Commonwealth Coat of Arms of Australia

 

PB 76 of 2024

 

National Health (Listing of Pharmaceutical Benefits) Amendment (August Update) Instrument 2024

 

National Health Act 1953

 

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

Dated 30 July 2024

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

 

 

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

National Health (Listing of Pharmaceutical Benefits) Instrument 2024
(PB 26 of 2024). 2

1 Name

(1)           This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment (August Update) Instrument 2024.

(2)           This Instrument may also be cited as PB 76 of 2024.

2 Commencement

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

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

1 August 2024

1 August 2024

Note: This table relates only to the provisions of this instrument as originally made.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

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

3 Authority

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

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024)

[1]                   Schedule 1, Part 1, entry for Acamprosate

                           omit:

Acamprosate

Tablet (enteric coated) containing acamprosate calcium 333 mg

Oral

Acamprosate Mylan

AL

MP NP

C5366

 

180

1

 

180

 

 

[2]                   Schedule 1, Part 1, entry for Acarbose in the form Tablet 50 mg

                           omit:

Acarbose

Tablet 50 mg

Oral

Acarbose Mylan

AF

MP NP

 

 

90

5

 

90

 

 

Acarbose

Tablet 50 mg

Oral

Acarbose Mylan

AF

MP NP

 

P14238

180

5

 

90

 

 

[3]                   Schedule 1, Part 1, after entry for Aciclovir in the form Tablet 800 mg [Brand: APO-Aciclovir]

                           insert:

Aciclovir

Tablet 800 mg

Oral

ARX-ACICLOVIR

XT

MP NP

C5959 C5967

 

35

0

 

35

 

 

[4]                   Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe

                           substitute:

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

VE

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

VE

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

VE

MP

C9715 C11715 C11716 C11761 C11852 C11854 C11855

P9715 P11715 P11716 P11761 P11852 P11854 P11855

2

3

 

2

 

 

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

VE

MP

C11717 C11767 C11853 C11903 C11966 C15446 C15450

P11717 P11767 P11853 P11903 P11966 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 20 mg in 0.2 mL pre-filled syringe

Injection

Humira

VE

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

[5]                   Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe

                           substitute:

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Abrilada

PF

MP

C11713

P11713

2

0

 

2

 

 

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Abrilada

PF

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Abrilada

PF

MP

C9715 C11715 C11716 C11761 C11852 C11854 C11855

P9715 P11715 P11716 P11761 P11852 P11854 P11855

2

3

 

2

 

 

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Abrilada

PF

MP

C11579 C11717 C11718 C11767 C11853 C11903 C11966

P11579 P11717 P11718 P11767 P11853 P11903 P11966

2

5

 

2

 

 

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Amgevita

XT

MP

C11713

P11713

2

0

 

1

 

 

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Amgevita

XT

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

1

 

C(100)

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Amgevita

XT

MP

C9715 C11715 C11716 C11761 C11852 C11854 C11855

P9715 P11715 P11716 P11761 P11852 P11854 P11855

2

3

 

1

 

 

Adalimumab

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Amgevita

XT

MP

C11579 C11717 C11718 C11767 C11853 C11903 C11966

P11579 P11717 P11718 P11767 P11853 P11903 P11966

2

5

 

1

 

 

[6]                   Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen

                           substitute:

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C11529 C12272 C12315

P11529 P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

LR

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14498 C14655 C14662 C14670

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14498 P14655 P14662 P14670

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C11704 C11711 C11717 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14656 C14713 C14730 C15446 C15450

P11704 P11711 P11717 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14656 P14713 P14730 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C12272 C12315

P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Humira

VE

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C11529 C12272 C12315

P11529 P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Yuflyma

EW

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

[7]                   Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Adalicip; Maximum Quantity: See Note 3; Number of Repeats: See Note 3]

                           insert in numerical order in the column headed “Circumstances”: C14107 C14136


[8]                   Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Adalicip]

omit:

Adalimumab

Injection 40 mg in 0.4 mL pre‑filled syringe

Injection

Adalicip

LR

MP

C14107 C14136

P14107 P14136

2

5

 

2

 

C(100)

[9]                   Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: See Note 3; Number of Repeats: See Note 3]

                           insert in numerical order in the column headed “Circumstances”: C14107 C14136

[10]               Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira]

omit:

Adalimumab

Injection 40 mg in 0.4 mL pre‑filled syringe

Injection

Humira

VE

MP

C14107 C14136

P14107 P14136

2

5

 

2

 

C(100)

[11]               Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: See Note 3; Number of Repeats: See Note 3]

                           insert in numerical order in the column headed “Circumstances”: C14107 C14136

[12]               Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma]

omit:

Adalimumab

Injection 40 mg in 0.4 mL pre‑filled syringe

Injection

Yuflyma

EW

MP

C14107 C14136

P14107 P14136

2

5

 

2

 

C(100)

[13]               Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen

                           substitute:

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C11529 C12272 C12315

P11529 P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Abrilada

PF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C11529 C12272 C12315

P11529 P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Amgevita

XT

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C11529 C12272 C12315

P11529 P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hadlima

RF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C11529 C12272 C12315

P11529 P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Hyrimoz

SZ

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C12273

P12273

4

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C11529 C12272 C12315

P11529 P12272 P12315

4

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled pen

Injection

Idacio

PK

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15249 C15309 C15319

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15249 P15309 P15319

6

0

 

2

 

 

[14]               Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe

                           substitute:

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C9386 C12174 C12194 C13599 C13681 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9386 P12174 P12194 P13599 P13681 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Abrilada

PF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

XT

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

XT

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

XT

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

XT

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

XT

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

XT

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Amgevita

XT

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre‑filled syringe

Injection

Amgevita

XT

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hadlima

RF

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Hyrimoz

SZ

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

6

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C11713 C15473

P11713 P15473

2

0

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

See Note 3

See Note 3

 

2

 

C(100)

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

2

2

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C9064 C9386 C11861 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673

P9064 P9386 P11861 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673

2

3

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

2

4

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

2

5

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C15474 C15489

P15474 P15489

2

6

 

2

 

 

Adalimumab

Injection 40 mg in 0.8 mL pre-filled syringe

Injection

Idacio

PK

MP

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

6

0

 

2

 

 

[15]               Schedule 1, Part 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 3; Number of Repeats: 0]

(a)           omit from the column headed “Circumstances”: C7714

(b)           omit from the column headed “Circumstances”: C9636

[16]               Schedule 1, Part 1, entry for Alemtuzumab in the form Solution concentrate for I.V. infusion 12 mg in 1.2 mL [Maximum Quantity: 5; Number of Repeats: 0]

(a)           omit from the column headed “Circumstances”: C6847

(b)           omit from the column headed “Circumstances”: C9589

[17]               Schedule 1, Part 1, omit entries for Alirocumab

[18]               Schedule 1, Part 1, after entry for Allopurinol in the form Tablet 100 mg [Brand: Allosig; Maximum Quantity: 400; Number of Repeats: 2]

                           insert:

Allopurinol

Tablet 100 mg

Oral

APO-ALLOPURINOL

TX

MP NP

 

 

200

2

 

200

 

 

Allopurinol

Tablet 100 mg

Oral

APO-ALLOPURINOL

TX

MP NP

 

P14238

400

2

 

200

 

 

[19]               Schedule 1, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid in the form Oral liquid 125 mL, 36 (TYR Anamix junior LQ)

                           omit from the column headed “Listed Drug”: Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid
substitute: Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexaenoic acid

[20]               Schedule 1, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid in the form Oral liquid 125 mL, 36 (HCU Anamix junior LQ)

                           omit from the column headed “Listed Drug”: Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid
substitute: Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexaenoic acid

[21]               Schedule 1, Part 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 125 mL, 30 (PKU Lophlex LQ 20)

                           insert:

Amino acid formula with vitamins and minerals without phenylalanine

Oral liquid 125 mL, 30 (PKU Lophlex Select LQ)

Oral

PKU Lophlex Select LQ

NU

MP NP

C4295

 

4

5

 

1

 

 

[22]               Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid

                           omit from the column headed “Listed Drug”: Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid
substitute: Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexaenoic acid

[23]               Schedule 1, Part 1, entry for Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine in the form Oral powder 400 g (PKU Start)

                           omit from the column headed “Pack Quantity”: 1 substitute: 4

[24]               Schedule 1, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

                           omit:

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

Oral powder 400 g (Alfamino)

Oral

Alfamino

NT

MP NP

C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4415 C5945 C5974

 

8

5

 

1

 

 

[25]               Schedule 1, Part 1, entry for Amoxicillin in the form Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

                           substitute:

Amoxicillin

Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Oral

Amoxil

AS

PDP

 

 

1

0

 

1

 

 

Amoxicillin

Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Oral

Amoxil

AS

MP NP

 

 

1

1

 

1

 

 

Amoxicillin

Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL

Oral

Amoxil

AS

MP NP

 

P5863

1
CN5863

1
CN5863

 

1

 

 

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

                           insert:

Amoxicillin with clavulanic acid

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

Alphaclav Duo Viatris

AL

MP NP MW

C5832 C5893

P5832 P5893

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

Alphaclav Duo Viatris

AL

PDP

C5833 C5894

P5833 P5894

10

0

 

10

 

 

Amoxicillin with clavulanic acid

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

Oral

Alphaclav Duo Viatris

AL

MP NP

C10405

P10405

20

0

 

10

 

 

[27]               Schedule 1, Part 1, entry for Arsenic

substitute:

Arsenic

Injection concentrate containing arsenic trioxide 10 mg in 10 mL

Injection

Arsenic Trioxide Accord

OC

MP

C4793 C5997 C6018

 

See Note 3

See Note 3

 

10

 

D(100)

Arsenic

Injection concentrate containing arsenic trioxide 10 mg in 10 mL

Injection

Arsenic Trioxide Juno

JU

MP

C4793 C5997 C6018

 

See Note 3

See Note 3

 

10

 

D(100)

Arsenic

Injection concentrate containing arsenic trioxide 10 mg in 10 mL

Injection

Arsenic Trioxide‑AFT

AE

MP

C4793 C5997 C6018

 

See Note 3

See Note 3

 

10

 

D(100)

Arsenic

Injection concentrate containing arsenic trioxide 10 mg in 10 mL

Injection

Phenasen

FF

MP

C4793 C5997 C6018

 

See Note 3

See Note 3

 

10

 

D(100)

[28]               Schedule 1, Part 1, entry for Atezolizumab

substitute:

Atezolizumab

Solution concentrate for I.V. infusion 840 mg in 14 mL

Injection

Tecentriq

RO

MP

C10215 C10257 C10509 C10972 C13446 C13451

 

See Note 3

See Note 3

 

1

 

PB(100)

