National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 3) (Cth)

PB 22 of 2021

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 3)

National Health Act 1953

________________________________________________________________________

I, THEA CONNOLLY, Assistant Secretary, 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 31 March 2021

THEA CONNOLLY

Assistant Secretary

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. 3).

(2)This Instrument may also be cited as PB 22 of 2021.

Commencement

This Instrument commences on 1 April 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

Subsection 10A(3)

omit: 1 April 2021 substitute: 1 January 2022

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 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591	P9798	2	0	2
MP	C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591	P9715 P11509 P11531 P11555 P11571 P11576 P11577	2	3	2
MP	C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591	P9717 P11518 P11547 P11548 P11591	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 C9717 C9798 C11509 C11516 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11579 C11591	P9798	2	0	1
MP	C9715 C9717 C9798 C11509 C11516 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11579 C11591	P9715 P11509 P11531 P11555 P11571 P11576 P11577	2	3	1
MP	C9715 C9717 C9798 C11509 C11516 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11579 C11591	P9717 P11516 P11518 P11547 P11548 P11579 P11591	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 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	2	0	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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	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	2	5	2
MP	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	P6946	4	2	2
MP	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	P6946	4	2	4
VE	MP	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	P11534 P11624	4	5	2
VE	MP	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	P11534 P11624	4	5	4
MP	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	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
MP	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	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	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 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	2	0	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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	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	2	5	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	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	OQ	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 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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9798	2	0	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
MP	C11526	2	5	2	C(100)
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6946	4	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11529 P11534 P11624	4	5	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
Hadlima	OQ	MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9798	2	0	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
MP	C11526	2	5	2	C(100)
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6946	4	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11529 P11534 P11624	4	5	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
Hyrimoz	SZ	MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9798	2	0	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
MP	C11526	2	5	2	C(100)
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6946	4	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11529 P11534 P11624	4	5	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
Idacio	PK	MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9798	2	0	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
MP	C11526	2	5	2	C(100)
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6946	4	2	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P11529 P11534 P11624	4	5	2
MP	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 C11516 C11518 C11523 C11524 C11529 C11531 C11534 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	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	OQ	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 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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9798	2	0	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
MP	C11526	2	5	2	C(100)
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
Hadlima	OQ	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9798	2	0	2
OQ	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2

OQ	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
OQ	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
OQ	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
OQ	MP	C11526	2	5	2	C(100)
OQ	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
Hyrimoz	SZ	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9798	2	0	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
MP	C11526	2	5	2	C(100)
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
Idacio	PK	MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9798	2	0	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P6696 P8608 P8627 P9063 P9380 P9431 P9717 P11516 P11518 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11569 P11572 P11579 P11587 P11591 P11593 P11594 P11602 P11603 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635	2	5	2
MP	C11526	2	5	2	C(100)
MP	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 C11516 C11518 C11523 C11524 C11531 C11538 C11541 C11542 C11544 C11545 C11547 C11548 C11550 C11551 C11552 C11555 C11560 C11569 C11571 C11572 C11574 C11576 C11577 C11579 C11587 C11591 C11593 C11594 C11602 C11603 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
Injection 80 mg in 0.8 mL pre-filled pen	Injection	Humira	VE	MP	C6946 C6963 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P11089 P11096 P11113 P11122 P11138 P11154	1	0	1
MP	C6946 C6963 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P6946	2	2	1
MP	C6946 C6963 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P10838	2	5	1
MP	C6946 C6963 C10838 C10892 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P6963 P10892 P11558 P11559 P11595 P11613 P11615 P11622 P11623 P11636 P11638 P11640 P11641	3	0	1
Injection 80 mg in 0.8 mL pre-filled syringe	Injection	Humira	VE	MP	C6946 C10838 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P11089 P11096 P11113 P11122 P11138 P11154	1	0	1
MP	C6946 C10838 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P6946	2	2	1
MP	C6946 C10838 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P10838	2	5	1
MP	C6946 C10838 C11089 C11096 C11113 C11122 C11138 C11154 C11558 C11559 C11595 C11613 C11615 C11622 C11623 C11636 C11638 C11640 C11641	P11558 P11559 P11595 P11613 P11615 P11622 P11623 P11636 P11638 P11640 P11641	3	0	1

Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without lysine and low in tryptophan in each of the forms: Sachets containing oral powder 24 g, 30 (GA gel); and Sachets containing oral powder 25 g, 30 (GA express 15)

insert in numerical order in the column headed “Circumstances”: C11482

Schedule 1, Part 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL

substitute:

