillin with clavulanic acid

Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

Clavam 875 mg/125 mg

MP NP

C5832 C5893 C10413

P5832 P5893

PDP

C5833 C5894

MP NP

C5832 C5893 C10413

P10413

Ampicillin

Powder for injection 1 g (as sodium)

Injection

Austrapen

PDP

MP NP

Bisacodyl

Enemas 10 mg in 5 mL, 25

Rectal

Bisalax

MP NP

C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139

P6139

Suppositories 10 mg, 10

Rectal

Dulcolax

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139

P6139

Petrus Bisacodyl Suppositories

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139

P6139

Suppositories 10 mg, 12

Rectal

Petrus Bisacodyl Suppositories

MP NP

C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139

P6139

Tablet 5 mg

Oral

Lax‑Tab

MP NP

C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139

P6139

200

Bleomycin

Powder for injection containing bleomycin sulfate 15,000 I.U. in 1 vial

Injection

Bleomycin for Injection, USP

C6224 C6275

See Note 3

D(100)

Bortezomib

Powder for injection 1 mg

Injection

Velcade

C7940 C7941 C10338 C10426 C10454 C10455

See Note 3

D(100)

Powder for injection 3 mg

Injection

Velcade

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

See Note 3

D(100)

Powder for injection
3.5 mg

Injection

Velcade

C7938 C7939 C7960 C7961 C7962 C7974

See Note 3

D(100)

Captopril

Tablet 12.5 mg

Oral

Captopril Sandoz

MP NP

Cefalexin

Capsule 250 mg (as monohydrate)

Oral

Cefalexin Sandoz

MP NP MW PDP

MP NP MW

P10412

40
CN10412

0
CN10412

P4243

40
CN4243

2
CN4243

Cefalotin

Powder for injection 1 g
(as sodium)

Injection

DBL Cephalothin

PDP

MP NP

Cimetidine

Tablet 400 mg

Oral

Magicul 400

MP NP

Clopidogrel with aspirin

Tablet 75 mg (as hydrogen sulfate)-100 mg

Oral

Clopidogrel/Aspirin Sandoz 75/100

MP NP

C5443 C5488 C5517

Cyproterone

Tablet containing cyproterone acetate 50 mg

Oral

Androcur

P5532

20
CN5532

5
CN5532

Cyprostat

P5532

20
CN5532

5
CN5532

Dalteparin

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

Injection

Fragmin

MP NP

P4910

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

Injection

Fragmin

MP NP

P4910

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

Injection

Fragmin

MP NP

P4910

MP NP

P4967

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

Injection

Fragmin

MP NP

P4910

MP NP

P4967

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

Injection

Fragmin

MP NP

P4910

MP NP

P4967

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

Injection

Fragmin

MP NP

C4967

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

Injection

Fragmin

MP NP

C4967

Darunavir

Tablet 150 mg (as ethanolate)

Oral

Prezista

C5094

240

D(100)

Diclofenac

Suppository containing diclofenac sodium 100 mg

Rectal

Voltaren 100

MP NP

P6149

Tablet (enteric coated) containing diclofenac sodium 25 mg

Oral

APO-Diclofenac

MP NP

C6149

100

Clonac 25

MP NP

C6149

100

Diclofenac Amneal

MP NP

C6149

100

Diclofenac AN

MP NP

C6149

100

Diclofenac Sandoz

MP NP

C6149

100

Fenac 25

MP NP

C6149

100

Voltaren 25

MP NP

C6149

100

Tablet (enteric coated) containing diclofenac sodium 50 mg

Oral

Pharmacor Diclofenac 50

PDP

C6256 C6282

APO-Diclofenac

MP NP

C6149

Clonac 50

MP NP

C6149

Diclofenac Amneal

MP NP

C6149

Diclofenac AN

MP NP

C6149

Diclofenac Sandoz

MP NP

C6149

Fenac

MP NP

C6149

Pharmacor Diclofenac 50

MP NP

C6149

Voltaren 50

MP NP

C6149

Donepezil

Tablet containing donepezil hydrochloride
10 mg

Oral

Pharmacor Donepezil 10

C10099 C10100 C10107 C10108 C10110

P10107 P10110

C10099 C10100 C10107 C10108 C10110

P10099 P10100 P10108

C10108

Efavirenz

Oral solution 30 mg per mL, 180 mL

Oral

Stocrin

MP NP

C4454 C4512

D(100)

Enoxaparin

Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in
0.2 mL pre-filled syringe