Atezolizumab

Solution concentrate for I.V. infusion 1200 mg in 20 mL

Injection

Tecentriq

RO

MP

C10125 C10206 C10216 C10297 C10521 C10917 C10939 C13442 C13443 C13448

 

See Note 3

See Note 3

 

1

 

PB(100)

Atezolizumab

Solution for subcutaneous injection 1875 mg in 15 mL

Injection

Tecentriq SC

RO

MP

C10206 C10939

P10206 P10939

1

3

 

1

 

 

Atezolizumab

Solution for subcutaneous injection 1875 mg in 15 mL

Injection

Tecentriq SC

RO

MP

C10521

P10521

1

4

 

1

 

 

Atezolizumab

Solution for subcutaneous injection 1875 mg in 15 mL

Injection

Tecentriq SC

RO

MP

C10125 C13443 C13448

P10125 P13443 P13448

1

5

 

1

 

 

Atezolizumab

Solution for subcutaneous injection 1875 mg in 15 mL

Injection

Tecentriq SC

RO

MP

C10216 C10297 C15455

P10216 P10297 P15455

1

7

 

1

 

 

[29]               Schedule 1, Part 1, entry for Avelumab

substitute:

Avelumab

Solution concentrate for I.V. infusion 200 mg in 10 mL

Injection

Bavencio

SG

MP

C8947 C10023 C13290 C15485

 

See Note 3

See Note 3

 

1

 

D(100)

[30]               Schedule 1, Part 1, entry for Axitinib in the form Tablet 1 mg [Maximum Quantity: 56; Number of Repeats: 2]

omit from the column headed “Variations”: V7433

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

omit from the column headed “Variations”: V8588

[32]               Schedule 1, Part 1, entry for Axitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 2]

omit from the column headed “Variations”: V7433

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

omit from the column headed “Variations”: V8588

[34]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: APO‑Azithromycin; Maximum Quantity: 2; Number of Repeats: 0]

insert in numerical order in the column headed “Purposes”: P5718 P5772

[35]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: APO‑Azithromycin; Maximum Quantity: 2; Number of Repeats: 2]

insert in the column headed “Purposes”: P5637

[36]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Azithromycin Mylan; Maximum Quantity: 2; Number of Repeats: 0]

insert in numerical order in the column headed “Purposes”: P5718 P5772

[37]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Azithromycin Mylan; Maximum Quantity: 2; Number of Repeats: 2]

insert in the column headed “Purposes”: P5637

[38]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Azithromycin Sandoz; Maximum Quantity: 2; Number of Repeats: 0]

insert in numerical order in the column headed “Purposes”: P5718 P5772

[39]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Azithromycin Sandoz; Maximum Quantity: 2; Number of Repeats: 2]

insert in the column headed “Purposes”: P5637

[40]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Azithromycin Viatris; Maximum Quantity: 2; Number of Repeats: 0]

insert in numerical order in the column headed “Purposes”: P5718 P5772

[41]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Azithromycin Viatris; Maximum Quantity: 2; Number of Repeats: 2]

insert in the column headed “Purposes”: P5637

[42]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: ZITHRO; Maximum Quantity: 2; Number of Repeats: 0]

insert in numerical order in the column headed “Purposes”: P5718 P5772


[43]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: ZITHRO; Maximum Quantity: 2; Number of Repeats: 2]

insert in the column headed “Purposes”: P5637

[44]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Zithromax; Maximum Quantity: 2; Number of Repeats: 0]

insert in numerical order in the column headed “Purposes”: P5718 P5772

[45]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Brand: Zithromax; Maximum Quantity: 2; Number of Repeats: 2]

insert in the column headed “Purposes”: P5637

[46]               Schedule 1, Part 1, entry for Azithromycin in the form Tablet 600 mg (as dihydrate)

(a)           omit from the column headed “Maximum Quantity”: See Note 3 substitute: 16

(b)           omit from the column headed “Number of Repeats”: See Note 3 substitute: 5

[47]               Schedule 1, Part 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL [Brand: Bacthecal]

(a)           omit from the column headed “Maximum Quantity”: See Note 3 substitute: 10

(b)           omit from the column headed “Number of Repeats”: See Note 3 substitute: 0

[48]               Schedule 1, Part 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL [Brand: Lioresal Intrathecal]

(a)           omit from the column headed “Maximum Quantity”: See Note 3 substitute: 10

(b)           omit from the column headed “Number of Repeats”: See Note 3 substitute: 0

[49]               Schedule 1, Part 1, entry for Baclofen in the form Intrathecal injection 10 mg in 5 mL [Brand: Sintetica Baclofen Intrathecal]

(a)           omit from the column headed “Maximum Quantity”: See Note 3 substitute: 10

(b)           omit from the column headed “Number of Repeats”: See Note 3 substitute: 0

[50]               Schedule 1, Part 1, entry for Baclofen in the form Intrathecal injection 40 mg in 20 mL

(a)           omit from the column headed “Maximum Quantity”: See Note 3 substitute: 2

(b)           omit from the column headed “Number of Repeats”: See Note 3 substitute: 0


[51]               Schedule 1, Part 1, entry for Beclometasone with formoterol in the form Pressurised inhalation containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per dose,120 dose

omit from the column headed “Circumstances”: C11057 substitute: C15469

[52]               Schedule 1, Part 1, entry for Benralizumab

substitute:

Benralizumab

Injection 30 mg in 1 mL single dose pre‑filled pen

Injection

Fasenra Pen

AP

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

[53]               Schedule 1, Part 1, entry for Benzatropine in the form Injection containing benzatropine mesilate 2 mg in 2 mL

substitute:

Benzatropine

Injection containing benzatropine mesilate 2 mg in 2 mL

Injection

Benzatropine Injection

FF

MP NP PDP

 

 

5

0

 

5

 

 

[54]               Schedule 1, Part 1, entry for Benzylpenicillin in the form Powder for injection 3 g (as sodium)

substitute:

Benzylpenicillin

Powder for injection 3 g (as sodium)

Injection

BenPen

CS

MP NP PDP

 

 

10

0

 

1

 

 

[55]               Schedule 1, Part 1, entry for Betaxolol

                           substitute:

Betaxolol

Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL

Application to the eye

Betoptic

NV

MP AO

 

 

1

5

 

1

 

 

Betaxolol

Eye drops, solution, 5 mg (as hydrochloride) per mL, 5 mL

Application to the eye

BetoQuin

NM

MP AO

 

 

1

5

 

1

 

 

[56]               Schedule 1, Part 1, entry for Bimatoprost

substitute:

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Bimatoprost Sandoz

SZ

MP AO

 

 

1

5

 

1

 

 

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Bimprozt

TY

MP AO

 

 

1

5

 

1

 

 

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Bimtop

AF

MP AO

 

 

1

5

 

1

 

 

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

Application to the eye

Lumigan

VE

MP AO

 

 

1

5

 

1

 

 

Bimatoprost

Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30

Application to the eye

Lumigan PF

VE

MP AO

 

 

1

5

 

1

 

 

[57]               Schedule 1, Part 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)

                           omit:

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan Cipla

LR

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

60

 

D(100)

[58]               Schedule 1, Part 1, entry for Brentuximab vedotin

substitute:

Brentuximab vedotin

Powder for I.V. infusion 50 mg

Injection

Adcetris

TK

MP

C13134 C13179 C13181 C13182 C13208 C13209 C13212 C13231 C13259 C13261

 

See Note 3

See Note 3

 

1

 

D(100)

[59]               Schedule 1, Part 1, entry for Brimonidine

                           substitute:

Brimonidine

Eye drops containing brimonidine tartrate 1.5 mg per mL, 5 mL

Application to the eye

Alphagan P 1.5

VE

MP AO

 

 

1

5

 

1

 

 

Brimonidine

Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

Application to the eye

Alphagan

VE

MP AO

 

 

1

5

 

1

 

 

Brimonidine

Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

Application to the eye

Enidin

VB

MP AO

 

 

1

5

 

1

 

 

[60]               Schedule 1, Part 1, entry for Brinzolamide

                           substitute:

Brinzolamide

Eye drops 10 mg per mL, 5 mL

Application to the eye

Azopt

NV

MP AO

 

 

1

5

 

1

 

 

Brinzolamide

Eye drops 10 mg per mL, 5 mL

Application to the eye

BrinzoQuin

NM

MP AO

 

 

1

5

 

1

 

 

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

(a)           insert in numerical order in the column headed “Circumstances”: C15454

(b)           insert in numerical order in the column headed “Purposes”: P15454

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

(a)           insert in numerical order in the column headed “Circumstances”: C15479 C15518

(b)           insert in numerical order in the column headed “Purposes”: P15479 P15518

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

(a)           insert in numerical order in the column headed “Circumstances”: C15454

(b)           insert in numerical order in the column headed “Purposes”: P15454

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

(a)           insert in numerical order in the column headed “Circumstances”: C15479 C15518

(b)           insert in numerical order in the column headed “Purposes”: P15479 P15518

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

(a)           insert in numerical order in the column headed “Circumstances”: C15454

(b)           insert in numerical order in the column headed “Purposes”: P15454

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

(a)           insert in numerical order in the column headed “Circumstances”: C15479 C15518

(b)           insert in numerical order in the column headed “Purposes”: P15479 P15518

[67]               Schedule 1, Part 1, entry for Calcium in the form Tablet, chewable, 500 mg (as carbonate) [Authorised Prescriber: MP; Maximum Quantity: 240; Number of Repeats: 1]

                           omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

[68]               Schedule 1, Part 1, entry for Calcium in the form Tablet, chewable, 500 mg (as carbonate)

                           omit:

Calcium

Tablet, chewable, 500 mg (as carbonate)

Oral

Cal-500

PP

NP

C4586

 

240

1

 

120

 

 

[69]               Schedule 1, Part 1, entry for Calcium in the form Tablet, chewable, 500 mg (as carbonate) [Maximum Quantity: 480; Number of
Repeats: 1]

                           omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

[70]               Schedule 1, Part 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Brand: APO‑Cephalexin; Maximum Quantity: 20; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 250 mg (as monohydrate)

Oral

APO‑Cephalexin

TX

PDP

 

 

20

0

 

20

 

 

[71]               Schedule 1, Part 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Brand: Ibilex 250; Maximum Quantity: 20; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 250 mg (as monohydrate)

Oral

Ibilex 250

AF

PDP

 

 

20

0

 

20

 

 

[72]               Schedule 1, Part 1, entry for Cefalexin in the form Capsule 250 mg (as monohydrate) [Brand: Keflex; Maximum Quantity: 20; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 250 mg (as monohydrate)