Apomorphine	Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL	Injection	Movapo	TD	MP NP	C10844	360	5	5
Apomorphine		MP	C11385 C11445	360	5	5	C(100)

Schedule 1, Part 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

substitute:

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL	Injection	Movapo	TD	MP NP	C10844	180	5	5
	MP	C11385 C11445	180	5	5	C(100)

Schedule 1, Part 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe

substitute:

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe	Injection	Movapo PFS	TD	MP NP	C10844	180	5	5
	MP	C11385 C11445	180	5	5	C(100)

Schedule 1, Part 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 3]

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

(b)omit from the column headed “Circumstances”: C8727

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

Schedule 1, Part 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 5]

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

(b)omit from the column headed “Circumstances”: C8727

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

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

(e)omit from the column headed “Purposes”: P8727

(f)insert in numerical order in the column headed “Purposes”: P11488

Schedule 1, Part 1, entry for Baricitinib in the form Tablet 4 mg [Maximum Quantity: 28; Number of Repeats: 3]

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

(b)omit from the column headed “Circumstances”: C8727

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

Schedule 1, Part 1, entry for Baricitinib in the form Tablet 4 mg [Maximum Quantity: 28; Number of Repeats: 5]

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

(b)omit from the column headed “Circumstances”: C8727

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

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

(e)omit from the column headed “Purposes”: P8727

(f)insert in numerical order in the column headed “Purposes”: P11488

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 25 mg [Maximum Quantity: 2; Number of Repeats: 0]

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

Buprenorphine Sandoz

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 25 mg [Maximum Quantity: 4; Number of Repeats: 2]

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

Buprenorphine Sandoz

MP NP

C6151 C10748 C10752 C10755

P6151

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 30 mg [Maximum Quantity: 2; Number of Repeats: 0]

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

Buprenorphine Sandoz

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 30 mg [Maximum Quantity: 4; Number of Repeats: 2]

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

Buprenorphine Sandoz

MP NP

C6151 C10748 C10752 C10755

P6151

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 40 mg [Maximum Quantity: 2; Number of Repeats: 0]

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

Buprenorphine Sandoz

MP NP

C6151 C10748 C10752 C10755

P10748 P10752 P10755

Schedule 1, Part 1, entry for Buprenorphine in the form Transdermal patch 40 mg [Maximum Quantity: 4; Number of Repeats: 2]

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

Buprenorphine Sandoz

MP NP

C6151 C10748 C10752 C10755

P6151

Schedule 1, Part 1, entry for Cabazitaxel

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

Cabazitaxel Juno

C4662

See Note 3

D(100)

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

omit:

Zedace

MP NP

Schedule 1, Part 1, entry for Cefuroxime

omit:

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

Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2;
Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 6;
Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

(d)omit from the column headed “Purposes”: P10468 P10507

(e)insert in numerical order in the column headed “Purposes”: P11386 P11430

Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 2;
Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

Schedule 1, Part 1, entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre-filled pen [Maximum Quantity: 6;
Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C10468

(b)omit from the column headed “Circumstances”: C10507

(c)insert in numerical order in the column headed “Circumstances”: C11386 C11430

(d)omit from the column headed “Purposes”: P10468 P10507

(e)insert in numerical order in the column headed “Purposes”: P11386 P11430

Schedule 1, Part 1, entry for Cinacalcet

substitute:

Cinacalcet	Tablet 30 mg (as hydrochloride)	Oral	a	Cinacalcet Mylan	AF	MP NP	C10068	28	5	28
a	Pharmacor Cinacalcet	CR	MP NP	C10068	28	5	28
a	Cinacalcet Mylan	AF	MP	C10063 C10067 C10073	56	5	28	C(100)
a	Pharmacor Cinacalcet	CR	MP	C10063 C10067 C10073	56	5	28	C(100)
Tablet 60 mg (as hydrochloride)	Oral	a	Cinacalcet Mylan	AF	MP NP	C10068	28	5	28
a	Pharmacor Cinacalcet	CR	MP NP	C10068	28	5	28
a	Cinacalcet Mylan	AF	MP	C10063 C10067 C10073	56	5	28	C(100)
a	Pharmacor Cinacalcet	CR	MP	C10063 C10067 C10073	56	5	28	C(100)
Tablet 90 mg (as hydrochloride)	Oral	a	Cinacalcet Mylan	AF	MP NP	C10068	28	5	28
a	Pharmacor Cinacalcet	CR	MP NP	C10068	28	5	28
a	Cinacalcet Mylan	AF	MP	C10063 C10067 C10073	56	5	28	C(100)
a	Pharmacor Cinacalcet	CR	MP	C10063 C10067 C10073	56	5	28	C(100)