Injection

Clexane

MP NP

Enoxaparin Winthrop

MP NP

Clexane

MP NP

P4910

Enoxaparin Winthrop

MP NP

P4910

Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in
0.4 mL pre-filled syringe

Injection

Clexane

MP NP

Enoxaparin Winthrop

MP NP

Clexane

MP NP

P4910

Enoxaparin Winthrop

MP NP

P4910

Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in
0.6 mL pre-filled syringe

Injection

Clexane

MP NP

Enoxaparin Winthrop

MP NP

Clexane

MP NP

P4910

Enoxaparin Winthrop

MP NP

P4910

Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in
0.8 mL pre-filled syringe

Injection

Clexane

MP NP

Enoxaparin Winthrop

MP NP

Clexane

MP NP

P4910

Enoxaparin Winthrop

MP NP

P4910

Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe

Injection

Clexane

MP NP

Enoxaparin Winthrop

MP NP

Clexane

MP NP

P4910

Enoxaparin Winthrop

MP NP

P4910

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

Baraclude

MP NP

C4993 C5036

D(100)

Tablet 1 mg (as monohydrate)

Oral

Baraclude

MP NP

C5037 C5044

D(100)

Erythromycin

Tablet 400 mg (as ethyl succinate)

Oral

E-Mycin

PDP

MP NP

P6160

50 CN6160

5 CN6160

Escitalopram

Tablet 10 mg (as oxalate)

Oral

Esitalo

MP NP

C4755

Pharmacor Escitalopram 10

MP NP

C4755

Tablet 20 mg (as oxalate)

Oral

Esitalo

MP NP

C4755

Pharmacor Escitalopram 20

MP NP

C4755

Esomeprazole

Tablet (enteric coated)
20 mg (as magnesium trihydrate)

Oral

Pharmacor Esomeprazole

MP NP

C8774 C8775 C8776 C8780 C8827

P8774 P8775

MP NP

C8774 C8775 C8776 C8780 C8827

P8776 P8780 P8827

Tablet (enteric coated)
40 mg (as magnesium trihydrate)

Oral

Pharmacor Esomeprazole

MP NP

C8777 C8778 C8902

C8902

MP NP

C8777 C8778 C8902

P8777 P8778

Famciclovir

Tablet 250 mg

Oral

Famciclovir SCP 250

MP NP

C5951 C5971

P5951

MP NP

C5951 C5971

P5971

Flucloxacillin

Capsule 250 mg (as sodium)

Oral

Medsurge

PDP

C5298

MP NP MW

C5414

Capsule 500 mg (as sodium)

Oral

Medsurge

PDP

C5298

100

C5414 C6169

P5414

100

NP MW

C5414

100

C5414 C6169

P6169

100

Fluoxetine

Tablet, dispersible, 20 mg (as hydrochloride)

Oral

Prozac Tab

MP NP

C4755 C6277

Folinic acid

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

Injection

Leucovorin Calcium (Hospira Pty Limited)

Injection containing calcium folinate equivalent to 300 mg folinic acid in
30 mL

Injection

Leucovorin Calcium (Hospira Pty Limited)

Grazoprevir with elbasvir

Tablet containing grazoprevir 100 mg with elbasvir 50 mg

Oral

Zepatier

MP NP

C5969 C6625

P5969

MP NP

C5969 C6625

P6625

Indometacin

Suppository 100 mg

Rectal

Indocid

MP NP

P6149

Interferon alfa-2a

Injection 3,000,000 I.U. in
0.5 mL single dose pre-filled syringe

Injection

Roferon-A

C6632 C6648 C6672

P6648 P6672

C4993 C5036 C5042 C6661 C6662 C6678 C9259

P6662 P6678

C(100)

C6632 C6648 C6672

P6632

C4993 C5036 C5042 C6661 C6662 C6678 C9259

P6661

C(100)

C4993 C5036 C5042 C6661 C6662 C6678 C9259

P4993 P5036 P5042 P9259

C(100)

C4993 C5036

C(100)

Injection 9,000,000 I.U. in
0.5 mL single dose pre-filled syringe

Injection

Roferon-A

C6632 C6672

P6672

C4993 C5036 C5042 C6661 C6678 C9259

P6678

C(100)

C6632 C6672

P6632

C4993 C5036 C5042 C6661 C6678 C9259

P6661

C(100)

C4993 C5036 C5042 C6661 C6678 C9259

P4993 P5036 P5042 P9259

C(100)

C4993 C5036

C(100)