Oral

Keflex

AS

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

APO‑Cephalexin

TX

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

Blooms The Chemist Cefalexin

BG

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

Cefalexin Sandoz

SZ

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

Cephalex 500

CR

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

Cephalexin generichealth

GQ

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

Ibilex 500

AF

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

Keflex

AS

PDP

 

 

20

0

 

20

 

 

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

(a)           omit from the column headed “Authorised Prescriber”: MP NP MW substitute: MP NP MW PDP

(b)           omit:

Cefalexin

Capsule 500 mg (as monohydrate)

Oral

NOUMED CEFALEXIN

VO

PDP

 

 

20

0

 

20

 

 

[81]               Schedule 1, Part 1, entry for Cefazolin

                           omit:

Cefazolin

Powder for injection 500 mg (as sodium)

Injection

Cefazolin-AFT

AE

MP NP

C5826 C5867 C5881 C5890

 

10

0

 

5

 

 

[82]               Schedule 1, Part 1, entry for Cefazolin in the form Powder for injection 2 g (as sodium)

                           omit:

Cefazolin

Powder for injection 2 g (as sodium)

Injection

Cephazolin Alphapharm

AF

MP NP

C5826 C5867 C5881 C5890

 

10

0

 

10

 

 

[83]               Schedule 1, Part 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)

                           omit:

Ceftriaxone

Powder for injection 1 g (as sodium)

Injection

Ceftriaxone Viatris

AL

MP NP

C5830 C5862 C5868

 

5

0

 

5

 

 

[84]               Schedule 1, Part 1, entry for Cetuximab in the form Solution for I.V. infusion 100 mg in 20 mL

(a)           omit from the column headed “Circumstances”: C4788 substitute: C4785 C4788 C4794 C4908 C4912 C12016 C12045 C12470 C12483

(b)           omit from the column headed “Purposes”: P4788

(c)           omit:

Cetuximab

Solution for I.V. infusion 100 mg in 20 mL

Injection

Erbitux

SG

MP

C4785 C4794

P4785 P4794

See Note 3

See Note 3

 

1

 

D(100)

Cetuximab

Solution for I.V. infusion 100 mg in 20 mL

Injection

Erbitux

SG

MP

C4908 C12045 C12483

P4908 P12045 P12483

See Note 3

See Note 3

 

1

 

D(100)

Cetuximab

Solution for I.V. infusion 100 mg in 20 mL

Injection

Erbitux

SG

MP

C12016 C12470

P12016 P12470

See Note 3

See Note 3

 

1

 

D(100)

Cetuximab

Solution for I.V. infusion 100 mg in 20 mL

Injection

Erbitux

SG

MP

C4912

P4912

See Note 3

See Note 3

 

1

 

D(100)

[85]               Schedule 1, Part 1, entry for Cetuximab in the form Solution for I.V. infusion 500 mg in 100 mL

(a)           omit from the column headed “Circumstances”: C4788 substitute: C4785 C4788 C4794 C4908 C4912 C12016 C12045 C12470 C12483

(b)           omit from the column headed “Purposes”: P4788

(c)           omit:

Cetuximab

Solution for I.V. infusion 500 mg in 100 mL

Injection

Erbitux

SG

MP

C4785 C4794

P4785 P4794

See Note 3

See Note 3

 

1

 

D(100)

Cetuximab

Solution for I.V. infusion 500 mg in 100 mL

Injection

Erbitux

SG

MP

C4908 C12045 C12483

P4908 P12045 P12483

See Note 3

See Note 3

 

1

 

D(100)

Cetuximab

Solution for I.V. infusion 500 mg in 100 mL

Injection

Erbitux

SG

MP

C12016 C12470

P12016 P12470

See Note 3

See Note 3

 

1

 

D(100)

Cetuximab

Solution for I.V. infusion 500 mg in 100 mL

Injection

Erbitux

SG

MP

C4912

P4912

See Note 3

See Note 3

 

1

 

D(100)

[86]               Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 90 mg (as hydrochloride)

                           omit:

Cinacalcet

Tablet 90 mg (as hydrochloride)

Oral

Cinacalcet Mylan

AF

MP NP

C10068

 

28

5

 

28

 

 

Cinacalcet

Tablet 90 mg (as hydrochloride)

Oral

Cinacalcet Mylan

AF

MP

C10063 C10067 C10073

 

56

5

 

28

 

C(100)

[87]               Schedule 1, Part 1, entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL [Brand: Clopine Suspension]

(a)           omit from the column headed “Circumstances”: C10063 C10067 C10073  substitute: C4998 C5015 C9490

(b)           omit from the column headed “Maximum Quantity”: 56  substitute: 1

(c)           omit from the column headed “Number of Repeats”: 5   substitute: 0

[88]               Schedule 1, Part 1, entry for Clozapine in the form Oral liquid 50 mg per mL, 100 mL [Brand: Versacloz]

(a)           omit from the column headed “Circumstances”: C10063 C10067 C10073  substitute: C4998 C5015 C9490

(b)           omit from the column headed “Maximum Quantity”: 56  substitute: 1

(c)           omit from the column headed “Number of Repeats”: 5   substitute: 0


[89]               Schedule 1, Part 1, entry for Codeine in the form Tablet containing codeine phosphate hemihydrate 30 mg [Maximum Quantity: 10; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: PDP  substitute: MP NP PDP

(b)           omit:

Codeine

Tablet containing codeine phosphate hemihydrate 30 mg

Oral

Aspen Pharma Pty Ltd

AS

MP NP

C10766

P10766

10

0

 

20

 

 

[90]               Schedule 1, Part 1, entry for Codeine with paracetamol

                           substitute:

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

APO‑ Paracetamol/Codeine 500/30

TX

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

APO‑ Paracetamol/Codeine 500/30

TX

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

APO‑ Paracetamol/Codeine 500/30

TX

PDP

C10768

P10768

20

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

APX‑Paracetamol/Codeine

TY

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

APX‑Paracetamol/Codeine

TY

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

APX‑Paracetamol/Codeine

TY

PDP

C10768

P10768

20

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Codalgin Forte

AF

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Codalgin Forte

AF

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Codalgin Forte

AF

PDP

C10768

P10768

20

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Codapane Forte 500/30

AL

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Codapane Forte 500/30

AL

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Codapane Forte 500/30

AL

PDP

C10768

P10768

20

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Comfarol Forte

SZ

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Comfarol Forte

SZ

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Comfarol Forte

SZ

PDP

C10768

P10768

20

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Panadeine Forte

SW

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Panadeine Forte

SW

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Panadeine Forte

SW

PDP

C10768

P10768

20

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Paracetamol/Codeine GH 500/30

GQ

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Paracetamol/Codeine GH 500/30

GQ

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Paracetamol/Codeine GH 500/30

GQ

PDP

C10768

P10768

20

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Prodeine Forte

AV

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Prodeine Forte

AV

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Codeine with paracetamol

Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg

Oral

Prodeine Forte

AV

PDP

C10768

P10768

20

0

 

20

 

 

[91]               Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 75 mg (as mesilate)

                           omit:

Dabigatran etexilate

Capsule 75 mg (as mesilate)

Oral

PHARMACOR DABIGATRAN

CR

MP NP

C4402

P4402

60

0

 

60

 

 

[92]               Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 20 mg [Brand: DASATINIB-TEVA; Maximum Quantity: 60; Number of Repeats: 5]

                           insert:

Dasatinib

Tablet 20 mg

Oral

Dasatinib Viatris

AL

MP

C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

60

2

 

60

 

 

Dasatinib

Tablet 20 mg

Oral

Dasatinib Viatris

AL

MP

C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

60

5

 

60

 

 

[93]               Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 50 mg [Brand: DASATINIB-TEVA; Maximum Quantity: 60; Number of Repeats: 5]

                           insert:

Dasatinib

Tablet 50 mg

Oral

Dasatinib Viatris

AL

MP

C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

60

2

 

60

 

 

Dasatinib

Tablet 50 mg

Oral

Dasatinib Viatris

AL

MP

C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

60

5

 

60

 

 

[94]               Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 70 mg [Brand: DASATINIB-TEVA; Maximum Quantity: 60; Number of Repeats: 5]

                           insert:

Dasatinib

Tablet 70 mg

Oral

Dasatinib Viatris

AL

MP

C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

60

2

 

60

 

 

Dasatinib

Tablet 70 mg

Oral

Dasatinib Viatris

AL

MP

C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

60

5

 

60

 

 

[95]               Schedule 1, Part 1, after entry for Dasatinib in the form Tablet 100 mg [Brand: DASATINIB-TEVA; Maximum Quantity: 30; Number of Repeats: 5]

                           insert:

Dasatinib

Tablet 100 mg

Oral

Dasatinib Viatris

AL

MP

C9367 C9468 C9469 C9549

P9367 P9468 P9469 P9549

30

2

 

30

 

 

Dasatinib

Tablet 100 mg

Oral

Dasatinib Viatris

AL

MP

C12522 C12524 C12530 C12561 C12565 C12570

P12522 P12524 P12530 P12561 P12565 P12570

30

5

 

30

 

 

[96]               Schedule 1, Part 1, entry for Durvalumab

                           substitute:

Durvalumab

Solution concentrate for I.V. infusion 120 mg in 2.4 mL

Injection

Imfinzi

AP

MP

C10206 C10509 C12271 C14708 C15500

 

See Note 3

See Note 3

 

1

 

D(100)

Durvalumab

Solution concentrate for I.V. infusion 500 mg in 10 mL

Injection

Imfinzi

AP

MP

C10206 C10509 C12271 C14708 C15500

 

See Note 3

See Note 3

 

1

 

D(100)

[97]               Schedule 1, Part 1, entry for Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

                           insert as first entry:

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

Pack containing 28 sachets containing granules elexacaftor 80 mg with tezacaftor 40 mg and with ivacaftor 60 mg and 28 sachets containing granules ivacaftor 59.5 mg

Oral

Trikafta

VR

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

Pack containing 28 sachets containing granules elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 sachets containing granules ivacaftor 75 mg

Oral

Trikafta

VR

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

[98]               Schedule 1, Part 1, entry for Ezetimibe

                           omit:

Ezetimibe

Tablet 10 mg

Oral

Blooms The Chemist Ezetimibe

IB

MP NP

C7966 C7990 C7996

P7966 P7990 P7996

30

5

 

30

 

 

Ezetimibe

Tablet 10 mg

Oral

Blooms The Chemist Ezetimibe

IB

MP NP

C14249 C14283 C14310

P14249 P14283 P14310

60

5

 

30

 

 

[99]               Schedule 1, Part 1, entry for Felodipine in the form Tablet 2.5 mg (extended release) [Brand: Felodur ER 2.5 mg]

                           omit from the column headed “Responsible Person” (all instances): TX substitute (all instances): IY

[100]           Schedule 1, Part 1, entry for Felodipine in the form Tablet 2.5 mg (extended release) [Brand: Plendil ER]