Schedule 1, Part 1, entry for Dupilumab

substitute:

Dupilumab	Injection 200 mg in 1.14 mL single dose pre-filled syringe	Injection	Dupixent	SW	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C11374 C11377 C11425 C11443 C11479 C11480	2	5	2
Injection 300 mg in 2 mL single dose pre-filled syringe	Injection	Dupixent	SW	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
MP	C11374 C11377 C11425 C11443 C11479 C11480	2	5	2

Schedule 1, Part 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and Tablet 150 mg (as hydrochloride)

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

Erlotinib Sandoz

C4473 C4600 C7446

(b)omit:

Tarceva

C4473 C4600 C7446

Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
Number of Repeats: 1]

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

APO-Esomeprazole	TY	MP	C8774 C8775 C8776 C8780 C8827 C11310	P8774 P8775	30	1	30
NP	C8774 C8775 C8776 C8780 C8827	P8774 P8775	30	1	30

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

Esopreze	BG	MP	C8774 C8775 C8776 C8780 C8827 C11310	P8774 P8775	30	1	30
NP	C8774 C8775 C8776 C8780 C8827	P8774 P8775	30	1	30

Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]

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

APO-Esomeprazole	TY	MP	C8774 C8775 C8776 C8780 C8827 C11310	P8776 P8780 P8827	30	5	30
NP	C8774 C8775 C8776 C8780 C8827	P8776 P8780 P8827	30	5	30

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

Esopreze	BG	MP	C8774 C8775 C8776 C8780 C8827 C11310	P8776 P8780 P8827	30	5	30
NP	C8774 C8775 C8776 C8780 C8827	P8776 P8780 P8827	30	5	30

Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [Maximum Quantity: 60;
Number of Repeats: 5]

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

APO-Esomeprazole

C8774 C8775 C8776 C8780 C8827 C11310

P11310

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

Esopreze

C8774 C8775 C8776 C8780 C8827 C11310

P11310

Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
Number of Repeats: 1]

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

APO-Esomeprazole	TY	MP	C8777 C8778 C8902 C11370	P8902	30	1	30
NP	C8777 C8778 C8902	P8902	30	1	30

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

Esopreze	BG	MP	C8777 C8778 C8902 C11370	P8902	30	1	30
NP	C8777 C8778 C8902	P8902	30	1	30

Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]

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

APO-Esomeprazole	TY	MP	C8777 C8778 C8902 C11370	P8777 P8778	30	5	30
NP	C8777 C8778 C8902	P8777 P8778	30	5	30

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

Esopreze	BG	MP	C8777 C8778 C8902 C11370	P8777 P8778	30	5	30
NP	C8777 C8778 C8902	P8777 P8778	30	5	30

Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [Maximum Quantity: 60;
Number of Repeats: 5]

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

APO-Esomeprazole

C8777 C8778 C8902 C11370

P11370

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

Esopreze

C8777 C8778 C8902 C11370

P11370

Schedule 1, Part 1, entry for Fluticasone propionate

substitute:

Fluticasone propionate	Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	a	Axotide Junior	GC	MP NP	1	5	1
a		Flixotide Junior	GK	MP NP	1	5	1
Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	a	Axotide	GC	MP NP	1	5	1
	a	Flixotide	GK	MP NP	1	5	1
	a	Fluticasone Cipla Inhaler	LR	MP NP	1	5	1
Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	a	Axotide	GC	MP NP	1	1	1
	a	Flixotide	GK	MP NP	1	1	1
	a	Fluticasone Cipla Inhaler	LR	MP NP	1	1	1
Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses	Inhalation by mouth	a	Axotide Junior Accuhaler	GC	MP NP	1	5	1
	a	Flixotide Junior Accuhaler	GK	MP NP	1	5	1
Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses	Inhalation by mouth	a	Axotide Accuhaler	GC	MP NP	1	5	1
	a	Flixotide Accuhaler	GK	MP NP	1	5	1
Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms per dose, 60 doses	Inhalation by mouth	Flixotide Accuhaler	GK	MP NP	1	1	1

Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate
50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

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

PAVTIDE MDI 50/25

MP NP

C4930

(b)insert in the column headed “Schedule Equivalent” for the brand “Seretide MDI 50/25”: a

Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

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

PAVTIDE ACCUHALER 100/50

MP NP

C4930

(b)insert in the column headed “Schedule Equivalent” for the brand “Seretide Accuhaler 100/50”: a

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

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

PAVTIDE ACCUHALER 250/50

MP NP

C4930

(b)insert in the column headed “Schedule Equivalent” for the brand “Seretide Accuhaler 250/50”: a

Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

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

PAVTIDE ACCUHALER 500/50

MP NP

C4930 C10121

(b)insert in the column headed “Schedule Equivalent” for the brand “Seretide Accuhaler 500/50”: a

Schedule 1, Part 1, after entry for Framycetin

insert:

Fulvestrant

Injection 250 mg in 5 mL pre-filled syringe

Injection

Fulvestrant Sandoz

C11473

Schedule 1, Part 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg

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

APX-Gabapentin

MP NP

C4928

100

Schedule 1, Part 1, entry for Ganirelix

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

a	GANIRELIX SUN	RA	MP	C5046	10	0	1	D(100)
MP	C5046	10	0	5	D(100)

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

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

(a)omit from the column headed “Circumstances”: C10435

(b)omit from the column headed “Circumstances”: C10506

(c)insert in numerical order in the column headed “Circumstances”: C11387 C11431

(d)omit from the column headed “Purposes”: P10435

(e)omit from the column headed “Purposes”: P10506

(f)insert in numerical order in the column headed “Purposes”: P11387 P11431

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

(a)omit from the column headed “Circumstances”: C10435

(b)omit from the column headed “Circumstances”: C10506

(c)insert in numerical order in the column headed “Circumstances”: C11387 C11431

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

(a)omit from the column headed “Circumstances”: C10435

(b)omit from the column headed “Circumstances”: C10506

(c)insert in numerical order in the column headed “Circumstances”: C11387 C11431

(d)omit from the column headed “Purposes”: P10435

(e)omit from the column headed “Purposes”: P10506

(f)insert in numerical order in the column headed “Purposes”: P11387 P11431

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

(a)omit from the column headed “Circumstances”: C10435

(b)omit from the column headed “Circumstances”: C10506

(c)insert in numerical order in the column headed “Circumstances”: C11387 C11431

Schedule 1, Part 1, after entry for Indacaterol with glycopyrronium

insert:

Indacaterol with glycopyrronium and mometasone	Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 68 micrograms (for use in Breezhaler)	Inhalation by mouth	Enerzair Breezhaler	NV	MP NP	C11470	30	5	30
Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 136 micrograms (for use in Breezhaler)	Inhalation by mouth	Enerzair Breezhaler	NV	MP NP	C11470	30	5	30

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”: C11391 C11394 C11478

Schedule 1, Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

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

Irinotecan Accord

See Note 3

D(100)

Schedule 1, Part 1, omit entry for Nadroparin

Schedule 1, Part 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride)

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

Nepiten

MP NP

C5324

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

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

Nepiten

MP NP

C5324

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

(a)omit from the column headed “Circumstances”: C10117

(b)omit from the column headed “Circumstances”: C10165

(c)insert in numerical order in the column headed “Circumstances”: C11392 C11434 C11468 C11469 C11477

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

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

Maxor EC Tabs	AF	MP	C8774 C8775 C8776 C8780 C8866 C11310	P8774 P8775	30	1	30
NP	C8774 C8775 C8776 C8780 C8866	P8774 P8775	30	1	30

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

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

Maxor EC Tabs	AF	MP	C8774 C8775 C8776 C8780 C8866 C11310	P8776 P8780 P8866	30	5	30
NP	C8774 C8775 C8776 C8780 C8866	P8776 P8780 P8866	30	5	30

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

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

Maxor EC Tabs

C8774 C8775 C8776 C8780 C8866 C11310

P11310

Schedule 1, Part 1, entry for Oxycodone in the form Capsule containing oxycodone hydrochloride 5 mg

substitute:

Oxycodone	Capsule containing oxycodone hydrochloride 5 mg	Oral	OxyNorm	MF	MP NP	C10764 C10766 C10771 C10772	P10766	10	0	10
PDP	C10766 C10768	P10766	10	0	10
a	Oxycodone BNM	BZ	MP NP	C10764 C10771 C10772	20	0	20
PDP	C10768	20	0	20
a	OxyNorm	MF	MP NP	C10764 C10766 C10771 C10772	P10764 P10771 P10772	20	0	20
PDP	C10766 C10768	P10768	20	0	20