Ketoconazole

Shampoo 10 mg per g, 100 mL

Application

Nizoral 1%

MP NP

C6434

Labetalol

Tablet containing labetalol hydrochloride 200 mg

Oral

Presolol 200

MP NP

100

Lanreotide

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

Injection

Somatuline LA

C7042 C9225

D(100)

Lenograstim

Powder for injection 13,400,000 I.U.
(105 micrograms)

Injection

Granocyte 13

C6502 C6507 C6516 C6522 C6523 C6532 C6535 C6634 C6644 C6653 C6654 C6657 C6673 C6682 C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327

D(100)

Powder for injection 33,600,000 I.U.
(263 micrograms)

Injection

Granocyte 34

C6502 C6507 C6516 C6522 C6523 C6532 C6535 C6634 C6644 C6653 C6654 C6657 C6673 C6682 C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327

D(100)

Macrogol 3350

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

Oral

lax-sachets

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P4576 P4577 P4580 P4596 P4601

MP NP

C4576 C4577 C4580 C4596 C4601 C6171

P6171

Mesalazine

Sachet containing prolonged release granules, 1 g per sachet

Oral

Pentasa

MP NP

C9443 C9444

120

Suppository 1 g

Rectal

Pentasa

MP NP

C4878

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

Diaformin XR

MP NP

120

Metformin with glibenclamide

Tablet containing metformin hydrochloride 250 mg with glibenclamide 1.25 mg

Oral

Glucovance 250mg/1.25mg

MP NP

Tablet containing metformin hydrochloride 500 mg with glibenclamide 2.5 mg

Oral

Glucovance 500mg/2.5mg

MP NP

Tablet containing metformin hydrochloride 500 mg with glibenclamide 5 mg

Oral

Glucovance 500mg/5mg

MP NP

Methyldopa

Tablet 250 mg (as sesquihydrate)

Oral

Hydopa

MP NP

100

Moclobemide

Tablet 150 mg

Oral

Mohexal

MP NP

C5650

Nadroparin

Injection containing nadroparin calcium
(1,900 I.U. anti-Xa) in
0.2 mL pre-filled syringe

Injection

Fraxiparine

MP NP

P6014

Injection containing nadroparin calcium
(2,850 I.U. anti-Xa) in
0.3 mL pre-filled syringe

Injection

Fraxiparine

MP NP

P6014

Injection containing nadroparin calcium
(3,800 I.U. anti-Xa) in
0.4 mL pre-filled syringe

Injection

Fraxiparine

MP NP

P6014

Injection containing nadroparin calcium
(5,700 I.U. anti-Xa) in
0.6 mL pre-filled syringe

Injection

Fraxiparine

MP NP

P6014

Injection containing nadroparin calcium
(7,600 I.U. anti-Xa) in
0.8 mL pre-filled syringe

Injection

Fraxiparine

MP NP

P6014

Injection containing nadroparin calcium
(9,500 I.U. anti-Xa) in 1 mL pre-filled syringe

Injection

Fraxiparine

MP NP

P6014

Injection containing nadroparin calcium (11,400 I.U. anti-Xa) in
0.6 mL pre-filled syringe

Injection

Fraxiparine Forte

MP NP

Injection containing nadroparin calcium (15,200 I.U. anti-Xa) in
0.8 mL pre-filled syringe

Injection

Fraxiparine Forte

MP NP

Injection containing nadroparin calcium (19,000 I.U. anti-Xa) in
1 mL pre-filled syringe

Injection

Fraxiparine Forte

MP NP

Naloxone

Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule

Injection

Junalox

MP NP PDP

Naproxen

Tablet 250 mg

Oral

Inza 250

PDP

C6256 C6282

100

MP NP

C6149 C6214 C6283

100

Tablet 500 mg

Oral

Inza 500

PDP

C6256 C6282

Naprosyn

PDP

C6256 C6282

Inza 500

MP NP

C6149 C6214 C6283

Naprosyn

MP NP

C6149 C6214 C6283

Nifedipine

Tablet 20 mg (controlled release)