                           omit from the column headed “Responsible Person” (all instances): GX substitute (all instances): IX

[101]           Schedule 1, Part 1, entry for Felodipine in the form Tablet 5 mg (extended release) [Brand: Felodur ER 5 mg]

                           omit from the column headed “Responsible Person” (all instances): TX substitute (all instances): IY

[102]           Schedule 1, Part 1, entry for Felodipine in the form Tablet 5 mg (extended release) [Brand: Plendil ER]

                           omit from the column headed “Responsible Person” (all instances): GX substitute (all instances): IX

[103]           Schedule 1, Part 1, entry for Felodipine in the form Tablet 10 mg (extended release) [Brand: Felodur ER 10 mg]

                           omit from the column headed “Responsible Person” (all instances): TX substitute (all instances): IY

[104]           Schedule 1, Part 1, entry for Felodipine in the form Tablet 10 mg (extended release) [Brand: Plendil ER]

                           omit from the column headed “Responsible Person” (all instances): GX substitute (all instances): IX

[105]           Schedule 1, Part 1, omit entries for Fluorometholone

[106]           Schedule 1, Part 1, entry for Folinic acid

                           omit:

Folinic acid

Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL

Injection

Leucovorin Calcium (Pfizer Australia Pty Ltd)

PF

MP

 

 

10

1

 

10

 

 


[107]           Schedule 1, Part 1, entry for Gilteritinib in the form Tablet 40 mg (as fumarate) [Maximum Quantity: 84; Number of Repeats: 0]

(a)           omit from the column headed “Circumstances”: C13166 substitute: C15526

(b)           omit from the column headed “Purposes”: P13166  substitute: P15526

[108]           Schedule 1, Part 1, entry for Gilteritinib in the form Tablet 40 mg (as fumarate) [Maximum Quantity: 84; Number of Repeats: 4]

(a)           omit from the column headed “Circumstances”: C13242 substitute: C15466

(b)           omit from the column headed “Purposes”: P13242  substitute: P15466

[109]           Schedule 1, Part 1, omit entry for Glucose indicator-urine

[110]           Schedule 1, Part 1, entry for Insulin neutral with insulin isophane in the form Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5

                           omit:

Insulin neutral with insulin isophane

Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5

Injection

Mixtard 30/70 InnoLet

NI

MP NP

 

 

5

1

 

1

 

 

[111]           Schedule 1, Part 1, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30

                           omit:

Ipratropium

Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30

Inhalation

Aeron 250

AL

MP NP

C6331 C6341

 

2

5

 

1

 

 

[112]           Schedule 1, Part 1, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30

                           omit:

Ipratropium

Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30

Inhalation

Aeron 500

AL

MP NP

C6331 C6341

 

2

5

 

1

 

 

[113]           Schedule 1, Part 1, entry for Larotrectinib

                           substitute:

Larotrectinib

Capsule 25 mg (as sulfate)

Oral

Vitrakvi

BN

MP

C12981 C12982 C15467

P12981 P12982 P15467

56

2

 

56

 

 

Larotrectinib

Capsule 25 mg (as sulfate)

Oral

Vitrakvi

BN

MP

C12980 C15509

P12980 P15509

56

5

 

56

 

 

Larotrectinib

Capsule 100 mg (as sulfate)

Oral

Vitrakvi

BN

MP

C12981 C12982 C15467

P12981 P12982 P15467

56

2

 

56

 

 

Larotrectinib

Capsule 100 mg (as sulfate)

Oral

Vitrakvi

BN

MP

C12980 C15509

P12980 P15509

56

5

 

56

 

 

Larotrectinib

Oral solution 20 mg per mL (as sulfate), 50 mL, 2

Oral

Vitrakvi

BN

MP

C12981 C12982 C15467

P12981 P12982 P15467

1

2

 

1

 

 

Larotrectinib

Oral solution 20 mg per mL (as sulfate), 50 mL, 2

Oral

Vitrakvi

BN

MP

C12980 C15509

P12980 P15509

1

5

 

1

 

 

[114]           Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

(a)           omit from the column headed “Circumstances”: C6604

(b)           insert in numerical order in the column headed “Circumstances”: C15510

(c)           omit from the column headed “Purposes”: P6604

(d)           insert in numerical order in the column headed “Purposes”: P15510

[115]           Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 10 mg (as mesilate)

(a)           omit from the column headed “Circumstances”: C6604

(b)           insert in numerical order in the column headed “Circumstances”: C15510

[116]           Schedule 1, Part 1, entry for Mepolizumab

                           omit:

Mepolizumab

Powder for injection 100 mg

Injection

Nucala

GK

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

[117]           Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

                           omit:

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

Blooms the Chemist Metformin XR 500

IB

MP NP

 

 

120

5

 

120

 

 

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

Blooms the Chemist Metformin XR 500

IB

MP NP

 

P14238

240

5

 

120

 

 

[118]           Schedule 1, Part 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

                           omit:

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

Blooms the Chemist Metformin XR 1000

IB

MP NP

 

 

60

5

 

60

 

 

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

Blooms the Chemist Metformin XR 1000

IB

MP NP

 

P14238

120

5

 

60

 

 

[119]           Schedule 1, Part 1, entry for Methotrexate

                           substitute:

Methotrexate

Injection 5 mg in 2 mL vial

Injection

DBL Methotrexate

PF

MP NP

 

 

5

0

 

5

 

 

Methotrexate

Injection 7.5 mg in 0.15 mL pre-filled syringe

Injection

Trexject

LM

MP NP

C7488 C7518

 

4

5

 

1

 

 

Methotrexate

Injection 7.5 mg in 0.15 mL pre-filled syringe

Injection

Trexject

LM

MP

C15068

 

4

5

 

1

 

 

Methotrexate

Injection 10 mg in 0.2 mL pre-filled syringe

Injection

Trexject

LM

MP NP

C7488 C7518

 

4

5

 

1

 

 

Methotrexate

Injection 10 mg in 0.2 mL pre-filled syringe

Injection

Trexject

LM

MP

C15068

 

4

5

 

1

 

 

Methotrexate

Injection 15 mg in 0.3 mL pre-filled syringe

Injection

Trexject

LM

MP NP

C7488 C7518

 

4

5

 

1

 

 

Methotrexate

Injection 15 mg in 0.3 mL pre-filled syringe

Injection

Trexject

LM

MP

C15068

 

4

5

 

1

 

 

Methotrexate

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Trexject

LM

MP NP

C7488 C7518

 

4

5

 

1

 

 

Methotrexate

Injection 20 mg in 0.4 mL pre-filled syringe

Injection

Trexject

LM

MP

C15068

 

4

5

 

1

 

 

Methotrexate

Injection 25 mg in 0.5 mL pre-filled syringe

Injection

Trexject

LM

MP NP

C7488 C7518

 

4

5

 

1

 

 

Methotrexate

Injection 25 mg in 0.5 mL pre-filled syringe

Injection

Trexject

LM

MP

C15068

 

4

5

 

1

 

 

Methotrexate

Injection 50 mg in 2 mL vial

Injection

DBL Methotrexate

PF

MP NP

 

 

5

5

 

5

 

 

Methotrexate

Injection 50 mg in 2 mL vial

Injection

DBL Methotrexate

PF

MP

 

P14238

10

5

 

5

 

 

Methotrexate

Solution concentrate for I.V. infusion 500 mg in 20 mL vial

Injection

DBL Methotrexate

PF

MP

 

P6276

See Note 3

See Note 3

 

1

 

PB(100)

Methotrexate

Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

Injection

DBL Methotrexate

PF

MP

 

P6276

See Note 3

See Note 3

 

1

 

PB(100)

Methotrexate

Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

Injection

Methotrexate Accord

OD

MP

 

P6276

See Note 3

See Note 3

 

1

 

PB(100)

Methotrexate

Solution concentrate for I.V. infusion 5000 mg in 50 mL vial

Injection

Methotrexate Ebewe

SZ

MP

 

P6276

See Note 3

See Note 3

 

1

 

PB(100)

Methotrexate

Tablet 2.5 mg

Oral

ARX-Methotrexate

XT

MP NP

 

 

30

5

 

30

 

 

Methotrexate

Tablet 2.5 mg

Oral

Chexate

OX

MP NP

 

 

30

5

 

30

 

 

Methotrexate

Tablet 2.5 mg

Oral

Methoblastin

PF

MP NP

 

 

30

5

 

30

 

 

Methotrexate

Tablet 10 mg

Oral

ARX-Methotrexate

XT

MP NP

 

 

15

3

 

15

 

 

Methotrexate

Tablet 10 mg

Oral

ARX-Methotrexate

XT

MP NP

 

P5648

50

2

 

50

 

 

Methotrexate

Tablet 10 mg

Oral

Chexate

OX

MP NP

 

 

15

3

 

15

 

 

Methotrexate

Tablet 10 mg

Oral

Chexate

OX

MP NP

 

P5648

50

2

 

50

 

 

Methotrexate

Tablet 10 mg

Oral

Methoblastin

PF

MP NP

 

 

15

3

 

15

 

 

Methotrexate

Tablet 10 mg

Oral

Methoblastin

PF

MP NP

 

P5648

50

2

 

50

 

 

[120]           Schedule 1, Part 1, entry for Metoclopramide

                           substitute:

Metoclopramide

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

Metoclopramide HCI Medsurge

DZ

MP NP MW PDP

 

 

10

0

 

10

 

 

Metoclopramide

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

Metoclopramide HCI Medsurge

DZ

MP NP

 

P6084

40
CN6084

2
CN6084

 

10

 

 

Metoclopramide

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

METOCLOPRAMIDE INJECTION BP

WZ

MP NP MW PDP

 

 

10

0

 

10

 

 

Metoclopramide

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

METOCLOPRAMIDE INJECTION BP

WZ

MP NP

 

P6084

40
CN6084

2
CN6084

 

10

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

APO-Metoclopramide

TX

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

APO-Metoclopramide

TX

MP NP

 

 

100

5

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

EMEXLON

RW

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

EMEXLON

RW

MP NP

 

 

100

5

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Maxolon

IL

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Maxolon

IL

MP NP

 

 

100

5

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Pramin

AF

MP NP MW PDP

 

 

25

0

 

25

 

 

Metoclopramide

Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)

Oral

Pramin

AF

MP NP

 

 

100

5

 

25

 

 

[121]           Schedule 1, Part 1, entry for Midazolam

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

[122]           Schedule 1, Part 1, after entry for Midazolam

                           insert:

Midazolam

Oromucosal solution (as maleate) 5 mg in 0.5 mL single use pre-filled oral syringe

Buccal

Zyamis

IX

MP NP

C15456

 

2

1

V15456

1

 

 