Schedule 1, Part 1, entry for Paracetamol

omit:

Suppositories 500 mg, 24

Rectal

Panadol

MP NP

C6167

Schedule 1, Part 1, entry for Phenobarbital in the form Injection 200 mg (as sodium) in 1 mL

omit from the column headed “Brand”: Fawns and McAllan Proprietary Limited substitute: Phenobarbitone Injection (Aspen Pharmacare Australia Pty Ltd)

Schedule 1, Part 1, entry for Posaconazole

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

Posaconazole ARX

MP NP

C5169 C5395 C5396

Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 21; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10018 C10037 C10038 C10044 C10054 C10057 substitute: C11458 C11459 C11471 C11498 C11499 C11500 C11506 C11507 C11508

(b)omit from the column headed “Purposes”: P10037 P10038 substitute: P11471 P11498 P11506

Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 42; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10018 C10037 C10038 C10044 C10054 C10057 substitute: C11458 C11459 C11471 C11498 C11499 C11500 C11506 C11507 C11508

(b)omit from the column headed “Purposes”: P10044 P10054 substitute: P11459 P11500 P11508

Schedule 1, Part 1, entry for Ribociclib in the form Tablet 200 mg [Maximum Quantity: 63; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C10018 C10037 C10038 C10044 C10054 C10057 substitute: C11458 C11459 C11471 C11498 C11499 C11500 C11506 C11507 C11508

(b)omit from the column headed “Purposes”: P10018 P10057 substitute: P11458 P11499 P11507

Schedule 1, Part 1, entry for Rituximab in the form Solution for I.V. infusion 100 mg in 10 mL

(a)omit:

Mabthera

See Note 3

PB(100)

(b)omit:

Mabthera

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Schedule 1, Part 1, entry for Rituximab in the form Solution for I.V. infusion 500 mg in 50 mL

(a)omit:

Mabthera

See Note 3

PB(100)

(b)omit:

Mabthera

C7399 C7400 C9451 C9542 C10227

See Note 3

PB(100)

Schedule 1, Part 1, after entry for Romiplostim in the form Powder for injection 625 micrograms

insert:

Romosozumab

Injection 105 mg in 1.17 mL single use pre-filled syringe

Injection

Evenity

C11487 C11496

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”:

Rosuvastatin Lupin

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”:

Rosuvastatin Lupin

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”:

Rosuvastatin Lupin

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”:

Rosuvastatin Lupin

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”:

Rosuvastatin Lupin

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”:

Rosuvastatin Lupin

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”:

Rosuvastatin Lupin

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”:

Rosuvastatin Lupin

P7598

Schedule 1, Part 1, entry for Secukinumab

substitute:

Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P10489 P11390	1	0	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P9064 P9429	1	2	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P9063 P9105 P9430 P9431 P10431 P11432	1	5	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P8831 P9064	2	2	2
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P6696 P8830 P8892 P9063 P9105	2	5	2
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P9069 P9078 P9155 P9414 P9428 P9503	4	0	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P11389 P11447 P11502	5	0	1
MP	C6696 C8830 C8831 C8892 C9063 C9064 C9069 C9078 C9105 C9155 C9414 C9428 C9429 C9430 C9431 C9503 C10431 C10489 C11089 C11096 C11113 C11122 C11138 C11154 C11389 C11390 C11432 C11447 C11502	P9069 P9078 P9155 P11089 P11096 P11113 P11122 P11138 P11154	8	0	2

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

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

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

insert:

Tablet 50 mg (as hydrochloride) (USP)

Oral

Sertraline tablets USP (Medsurge)

MP NP

C4755 C6277 C6289

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

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

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

insert:

Tablet 100 mg (as hydrochloride) (USP)

Oral

Sertraline tablets USP (Medsurge)

MP NP

C4755 C6277 C6289

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

omit:

Norditropin SimpleXx

C5146 C5147 C5190 C5230 C5239 C5299 C5302 C5382 C8334 C8335 C8336 C8337 C8343 C8347 C8349 C8357 C8358 C8360 C8361 C8362 C8365 C8368 C8369 C8376 C8377 C8380 C8393 C8394 C8398 C8402 C8403 C8407 C8415 C8416 C8417 C8418 C8419 C8420 C8422 C8423 C8424 C8425 C8426 C8433 C9221

See Note 3

D(100)

Schedule 1, Part 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

omit:

Norditropin SimpleXx

See Note 3

D(100)