Oral

Adalat Oros 20mg

MP NP

Nitrazepam

Tablet 5 mg

Oral

Alodorm

MP NP PDP

MP NP

P6175

50
CN6175

3
CN6175

MP NP

P5661 P5771 P5941 P5950

50
CN5661 CN5771 CN5941 CN5950

5
CN5661 CN5771 CN5941 CN5950

Omeprazole

Tablet 20 mg

Oral

Pharmacor Omeprazole

MP NP

C8774 C8775 C8776 C8780 C8866

P8774 P8775

MP NP

C8774 C8775 C8776 C8780 C8866

P8776 P8780 P8866

Oxazepam

Tablet 15 mg

Oral

Alepam 15

MP NP PDP

MP NP

P6176

50
CN6176

3
CN6176

MP NP

P6217 P6230 P6262

50
CN6217 CN6230 CN6262

5
CN6217 CN6230 CN6262

Tablet 30 mg

Oral

Alepam 30

MP NP PDP

MP NP

P6176

50
CN6176

3
CN6176

C11882	P11882	Moderate to severe ulcerative colitis Continuing treatment or Grandfathered patients - balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug for this condition under the Continuing treatment restriction to complete 24 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Grandfathered treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.	Compliance with Authority Required procedures
C11883	P11883	Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug. Patient must be aged 18 years or older. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C11886	P11886	Severe psoriatic arthritis Continuing treatment - balance of supply Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.	Compliance with Authority Required procedures
C11915	P11915	Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion.	Compliance with Written Authority Required procedures
C11940	P11940	Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score). Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion.	Compliance with Written Authority Required procedures
C11941	P11941	Moderate to severe ulcerative colitis Initial treatment - Grandfather treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2021; AND Patient must be receiving treatment with this drug for this condition at the time of application; AND Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing non-PBS-subsidised treatment with this drug for this condition; OR Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced non-PBS-subsidised treatment with this drug for this condition where a Mayo clinic or partial Mayo clinic baseline assessment is not available; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) and current Mayo clinic or partial Mayo clinic calculation sheet, including the date of assessment; (ii) the date of commencement of this drug. The current Mayo clinic or partial Mayo clinic assessment must be no more than 4 weeks old at the time of application. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.	Compliance with Written Authority Required procedures
C11944	P11944	Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C11945	P11945	Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C11956	P11956	Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C11975	P11975	Moderate to severe ulcerative colitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score). Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion.	Compliance with Written Authority Required procedures
C11976	P11976	Moderate to severe ulcerative colitis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
C11978	P11978	Severe psoriatic arthritis Continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Upadacitinib

(a)omit:

C8680

P8680

Severe active rheumatoid arthritis
Continuing and Initial Grandfathered patients treatment - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial treatment - Grandfathered patients; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

(b)omit:

C10341

P10341

Severe active rheumatoid arthritis
Initial treatment - Grandfathered patients
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 May 2020; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) prior to initiating non-PBS-subsidised treatment with this drug for this condition. This must have included at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must have been methotrexate at a dose of at least 20 mg weekly and one of which must have been: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs prior to initiating non-PBS-subsidised treatment with this drug for this condition. If methotrexate was contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or could not be tolerated at a 20 mg weekly dose, this intensive treatment must have included at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs prior to initiating non-PBS-subsidised treatment with this drug for this condition. If 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine were contraindicated according to the relevant TGA-approved Product Information or could not be tolerated at the doses specified above, the intensive treatment must have included at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs used in place of the DMARDS which were contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to have achieved an adequate response to DMARD treatment prior to initiating non-PBS-subsidised treatment with this drug for this condition:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
All applications for treatment with this drug for this condition under this restriction must include baseline joint count and ESR and/or CRP as determined at the completion of a 6 month intensive DMARD trial but prior to ceasing DMARD therapy.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.

Compliance with Written Authority Required procedures

(c)insert after entry for Circumstances Code “C10376”:

C11488

P11488

Severe active rheumatoid arthritis
Continuing treatment - balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Patient must be aged 18 years or older.

Compliance with Authority Required procedures

Schedule 5, entry for Imipramine

insert as first entry:

GRP-25334	Tablet containing imipramine hydrochloride 10 mg	Oral	Tofranil 10
Tablet containing imipramine hydrochloride 10 mg USP	Oral	Imipramine (Leading)

Schedule 5, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg [GRP-15765]

omit from the column headed “Brand”: Perindopril/ Indapamide GH 4/1.25

Schedule 6, after entry for Golimumab in the form Injection 100 mg in 1 mL single use pre filled pen

insert:

Guselkumab

Injection 100 mg in 1 mL single use pre-filled pen

Injection

Schedule 6, after entry for Infliximab in the form Powder for I.V. infusion 100 mg

insert:

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

Schedule 6, after entry for Tofacitinib in the form Tablet 5 mg

insert:

Tofacitinib

Tablet 10 mg

Oral