Midazolam

Oromucosal solution (as maleate) 5 mg in 0.5 mL single use pre-filled oral syringe

Buccal

Zyamis

IX

MP

C15457

 

2

1

V15457

1

 

 

Midazolam

Oromucosal solution (as maleate) 7.5 mg in 0.75 mL single use pre-filled oral syringe

Buccal

Zyamis

IX

MP NP

C15456

 

2

1

V15456

1

 

 

Midazolam

Oromucosal solution (as maleate) 7.5 mg in 0.75 mL single use pre-filled oral syringe

Buccal

Zyamis

IX

MP

C15457

 

2

1

V15457

1

 

 

Midazolam

Oromucosal solution (as maleate) 10 mg in 1 mL single use pre-filled oral syringe

Buccal

Zyamis

IX

MP NP

C15456

 

2

1

V15456

1

 

 

Midazolam

Oromucosal solution (as maleate) 10 mg in 1 mL single use pre-filled oral syringe

Buccal

Zyamis

IX

MP

C15457

 

2

1

V15457

1

 

 

[123]           Schedule 1, Part 1, entry for Mitozantrone

                           omit:

Mitozantrone

Injection 25 mg (as hydrochloride) in 12.5 mL

Injection

Onkotrone

BX

MP

 

 

See Note 3

See Note 3

 

1

 

D(100)

[124]           Schedule 1, Part 1, after entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium) [Brand: Montelukast Sandoz 4]

                           insert:

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

Montelukast Viatris

AL

MP NP

C6666

 

28

5

 

28

 

 

[125]           Schedule 1, Part 1, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg

                           omit:

Mycophenolic acid

Capsule containing mycophenolate mofetil 250 mg

Oral

CellCept

RO

MP

 

 

300

5

 

100

 

 

Mycophenolic acid

Capsule containing mycophenolate mofetil 250 mg

Oral

CellCept

RO

MP

 

P14238

600

5

 

100

 

 

[126]           Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg

                           omit:

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

CellCept

RO

MP

 

 

150

5

 

50

 

 

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

CellCept

RO

MP

 

P14238

300

5

 

50

 

 

[127]           Schedule 1, Part 1, entry for Niraparib

                           omit:

Niraparib

Capsule 100 mg (as tosilate monohydrate)

Oral

Zejula

GK

MP

C15230 C15239

P15230 P15239

56

2

 

56

 

 

Niraparib

Capsule 100 mg (as tosilate monohydrate)

Oral

Zejula

GK

MP

C15160 C15203

P15160 P15203

56

5

 

56

 

 

Niraparib

Capsule 100 mg (as tosilate monohydrate)

Oral

Zejula

GK

MP

C15108 C15162

P15108 P15162

84

2

 

84

 

 

Niraparib

Capsule 100 mg (as tosilate monohydrate)

Oral

Zejula

GK

MP

C15155 C15181

P15155 P15181

84

5

 

84

 

 

[128]           Schedule 1, Part 1, entry for Nivolumab

                           substitute:

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

BQ

MP

C9216 C9252 C9298 C9299 C9312 C9321 C10119 C10120 C11468 C11477 C11985 C13433 C13445 C13839 C13900 C14001 C14676 C14816 C14830 C15471 C15527

 

See Note 3

See Note 3

 

1

 

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

BQ

MP

C9216 C9252 C9298 C9299 C9312 C9321 C10119 C10120 C11468 C11477 C11985 C13433 C13445 C13839 C13900 C14001 C14676 C14816 C14830 C15471 C15527

 

See Note 3

See Note 3

 

1

 

D(100)

[129]           Schedule 1, Part 1, omit entry for Oxprenolol

[130]           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

Oxycodone BNM

BZ

PDP

C10768

P10768

20

0

 

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

Oxycodone BNM

BZ

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

OxyNorm

MF

MP NP PDP

C10766

P10766

10

0

 

10

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

OxyNorm

MF

PDP

C10768

P10768

20

0

 

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 5 mg

Oral

OxyNorm

MF

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 


[131]           Schedule 1, Part 1, entry for Oxycodone in the form Capsule containing oxycodone hydrochloride 10 mg

                           substitute:

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

Oxycodone BNM

BZ

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

Oxycodone BNM

BZ

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

Oxycodone BNM

BZ

PDP

C10768

P10768

20

0

 

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

OxyNorm

MF

MP NP PDP

C10766

P10766

10

0

 

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

OxyNorm

MF

MP NP

C10764 C10771 C10772

P10764 P10771 P10772

20

0

V10764 V10771 V10772

20

 

 

Oxycodone

Capsule containing oxycodone hydrochloride 10 mg

Oral

OxyNorm

MF

PDP

C10768

P10768

20

0

 

20

 

 

[132]           Schedule 1, Part 1, entry for Oxycodone in the form Capsule containing oxycodone hydrochloride 20 mg

                           insert as first entry:

Oxycodone

Capsule containing oxycodone hydrochloride 20 mg

Oral

Oxycodone BNM

BZ

MP NP

C10764 C10771 C10772

 

20

0

V10764 V10771 V10772

20

 

 

[133]           Schedule 1, Part 1, after entry for Patiromer in the form Powder for oral suspension 16.8 g [Authorised Prescriber: MP; Maximum Quantity: 30; Number of Repeats: 5]

                           insert:

Patisiran

Solution concentrate for I.V. infusion 10 mg in 5 mL

Injection

Onpattro

WM

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

1

 

D(100)

[134]           Schedule 1, Part 1, after entry for Permethrin

                           insert:

Permethrin

Cream 50 mg per g, 60 g (S19A)

Application

Permethrin Cream 5% w/w (Encube Ethicals, USA)

RQ

MP NP

 

 

1

0

 

1

 

 

[135]           Schedule 1, Part 1, entry for Pregabalin in the form Capsule 25 mg

                           omit:

Pregabalin

Capsule 25 mg

Oral

Cipla Pregabalin

LR

MP NP

C4172

 

56

5

 

56

 

 

[136]           Schedule 1, Part 1, entry for Pregabalin in the form Capsule 75 mg

                           omit:

Pregabalin

Capsule 75 mg

Oral

Cipla Pregabalin

LR

MP NP

C4172

 

56

5

 

56

 

 

[137]           Schedule 1, Part 1, entry for Pregabalin in the form Capsule 300 mg

                           omit:

Pregabalin

Capsule 300 mg

Oral

Cipla Pregabalin

LR

MP NP

C4172

 

56

5

 

56

 

 

[138]           Schedule 1, Part 1, entry for Protein hydrolysate formula with medium chain triglycerides

                           omit:

Protein hydrolysate formula with medium chain triglycerides

Oral powder 400 g (Alfaré)

Oral

Alfaré

NT

MP NP

C6137 C6138 C6148 C6157 C6158 C6166 C6174 C6182 C6193 C6194 C6195 C6204 C6205 C6206

 

8

5

 

1

 

 

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

                           substitute:

Quetiapine

Tablet (modified release) 50 mg (as fumarate)

Oral

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 50 mg (as fumarate)

Oral

QUETIAPINE-AS XR

RW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 50 mg (as fumarate)

Oral

Quetiapine Sandoz XR

SZ

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 50 mg (as fumarate)

Oral

Quetia XR

OW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 50 mg (as fumarate)

Oral

Seroquel XR

AL

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 50 mg (as fumarate)

Oral

Tevatiapine XR

TB

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

[140]           Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 200 mg (as fumarate)

                           substitute:

Quetiapine

Tablet (modified release) 200 mg (as fumarate)

Oral

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 200 mg (as fumarate)

Oral

QUETIAPINE-AS XR

RW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 200 mg (as fumarate)

Oral

Quetiapine Sandoz XR

SZ

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 200 mg (as fumarate)

Oral

Quetia XR

OW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 200 mg (as fumarate)

Oral

Seroquel XR

AL

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 200 mg (as fumarate)

Oral

Tevatiapine XR

TB

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

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

                           substitute:

Quetiapine

Tablet (modified release) 300 mg (as fumarate)

Oral

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 300 mg (as fumarate)

Oral

QUETIAPINE-AS XR

RW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 300 mg (as fumarate)

Oral

Quetiapine Sandoz XR

SZ

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 300 mg (as fumarate)

Oral

Quetia XR

OW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 300 mg (as fumarate)

Oral

Seroquel XR

AL

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 300 mg (as fumarate)

Oral

Tevatiapine XR

TB

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

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

                           substitute:

Quetiapine

Tablet (modified release) 400 mg (as fumarate)

Oral

APX-Quetiapine XR

TY

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 400 mg (as fumarate)

Oral

QUETIAPINE-AS XR

RW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 400 mg (as fumarate)

Oral

Quetiapine Sandoz XR

SZ

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 400 mg (as fumarate)

Oral

Quetia XR

OW

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 400 mg (as fumarate)

Oral

Seroquel XR

AL

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

Quetiapine

Tablet (modified release) 400 mg (as fumarate)

Oral

Tevatiapine XR

TB

MP NP

C4246 C5611 C5639

 

60

5

 

60

 

 

[143]           Schedule 1, Part 1, after entry for Ramipril in the form Tablet 10 mg [Brand: Ramipril Sandoz; Maximum Quantity: 60; Number of Repeats: 5]

                           insert:

Ramipril

Tablet 10 mg

Oral

Ramipril Viatris

AL

MP NP

 

 

30

5

 

30

 

 

Ramipril

Tablet 10 mg

Oral

Ramipril Viatris

AL

MP NP

 

P14238

60

5

 

30

 

 

[144]           Schedule 1, Part 1, entry for Ribavirin

                           omit:

Ribavirin

Tablet 200 mg

Oral

Ibavyr

IX

MP NP

C5957

 

200

2

 

100

 

C(100)

[145]           Schedule 1, Part 1, entry for Risperidone in each of the forms: Tablet 3 mg; and Tablet 4 mg

                           omit from the column headed “Purposes” (all instances): P4246 P5907

[146]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg [Brand: APO-Roxithromycin; Maximum Quantity: 10; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 150 mg

Oral

APO-Roxithromycin

TX

PDP

 

 

10

0

 

10

 

 

[147]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg [Brand: APX-Roxithromycin; Maximum Quantity: 10; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 150 mg

Oral

APX-Roxithromycin

TY

PDP

 

 

10

0

 

10

 

 

[148]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg [Brand: Roxar 150; Maximum Quantity: 10; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 150 mg

Oral

Roxar 150

RW

PDP

 

 

10

0

 

10

 

 


[149]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 150 mg [Brand: Roxithromycin Sandoz; Maximum Quantity: 10; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 150 mg

Oral

Roxithromycin Sandoz

SZ

PDP

 

 

10

0

 

10

 

 