Schedule 1, Part 1, entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)

omit:

Norditropin SimpleXx

See Note 3

D(100)

Schedule 1, Part 1, entry for Tenofovir in the form Tablet containing tenofovir disoproxil fumarate 300 mg [Maximum Quantity: 60;
Number of Repeats: 2]

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

Tenofovir Sandoz

MP NP

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P10362

D(100)

Schedule 1, Part 1, entry for Tenofovir in the form Tablet containing tenofovir disoproxil fumarate 300 mg [Maximum Quantity: 60;
Number of Repeats: 5]

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

Tenofovir Sandoz

MP NP

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P6980 P6982 P6983 P6984 P6992 P6998

D(100)

Schedule 1, Part 1, entry for Teriflunomide

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

Terimide

C10150 C10199

Schedule 1, Part 1, entry for Teriparatide

omit from the column headed “Circumstances”: C4113 C6305 substitute: C11464 C11486

Schedule 1, Part 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL

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

Zoledronic Acid SUN

C5710 C6308 C6313 C6318

Schedule 1, Part 2, omit entry for Aciclovir

Schedule 1, Part 2 after entry for Aciclovir

insert:

Adalimumab	Injection 20 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	C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591	P9798	2	0	2
MP	C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591	P9715 P11509 P11531 P11555 P11571 P11576 P11577	2	3	2
MP	C9715 C9717 C9798 C11509 C11518 C11531 C11547 C11548 C11555 C11571 C11576 C11577 C11591	P9717 P11518 P11547 P11548 P11591	2	5	2
Injection 40 mg in 0.8 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 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	2	0	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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	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	2	5	2
MP	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	P6946	4	2	2
MP	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	P11534 P11624	4	5	2
MP	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	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
MP	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	P6946	4	2	4
MP	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	P11534 P11624	4	5	4
MP	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	P6963 P9679 P9714 P9715 P10892 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	6
Injection 40 mg in 0.8 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 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	2	0	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	2	2	2
MP	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	P8631 P8638 P8678 P8702 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564	2	3	2
MP	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	P11089 P11096 P11107 P11113 P11122 P11138 P11154	2	4	2
MP	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	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	2	5	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	2
MP	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	P9679 P9714 P9715 P11509 P11513 P11514 P11531 P11544 P11550 P11555 P11571 P11574 P11576 P11577	6	0	6

Schedule 4, Part 1, after entry for Rizatriptan

insert:

Romosozumab	C11487	Severe established osteoporosis Initial treatment Patient must be at very high risk of fracture; AND Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND Patient must have had 2 or more fractures due to minimal trauma; AND Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a lifetime maximum of 12 months therapy; AND Patient must not have received treatment with teriparatide; OR Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy. Must be treated by a specialist; OR Must be treated by a consultant physician. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated. Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum. Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.	Compliance with Authority Required procedures
C11496	Severe established osteoporosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a lifetime maximum of 12 months therapy. Must be treated by a specialist; OR Must be treated by a consultant physician.	Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Secukinumab

(a)insert after entry for Circumstances Code “C9503”:

C10431	P10431	Non-radiographic axial spondyloarthritis Continuing treatment Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following: (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction. The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.	Compliance with Authority Required procedures
C10489	P10489	Non-radiographic axial spondyloarthritis Continuing treatment or Grandfather patient - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Continuing treatment restriction to complete 24 weeks treatment; 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 continuing treatment restriction or the grandfather restriction. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.	Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C11389	P11389	Non-radiographic axial spondyloarthritis Initial treatment - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; 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 one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The following must be provided at the time of application and documented in the patient's medical records: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. 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. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter. State in the application whether a loading dose regimen is intended or not. Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing. Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.	Compliance with Authority Required procedures
C11390	P11390	Non-radiographic axial spondyloarthritis Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patients) restriction to complete 20 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 20 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 20 weeks treatment; AND The treatment must provide no more than the balance of up to 20 weeks treatment. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.	Compliance with Authority Required procedures
C11432	P11432	Non-radiographic axial spondyloarthritis Grandfather treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this indication prior to 1 April 2021; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that was relieved by exercise but not rest, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months, prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have had one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The condition must have been diagnosed as non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria, prior to having commenced non-PBS-subsidised treatment with this biological medicine; AND The condition must have been sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI) prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The condition must have had presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent) prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The condition must have had BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium) prior to commencing non-PBS-subsidised treatment with this biological medicine; AND The treatment must not exceed a maximum of 24 weeks with this drug under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response to NSAIDs and must have been demonstrated prior to initiation of non-PBS subsidised treatment with this biological medicine for this condition: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The BASDAI score and CRP level must have been determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must have been no more than 1 month old at the time of initiating non-PBS subsidised treatment with this biological medicine for this condition. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. 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. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. 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 include: (a) a completed authority prescription; and (b) a completed PBS authority application form relevant to the indication and treatment phase (the latest version located at the website mentioned in the administrative note). The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C11447	P11447	Non-radiographic axial spondyloarthritis Initial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with biological medicines more than three times for this PBS-indication during the current treatment cycle; AND Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment. A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application. An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following: (a) a CRP measurement no greater than 10 mg per L; or (b) a CRP measurement reduced by at least 20% from baseline. The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment. BASDAI scores and CRP levels must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following must be provided at the time of application and documented in the patient's medical records: (a) the BASDAI score; and (b) the C-reactive protein (CRP) level. The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter. State in the application whether a loading dose regimen is intended or not. Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing. Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.	Compliance with Authority Required procedures
C11502	P11502	Non-radiographic axial spondyloarthritis Initial treatment - Initial 1 (New patient) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); AND The condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND The condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND The condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); AND The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter. State in the application whether a loading dose regimen is intended or not. Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing. Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1. The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used. If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication. If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance. The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and (b) C-reactive protein (CRP) level greater than 10 mg per L. The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. 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. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The authority application must include: (a) a completed authority prescription; and (b) a completed PBS authority application form relevant to the indication and treatment phase (the latest version located at the website mentioned in the administrative note). The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Teriparatide

substitute:

Teriparatide	C11464	Severe established osteoporosis Initial treatment Patient must be at very high risk of fracture; AND Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND Patient must have had 2 or more fractures due to minimal trauma; AND Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a lifetime maximum of 18 months therapy; AND Patient must not have received treatment with romosozumab; OR Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy. Must be treated by a specialist; OR Must be treated by a consultant physician. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated. Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum. Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.	Compliance with Authority Required procedures
C11486	Severe established osteoporosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a lifetime maximum of 18 months therapy. Must be treated by a specialist; OR Must be treated by a consultant physician.	Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Ustekinumab

omit entry for Circumstances Code “C9657” and substitute:

C9657

P9657

Severe Crohn disease
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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
An application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
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 the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.
Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend continuing treatment beyond 24 months.

Compliance with Written Authority Required procedures

Schedule 4, Part 3 - General statement for drugs for the treatment of hepatitis C

substitute:

Part 3—General statement for drugs for the treatment of hepatitis C

1 Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(1)the patient has been assessed in accordance with paragraph 2 of this Part; and

(2) the patient is:

(a) treated by a medical practitioner or an authorised nurse practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or

(b) treated by a medical practitioner or an authorised nurse practitioner in consultation with:

(i) a gastroenterologist; or

(ii) a hepatologist; or

(iii) an infectious diseases physician.

2 Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

(1)documented the following information in the patient’s medical records:

(a)evidence of chronic hepatitis C infection; and

(b)where possible, evidence of the patient’s hepatitis C virus genotype; and

(2)chosen a regimen in accordance with paragraph 3 of this Part; and

(3)collected the following information for the purposes of the authority application:

(a)whether the patient is:

(i)cirrhotic; or

(ii)non-cirrhotic

(b)details of the previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir or glecaprevir with pibrentasvir for treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).

(4)In this paragraph, evidence of chronic hepatitis C infection is documentation of:

(a)repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

(b)test result showing hepatitis C virus ribonucleic acid (RNA) positive.

3 Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

(1)is a kind of patient mentioned for an Item in column 2 of the following table; and

(2)is to receive one of the regimens mentioned in column 3 of the same Item of the following table.