[150]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg [Brand: APO-Roxithromycin; Maximum Quantity: 5; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 300 mg

Oral

APO-Roxithromycin

TX

PDP

 

 

5

0

 

5

 

 

[151]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg [Brand: APX-Roxithromycin; Maximum Quantity: 5; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 300 mg

Oral

APX-Roxithromycin

TY

PDP

 

 

5

0

 

5

 

 

[152]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg [Brand: Roxar 300; Maximum Quantity: 5; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 300 mg

Oral

Roxar 300

RW

PDP

 

 

5

0

 

5

 

 

[153]           Schedule 1, Part 1, entry for Roxithromycin in the form Tablet 300 mg [Brand: Roxithromycin Sandoz; Maximum Quantity: 5; Number of Repeats: 0]

(a)           omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP PDP

(b)           omit:

Roxithromycin

Tablet 300 mg

Oral

Roxithromycin Sandoz

SZ

PDP

 

 

5

0

 

5

 

 

[154]           Schedule 1, Part 1, after entry for Selinexor in the form Tablet 20 mg [Pack Quantity: 32]

                           insert:

Selumetinib

Capsule 10 mg

Oral

Koselugo

XI

MP

C15477 C15490 C15491

 

60

5

 

60

 

 

Selumetinib

Capsule 25 mg

Oral

Koselugo

XI

MP

C15477 C15490 C15491

 

60

5

 

60

 

 

[155]           Schedule 1, Part 1, after entry for Sertraline in the form Tablet 50 mg (as hydrochloride) [Brand: APO-Sertraline]

                           insert:

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

Blooms The Chemist Sertraline

BG

MP NP

C4755 C6277 C6289

 

30

5

 

30

 

 

[156]           Schedule 1, Part 1, after entry for Sertraline in the form Tablet 100 mg (as hydrochloride) [Brand: APO-Sertraline]

                           insert:

Sertraline

Tablet 100 mg (as hydrochloride)

Oral

Blooms The Chemist Sertraline

BG

MP NP

C4755 C6277 C6289

 

30

5

 

30

 

 

[157]           Schedule 1, Part 1, entry for Sofosbuvir with velpatasvir

                           omit:

Sofosbuvir with velpatasvir

Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir

Oral

Epclusa

GI

MP NP

C5969

 

28

2

 

28

 

C(100)

[158]           Schedule 1, Part 1, after entry for Tadalafil in the form Tablet 20 mg [Brand: TADALIS 20]

                           insert:

Tadalafil

Tablet 20 mg

Oral

Tadalis 20

LR

MP

See Note 3

See Note 3

See Note 3

See Note 3

 

60

 

D(100)

[159]           Schedule 1, Part 1, omit entries for Tafluprost

[160]           Schedule 1, Part 1, entry for Tenofovir

                           substitute:

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Tenofovir APOTEX

TX

MP NP

C10362

P10362

60

2

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Tenofovir APOTEX

TX

MP NP

C6980 C6982 C6983 C6984 C6992 C6998

P6980 P6982 P6983 P6984 P6992 P6998

60

5

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

TENOFOVIR ARX

XT

MP NP

C10362

P10362

60

2

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

TENOFOVIR ARX

XT

MP NP

C6980 C6982 C6983 C6984 C6992 C6998

P6980 P6982 P6983 P6984 P6992 P6998

60

5

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Tenofovir Sandoz

SZ

MP NP

C10362

P10362

60

2

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Tenofovir Sandoz

SZ

MP NP

C6980 C6982 C6983 C6984 C6992 C6998

P6980 P6982 P6983 P6984 P6992 P6998

60

5

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Viread

GI

MP NP

C10362

P10362

60

2

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Viread

GI

MP NP

C6980 C6982 C6983 C6984 C6992 C6998

P6980 P6982 P6983 P6984 P6992 P6998

60

5

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Mylan

AF

MP NP

C10362

P10362

60

2

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Mylan

AF

MP NP

C6980 C6982 C6983 C6984 C6992 C6998

P6980 P6982 P6983 P6984 P6992 P6998

60

5

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Viatris

AL

MP NP

C10362

P10362

60

2

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Viatris

AL

MP NP

C6980 C6982 C6983 C6984 C6992 C6998

P6980 P6982 P6983 P6984 P6992 P6998

60

5

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil phosphate 291 mg

Oral

Tenofovir GH

GQ

MP NP

C10362

P10362

60

2

 

30

 

D(100)

Tenofovir

Tablet containing tenofovir disoproxil phosphate 291 mg

Oral

Tenofovir GH

GQ

MP NP

C6980 C6982 C6983 C6984 C6992 C6998

P6980 P6982 P6983 P6984 P6992 P6998

60

5

 

30

 

D(100)

[161]           Schedule 1, Part 1, after entry for Teriparatide in the form Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen [Brand: Terrosa]

                           insert:

Testosterone

I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL

Injection

Gonadron

RA

MP

C6324 C6910 C6919 C6933 C6934

 

1

1

 

1

 

 

[162]           Schedule 1, Part 1, after entry for Testosterone in the form I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL [Brand: Reandron 1000]

                           insert:

Testosterone

I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL

Injection

REJUNON 1000

JU

MP

C6324 C6910 C6919 C6933 C6934

 

1

1

 

1

 

 

[163]           Schedule 1, Part 1, entry for Timolol

                           substitute:

Timolol

Eye drops 5 mg (as maleate) per mL, 5 mL

Application to the eye

Timoptol

MF

MP AO

 

 

1

5

 

1

 

 

Timolol

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Timoptol XE

MF

MP AO

 

 

1

5

 

1

 

 

Timolol

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL (S19A)

Application to the eye

Timoptol XE 0.50% (South Africa)

LM

MP AO

 

 

1

5

 

1

 

 

[164]           Schedule 1, Part 1, entry for Valganciclovir

                           substitute:

Valganciclovir

Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL

Oral

Valcyte

PB

MP NP

C4980

 

11

5

 

1

 

D(100)

Valganciclovir

Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL

Oral

Valcyte

PB

MP

C4989 C9316

 

11

5

 

1

 

D(100)

Valganciclovir

Tablet 450 mg (as hydrochloride)

Oral

Valganciclovir Sandoz

SZ

MP NP

C4980

 

120

5

 

60

 

D(100)

Valganciclovir

Tablet 450 mg (as hydrochloride)

Oral

Valganciclovir Sandoz

SZ

MP

C4989 C9316

 

120

5

 

60

 

D(100)

Valganciclovir

Tablet 450 mg (as hydrochloride)

Oral

Valganciclovir Viatris

AL

MP NP

C4980

 

120

5

 

60

 

D(100)

Valganciclovir

Tablet 450 mg (as hydrochloride)

Oral

Valganciclovir Viatris

AL

MP

C4989 C9316

 

120

5

 

60

 

D(100)

[165]           Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

                           substitute:

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

APO-Zoledronic Acid

TX

MP

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

 

1

11

 

1

 

PB(100)

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

DEZTRON

DZ

MP

C14729 C14735

P14729 P14735

1

0

 

1

 

PB(100)

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

DEZTRON

DZ

MP

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328

1

11

 

1

 

PB(100)

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

Zoledronate-DRLA 4

RZ

MP

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

 

1

11

 

1

 

PB(100)

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

Zoledronic Acid Accord

OC

MP

C14729 C14735

P14729 P14735

1

0

 

1

 

PB(100)

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

Zoledronic Acid Accord

OC

MP

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328

1

11

 

1

 

PB(100)

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

Injection

Zometa

SA

MP

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328

 

1

11

 

1

 

PB(100)

[166]           Schedule 1, Part 2, after entry for Acalabrutinib

                           insert:

Alirocumab

Injection 75 mg in 1 mL single use pre‑filled pen

Injection

Praluent

SW

2

 

 

Alirocumab

Injection 150 mg in 1 mL single use pre‑filled pen

Injection

Praluent

SW

2

 

 

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

Oral powder 400 g (Alfamino)

Oral

Alfamino

NT

1

 

 

[167]           Schedule 1, Part 2, entry for Fluorometholone

                           substitute:

Fluorometholone

Eye drops 1 mg per mL, 5 mL

Application to the eye

FML Liquifilm

VE

1

 

 

[168]           Schedule 1, Part 2, after entry for Fluorometholone

                           insert:

Glucose indicator-urine

Test strips, 50 (Diastix)

For external use

Diastix

DX

1

 

 

[169]           Schedule 1, Part 2, after entry for Ketoconazole

                           insert:

Mepolizumab

Powder for injection 100 mg

Injection

Nucala

GK

1

 

 

Niraparib

Capsule 100 mg (as tosilate monohydrate)

Orald

Zejula

GK

56

 

 

Niraparib

Capsule 100 mg (as tosilate monohydrate)

Oral

Zejula

GK

84

 

 

Protein hydrolysate formula with medium chain triglycerides

Oral powder 400 g (Alfaré)

Oral

Alfaré

NT

1

 

 

[170]           Schedule 1, Part 2, omit entries for Raltegravir

[171]           Schedule 3

                           omit:

GG

Gem Pharma Pty Ltd

45 641 456 868

[172]           Schedule 4, Part 1, entry for Circumstances Code “C5533”

omit from the column headed “Listed Drug”: Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid
substitute: Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexaenoic acid

[173]           Schedule 4, Part 1, entry for Circumstances Code “C5534”

omit from the column headed “Listed Drug”: Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid
substitute: Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexaenoic acid


[174]           Schedule 4, Part 1, entry for Circumstances Code “C5571”

omit from the column headed “Listed Drug”: Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid
substitute: Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexaenoic acid

[175]           Schedule 4, Part 1, entry for Circumstances Code “C5852”

omit from the column headed “Listed Drug”: Glucose indicator-urine

[176]           Schedule 4, Part 1, omit entry for Circumstances Code “C6206”

[177]           Schedule 4, Part 1, omit entry for Circumstances Code “C6604”

[178]           Schedule 4, Part 1, omit entry for Circumstances Code “C10126”

[179]           Schedule 4, Part 1, entry for Circumstances Code “C12871”

                           omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

[180]           Schedule 4, Part 1, entry for Circumstances Code “C12872”

                           omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

[181]           Schedule 4, Part 1, omit entry for Circumstances Code “C13166”

[182]           Schedule 4, Part 1, omit entry for Circumstances Code “C13242”

[183]           Schedule 4, Part 1, omit entry for Circumstances Code “C13313”

[184]           Schedule 4, Part 1, omit entry for Circumstances Code “C15108”

[185]           Schedule 4, Part 1, omit entry for Circumstances Code “C15155”

[186]           Schedule 4, Part 1, omit entry for Circumstances Code “C15160”

[187]           Schedule 4, Part 1, omit entry for Circumstances Code “C15162”


[188]           Schedule 4, Part 1, entry for Circumstances Code “C15177”

omit from the column headed “Listed Drug”: Alirocumab

[189]           Schedule 4, Part 1, omit entry for Circumstances Code “C15181”

[190]           Schedule 4, Part 1, entry for Circumstances Code “C15201”

omit from the column headed “Listed Drug”: Alirocumab

[191]           Schedule 4, Part 1, omit entry for Circumstances Code “C15203”

[192]           Schedule 4, Part 1, omit entry for Circumstances Code “C15230”

[193]           Schedule 4, Part 1, omit entry for Circumstances Code “C15239”

[194]           Schedule 4, Part 1, omit entry for Circumstances Code “C15366”

[195]           Schedule 4, Part 1, omit entry for Circumstances Code “C15409”

[196]           Schedule 4, Part 1, after entry for Circumstances Code “C15443”

                           insert:

C15445

P15445

CN15445

Adalimumab

Vision threatening non-infectious uveitis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug 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 24 weeks under this restriction per authority application.

Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

An adequate response to treatment is defined as:

(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or

(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or

(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or

(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)

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 - Streamlined Authority Code 15445

C15446

P15446

CN15446

Adalimumab

Vision threatening non-infectious uveitis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must demonstrated or sustained an adequate response to treatment with this drug for this condition; AND

The treatment must not exceed 24 weeks under this restriction per authority application.

Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

An adequate response to treatment is defined as:

(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or

(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or

(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or

(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)

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

C15450

P15450

CN15450

Adalimumab

Vision threatening non-infectious uveitis

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2024; AND

Patient must have non-infectious uveitis that is vision threatening with the diagnosis confirmed by an ophthalmologist, rheumatologist, or immunologist; AND

Patient must have failed to achieve an adequate response to corticosteroid therapy in combination with at least 1 immunosuppressive agent prior to commencing non-PBS-subsidised treatment; OR

Patient must have flared when corticosteroid therapy was tapered to a dose of less than or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy prior to commencing non-PBS-subsidised treatment; OR

Patient must have failed to achieve an adequate response to prior conventional immunomodulatory therapy in patients for whom corticosteroids are not clinically appropriate prior to commencing non-PBS-subsidised treatment; OR

Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy prior to commencing non-PBS-subsidised treatment; AND

Patient must have demonstrated or sustained an adequate response to treatment with this drug for this condition if they have received more than 25 weeks of non-PBS-subsidised treatment; AND

The treatment must not exceed 24 weeks under this restriction.

Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

Vision threatening disease is defined as at least 1 of the following:

(a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;

(b) A 2-step increase in anterior chamber cells or vitreous haze;

(c) New retinal vasculitis;

(d) New retinal or choroidal lesions;

(e) Other signs of disease progression including visual field changes or electroretinogram changes

An adequate response to treatment is defined as:

(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or

(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or

(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or

(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)

Compliance with Authority Required procedures

C15454

P15454

CN15454

Cabozantinib

Locally advanced or metastatic differentiated thyroid cancer

Initial treatment

The condition must be refractory to radioactive iodine; OR

Patient must be deemed ineligible for treatment with radioactive iodine; AND

Patient must have progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) whilst on treatment with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) for this indication; OR

Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to prior VEGF-targeted TKI therapy; AND

Patient must have a WHO performance status of no higher than 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have thyroid stimulating hormone adequately suppressed.

Radioactive iodine refractory is defined as:

(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or

(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or

(iii) progression within 12 months of a single RAI treatment; or

(iv) progression after two RAI treatments administered within 12 months of each other.

Compliance with Authority Required procedures - Streamlined Authority Code 15454

C15455

P15455

CN15455

Atezolizumab

Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC)

1,875 mg administered once every 3 weeks

Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR

Patient must be continuing existing PBS-subsidised treatment with this drug; OR

Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated.

Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.

The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND

The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND

The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.

Compliance with Authority Required procedures - Streamlined Authority Code 15455

C15456

P15456

CN15456

Midazolam

Generalized convulsive status epilepticus

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

At the time of the authority application, practitioners should request the appropriate quantity to cater for the patient's circumstances.

Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.

Compliance with Authority Required procedures

C15457

P15457

CN15457

Midazolam

Generalized convulsive status epilepticus

Initial treatment

Patient must have been assessed to be at significant risk of status epilepticus; AND

Patient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency medical attention within the previous 5 years.

Patient must be at least one year of age.

The treatment must initiated by a specialist physician experienced in the treatment of epilepsy.

At the time of the authority application, medical practitioners should request the appropriate quantity to cater for the patient's circumstances.

Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.

Compliance with Authority Required procedures

C15466

P15466

CN15466

Gilteritinib

Relapsed or refractory Acute Myeloid Leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition; AND

The treatment must not be for maintenance therapy post-transplant.

Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.

If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.

Progressive disease is defined as the presence of any of the following:

(a) Leukaemic cells in the CSF; or

(b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or

(c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or

(d) Extramedullary leukaemia.

Compliance with Authority Required procedures

C15467

P15467

CN15467

Larotrectinib

Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion

Initial treatment

The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND

The condition must be non-small cell lung cancer confirmed through a pathology report from an Approved Pathology Authority (of any date); OR

The condition must be soft tissue sarcoma confirmed through a pathology report from an Approved Pathology Authority (of any date); OR

The condition must be confirmed through a pathology report from an Approved Pathology Authority (of any date) as either: (i) glioma, (ii) glioneuronal tumour, (iii) glioblastoma; AND

The condition must be metastatic disease; OR

The condition must be both: (i) locally advanced, (ii) unresectable; OR

The condition must be locally advanced where surgical resection is likely to result in severe morbidity; AND

Patient must have received prior systemic treatment for this disease; OR

Patient must have a condition that predisposes them to an unacceptable risk of intolerance to other systemic therapies; AND

The treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; AND

Patient must not receive more than 3 months of treatment under this restriction.

Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition.

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:

(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.

(b) details of the pathology report establishing the carcinoma type (non-small cell lung cancer, soft tissue sarcoma or either glioma/ glioneuronal tumour/ glioblastoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.

(c) details of prior systemic treatment for this disease or details of the condition that predisposes the patient to an unacceptable risk of intolerance to other systemic therapies.

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C15469

P15469

CN15469

Beclometasone with formoterol

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy; OR

Patient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.

Patient must be at least 18 years of age.

Compliance with Authority Required procedures - Streamlined Authority Code 15469

C15471

P15471

CN15471

Nivolumab

Resectable non-small cell lung cancer (NSCLC)

The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size; AND

The treatment must be for neoadjuvant use in a patient preparing for surgical resection; AND

Patient must have a WHO performance status of 0 or 1; AND

The treatment must be in combination with platinum-based chemotherapy.

Patient must not be undergoing treatment with more than 3 PBS-subsidised doses of this drug per lifetime for this indication.

In non-squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement.

Compliance with Authority Required procedures - Streamlined Authority Code 15471

C15473

P15473

CN15473

Adalimumab

Vision threatening non-infectious uveitis

Balance of Supply

Patient must have received PBS-subsidised treatment with this drug for this condition; AND

Patient must have received insufficient therapy with this drug for this condition to complete one of the following: (i) 25 weeks for initial treatment; (ii) 25 weeks for recommencement treatment; (iii) 24 weeks for continuing treatment; (iv) 24 weeks for transitioning from non-PBS to PBS-subsidised treatment.

Compliance with Authority Required procedures

C15474

P15474

CN15474

Adalimumab

Vision threatening non-infectious uveitis

Initial treatment

Patient must have non-infectious uveitis that is vision threatening with the diagnosis confirmed by an ophthalmologist, rheumatologist, or immunologist; AND

Patient must have failed to achieve an adequate response to corticosteroid therapy in combination with at least 1 immunosuppressive agent; OR

Patient must have flared when corticosteroid therapy was tapered to a dose of less than or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy; OR

Patient must have failed to achieve an adequate response to at least one immunosuppressive agent in patients for whom corticosteroids are not clinically appropriate; OR

Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy; AND

The treatment must not exceed 25 weeks under this restriction.

Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

Vision threatening disease is defined as at least 1 of the following:

(a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;

(b) A 2-step increase in anterior chamber cells or vitreous haze;

(c) New retinal vasculitis;

(d) New retinal or choroidal lesions;

(e) Other signs of disease progression including visual field changes or electroretinogram changes

A failure to achieve an adequate response is defined as failure to meet one or more of the below criteria:

(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or

(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or

(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or

(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)

Details of prior immunomodulatory agent and corticosteroid treatment, or details of contraindications or developed intolerances necessitating treatment withdrawal, must be documented in the patient's medical record.

The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include details of vision threatening disease.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C15477

P15477

CN15477

Selumetinib

Neurofibromatosis type 1

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must be tolerating treatment; AND

Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment with this drug.

Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.

At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

For the purpose of administering this restriction, adequate response is defined as:

1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug;

2. relevant imaging has not shown an increase in tumour size of 20% or more.

Compliance with Authority Required procedures

C15479

P15479

CN15479

Cabozantinib

Locally advanced or metastatic differentiated thyroid cancer

Continuing treatment

The condition must be refractory to radioactive iodine; OR

Patient must be deemed ineligible for treatment with radioactive iodine; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).

Compliance with Authority Required procedures - Streamlined Authority Code 15479

C15485

P15485

CN15485

Avelumab

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer

Maintenance therapy - Initial treatment

Patient must have received first-line platinum-based chemotherapy; AND

Patient must not have progressive disease following first-line platinum-based chemotherapy; AND

Patient must have a WHO performance status of 0 or 1; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 15485

C15489

P15489

CN15489

Adalimumab

Vision threatening non-infectious uveitis

Recommencement of treatment

Patient must have a documented history of non-infectious uveitis that is vision threatening; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated or sustained an adequate response to treatment prior to having a break in therapy with this drug for this condition; AND

The treatment must not exceed 25 weeks under this restriction.

Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.

An adequate response to treatment is defined as:

(a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or

(b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or

(c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or

(d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)

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

C15490

P15490

CN15490

Selumetinib

Neurofibromatosis type 1

Initial treatment

Patient must have plexiform neurofibroma(s) (PN) that is causing/likely to cause at least one of: (i) significant symptoms/morbidity, (ii) disability, (iii) disfigurement, (iv) impairment of normal body function; AND

Patient must have PN for which complete resection cannot be performed; AND

Patient must have either a: (i) Karnofsky, (ii) Lansky Performance Score of at least 70%.

Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.

Patient must be aged between 2 to 18 years; AND

Patient must be able to swallow the whole capsule form of this drug.