Item	Kind of patient	Regimen
1	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) GLECAPREVIR with PIBRENTASVIR for 8 weeks.
2	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 8 weeks; or (d) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (e) GLECAPREVIR with PIBRENTASVIR 16 weeks.
3	Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Either: (a) LEDIPASVIR with SOFOSBUVIR for 8 weeks; or (b) LEDIPASVIR with SOFOSBUVIR for 12 weeks
4	Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	LEDIPASVIR with SOFOSBUVIR for 12 weeks
5	Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
6	Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
7	Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
8	Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
9	Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
10	Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
11	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is non-cirrhotic.	Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
12	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is non-cirrhotic.	Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
13	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment naïve; and (c) who is cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) GLECAPREVIR with PIBRENTASVIR for 8 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks
14	Patient: (a) all genotypes (pan-genotypic); and (b) who is treatment experienced; and (c) who is cirrhotic.	Either: (a) SOFOSBUVIR with VELPATASVIR for 12 weeks; or (b) SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or (c) GLECAPREVIR with PIBRENTASVIR for 12 weeks; or (d) GLECAPREVIR with PIBRENTASVIR 16 weeks.
15	Patient: (a) with Genotype 1; and (b) who is treatment naïve; and (c) who is cirrhotic.	LEDIPASVIR with SOFOSBUVIR for 12 weeks
16	Patient: (a) with Genotype 1; and (b) who is treatment experienced; and (c) who is cirrhotic.	LEDIPASVIR with SOFOSBUVIR for 24 weeks
17	Patient: (a) with Genotype 2; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
18	Patient: (a) with Genotype 2; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
19	Patient: (a) with Genotype 3; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
20	Patient: (a) with Genotype 3; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
21	Patient: (a) with Genotype 4; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
22	Patient: (a) with Genotype 4; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
23	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment naïve; and (c) who is cirrhotic.	Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
24	Patient: (a) with: (i) Genotype 5; or (ii) Genotype 6; and (b) who is treatment experienced; and (c) who is cirrhotic.	Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).

Schedule 5, after entry for Abacavir with lamivudine

insert:

Adalimumab	GRP-24872	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Humira
Injection 40 mg in 0.8 mL pre-filled pen	Injection	Amgevita Hadlima Humira Hyrimoz Idacio
GRP-24874	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Humira
Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Amgevita Humira
GRP-24876	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Humira
Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Amgevita Hadlima Humira Hyrimoz Idacio

Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [GRP-17061]

(a)insert in alphabetical order in the column headed “Brand”: APO-Esomeprazole

(b)insert in alphabetical order in the column headed “Brand”: Esopreze

Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) [GRP-17188]

(a)insert in alphabetical order in the column headed “Brand”: APO-Esomeprazole

(b)insert in alphabetical order in the column headed “Brand”: Esopreze

Schedule 5, entry for Omeprazole in the form Tablet 20 mg [GRP-14650]

insert in alphabetical order in the column headed “Brand”: Maxor EC Tabs

Schedule 5, after entry for Salbutamol

insert:

Sertraline	GRP-24879	Tablet 50 mg (as hydrochloride)	Oral	Auro-Sertraline 50 Eleva 50 NOUMED SERTRALINE Sertraline AN Zoloft
Tablet 50 mg (as hydrochloride) (USP)	Oral	Sertraline tablets USP (Medsurge)
GRP-24880	Tablet 100 mg (as hydrochloride)	Oral	Auro-Sertraline 100 Eleva 100 NOUMED SERTRALINE Sertraline AN Zoloft
Tablet 100 mg (as hydrochloride) (USP)	Oral	Sertraline tablets USP (Medsurge)
GRP-24896	Tablet 100 mg (as hydrochloride)	Oral	APO-Sertraline Auro-Sertraline 100 Eleva 100 NOUMED SERTRALINE Sertra 100 Sertraline AN Sertraline Sandoz Sertraline generichealth Setrona Zoloft
Tablet 100 mg (as hydrochloride) (USP)	Oral	Sertraline tablets USP (Medsurge)
GRP-24903	Tablet 50 mg (as hydrochloride)	Oral	APO-Sertraline Auro-Sertraline 50 Eleva 50 NOUMED SERTRALINE Sertra 50 Sertraline AN Sertraline Sandoz Sertraline generichealth Setrona Zoloft
Tablet 50 mg (as hydrochloride) (USP)	Oral	Sertraline tablets USP (Medsurge)

Schedule 5, entry for Tenofovir in the form Tablet containing tenofovir disoproxil fumarate 300 mg [GRP-21636]

insert in alphabetical order in the column headed “Brand”: Tenofovir Sandoz

Schedule 6, after entry for Secukinumab

insert:

Selexipag	Tablet 200 micrograms	Oral
Selexipag	Tablet 400 micrograms	Oral
Selexipag	Tablet 600 micrograms	Oral
Selexipag	Tablet 800 micrograms	Oral
Selexipag	Tablet 1 mg	Oral
Selexipag	Tablet 1.2 mg	Oral
Selexipag	Tablet 1.4 mg	Oral
Selexipag	Tablet 1.6 mg	Oral