At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to:

1. head and neck PN that can compromise the airway or great vessels;

2. paraspinal PN that can cause myelopathy;

3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;

4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);

5. PN of the extremity that can cause limb hypertrophy or loss of function; and

6. painful PN.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C15491

P15491

CN15491

Selumetinib

Neurofibromatosis type 1

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have previously received treatment with this drug for this condition prior to 1 August 2024; OR

Patient must have previously received treatment with another mitogen-activated protein kinase (MEK) inhibitor for this condition prior to 1 August 2024; AND

Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply of a MEK inhibitor (including selumetinib) was commenced, the patient: (i) had PN that caused/was likely to cause at least one of: (a) significant symptoms/morbidity, (b) disability, (c) disfigurement, (d) impairment of normal body function; (ii) had PN for which complete PN resection could not be performed either: (a) safely, (b) without causing unacceptable morbidity; (iii) had either a: (a) Karnofsky, (b) Lansky Performance Score of at least 70%; (iv) was aged between 2 to 18 years; (v) was able to swallow the whole capsule form if received non-PBS supply with selumetinib; AND

Patient must be tolerating treatment; AND

Patient must have achieved either: (i) stabilisation of disease, (ii) adequate response to treatment, if have received at least 12 months of treatment.

Must be treated by a prescriber who is either: (i) a specialist physician with expertise in neurofibromatosis, (ii) a medical practitioner in consultation with a specialist physician with expertise in neurofibromatosis if attendance is not possible due to geographic isolation.

At the time of the authority application, medical practitioners must request the appropriate number of packs of appropriate strength(s) to provide sufficient drug, based on the body surface area (BSA) of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

For the purpose of administering this restriction, significant symptoms/morbidity are defined as, but not limited to:

1. head and neck PN that can compromise the airway or great vessels;

2. paraspinal PN that can cause myelopathy;

3. brachial or lumbar plexus PN that can cause nerve compression and loss of function;

4. PN that can result in major deformity or significant disfiguring (e.g. orbital PN);

5. PN of the extremity that can cause limb hypertrophy or loss of function; and

6. painful PN.

For the purpose of administering this restriction, adequate response is defined as:

1. stability or improvement of the initial baseline measurements prior to initiating treatment with this drug;

2. relevant imaging has not shown an increase in tumour size of 20% or more.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

C15500

P15500

CN15500

Durvalumab

Unresectable Stage III non-small cell lung cancer

Initial treatment

Patient must have received platinum based chemoradiation therapy; AND

The condition must not have progressed following platinum based chemoradiation therapy; AND

Patient must have a WHO performance status of 0 or 1; AND

Patient must be untreated with immunotherapy at commencement of this drug; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 15500

C15509

P15509

CN15509

Larotrectinib

Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be either: (i) non-small cell lung cancer, (ii) soft tissue sarcoma, (iii) glioma, (iv), glioneuronal tumour, (v) glioblastoma; AND

The treatment must cease to be a PBS benefit upon radiographic progression; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Patient must be at least 18 years of age.

Where radiographic progression is observed, mark any remaining repeat prescriptions with the word 'cancelled'.

Compliance with Authority Required procedures

C15510

P15510

CN15510

Lenvatinib

Locally advanced or metastatic differentiated thyroid cancer

Initial treatment

The condition must be refractory to radioactive iodine; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have symptomatic progressive disease prior to treatment; OR

Patient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures; AND

Patient must have thyroid stimulating hormone adequately suppressed; AND

Patient must be one in whom surgery is inappropriate; AND

Patient must not be a candidate for radiotherapy with curative intent; AND

Patient must have a WHO performance status of 2 or less.

Radioactive iodine refractory is defined as:

(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or

(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or

(iii) progression within 12 months of a single RAI treatment; or

(iv) progression after two RAI treatments administered within 12 months of each other.

Compliance with Authority Required procedures - Streamlined Authority Code 15510

C15518

P15518

CN15518

Cabozantinib

Locally advanced or metastatic differentiated thyroid cancer

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2024; AND

The condition must be refractory to radioactive iodine; OR

Patient must be deemed ineligible for treatment with radioactive iodine; AND

Patient must have had progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) whilst on treatment with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) prior to receiving this drug for this indication; OR

Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to prior VEGF-targeted TKI therapy prior to receiving this drug for this indication; AND

Patient must have had a WHO performance status of no greater than 2 prior to receiving this drug for this indication; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have thyroid stimulating hormone adequately suppressed.

Radioactive iodine refractory is defined as:

(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or

(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or

(iii) progression within 12 months of a single RAI treatment; or

(iv) progression after two RAI treatments administered within 12 months of each other.

Compliance with Authority Required procedures - Streamlined Authority Code 15518

C15526

P15526

CN15526

Gilteritinib

Relapsed or refractory Acute Myeloid Leukaemia

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The condition must not be acute promyelocytic leukaemia; AND

The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation; AND

The treatment must not be for maintenance therapy post-transplant.

The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.

Compliance with Authority Required procedures

C15527

P15527

CN15527

Nivolumab

Urothelial carcinoma

The treatment must be for each of: (i) adjuvant therapy that is/was initiated within 120 days of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2-ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS-subsidised anti-cancer treatment for this condition; AND

Patient must have received prior platinum containing neoadjuvant chemotherapy; AND

Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.

Patient must be undergoing treatment with a dosing regimen as set out in the drug's Therapeutic Goods Administration (TGA) approved Product Information; AND

Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.

An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.

Compliance with Authority Required procedures

[197]           Schedule 4, Part 2, after entry for Variation Code “V15303”

                           insert:

V15456

Midazolam

At the time of the authority application, practitioners should request the appropriate quantity to cater for the patient's circumstances.

Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.

V15457

Midazolam

At the time of the authority application, medical practitioners should request the appropriate quantity to cater for the patient's circumstances.

Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.

[198]           Schedule 5, entry for Acamprosate

omit from the column headed “Brand”: Acamprosate Mylan

[199]           Schedule 5, entry for Acarbose in the form Tablet 50 mg

                           omit from the column headed “Brand”: Acarbose Mylan

[200]           Schedule 5, entry for Aciclovir in the form Tablet 800 mg

                           insert in the column headed “Brand”, after entry for the Brand “APO-Aciclovir”: ARX-ACICLOVIR

[201]           Schedule 5, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [GRP-25059]

insert in alphabetical order in the column headed “Brand”: Abrilada

[202]           Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [GRP-25060]

insert in alphabetical order in the column headed “Brand”: Abrilada

[203]           Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [GRP-25058]

insert in alphabetical order in the column headed “Brand”: Abrilada

[204]           Schedule 5, entry for Allopurinol in the form Tablet 100 mg

                           insert in the column headed “Brand”, after entry for the Brand “Allosig”: APO-ALLOPURINOL

[205]           Schedule 5, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

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

[206]           Schedule 5, entry for Bosentan in the form Tablet 125 mg (as monohydrate)

                           omit from the column headed “Brand”: Bosentan Cipla

[207]           Schedule 5, omit entry for Cefazolin

[208]           Schedule 5, omit entries for Cefepime

[209]           Schedule 5, omit entries for Ceftriaxone

[210]           Schedule 5, entry for Cinacalcet in the form Tablet 90 mg (as hydrochloride)

                           omit from the column headed “Brand”: Cinacalcet Mylan

[211]           Schedule 5, entry for Dabigatran etexilate in the form Capsule 75 mg (as mesilate)

                           omit from the column headed “Brand”: PHARMACOR DABIGATRAN

[212]           Schedule 5, entry for Dasatinib in each of the forms: Tablet 100 mg; Tablet 20 mg; Tablet 50 mg; and Tablet 70 mg

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

[213]           Schedule 5, entry for Ezetimibe

                           omit from the column headed “Brand”: Blooms The Chemist Ezetimibe

[214]           Schedule 5, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 250 micrograms (as monohydrate) in 1 mL single dose units, 30

                           omit from the column headed “Brand”: Aeron 250

[215]           Schedule 5, entry for Ipratropium in the form Nebuliser solution containing ipratropium bromide 500 micrograms (as monohydrate) in 1 mL single dose units, 30

                           omit from the column headed “Brand”: Aeron 500

[216]           Schedule 5, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

                           omit from the column headed “Brand”: Blooms the Chemist Metformin XR 1000

[217]           Schedule 5, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg

                           omit from the column headed “Brand”: Blooms the Chemist Metformin XR 500

[218]           Schedule 5, after entry for Methylprednisolone in the form Powder for injection 40 mg (as sodium succinate) with diluent

                           insert:

Metoclopramide

GRP-28223

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

Metoclopramide HCI Medsurge
METOCLOPRAMIDE INJECTION BP


[219]           Schedule 5, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

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

[220]           Schedule 5, entry for Mycophenolic acid in the form Capsule containing mycophenolate mofetil 250 mg

                           omit from the column headed “Brand”: CellCept

[221]           Schedule 5, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg

                           omit from the column headed “Brand”: CellCept

[222]           Schedule 5, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [GRP-19791]

                           substitute:

Ondansetron

GRP-19791

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron
APX-Ondansetron
Ondansetron-DRLA
Ondansetron Mylan Tablets
Ondansetron SZ
Ondansetron Tablets Viatris
Zofran
Zotren 4

[223]           Schedule 5, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [GRP-19626]

substitute:

Ondansetron

GRP-19626

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron
APX-Ondansetron
Ondansetron-DRLA
Ondansetron Mylan Tablets
Ondansetron SZ
Ondansetron Tablets Viatris
Zofran
Zotren 8

[224]           Schedule 5, after entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release) [GRP-19609]

                           insert:

Oxycodone

GRP-23062

Capsule containing oxycodone hydrochloride 5 mg

Oral

Oxycodone BNM
OxyNorm

Oxycodone

GRP-23063

Capsule containing oxycodone hydrochloride 10 mg

Oral

Oxycodone BNM
OxyNorm

Oxycodone

GRP-23065

Capsule containing oxycodone hydrochloride 20 mg

Oral

Oxycodone BNM
OxyNorm

[225]           Schedule 5, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 300 mg; and Capsule 75 mg

                           omit from the column headed “Brand”: Cipla Pregabalin

[226]           Schedule 5, entry for Quetiapine in the form Tablet (modified release) 200 mg (as fumarate) [GRP-20702]

substitute:

Quetiapine

GRP-20702

Tablet (modified release) 200 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetiapine Sandoz XR
Quetia XR
Seroquel XR
Tevatiapine XR

[227]           Schedule 5, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate) [GRP-20713]

substitute:

Quetiapine

GRP-20713

Tablet (modified release) 300 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetiapine Sandoz XR
Quetia XR
Seroquel XR
Tevatiapine XR

[228]           Schedule 5, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate) [GRP-20726]

              substitute:

Quetiapine

GRP-20726

Tablet (modified release) 400 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetiapine Sandoz XR
Quetia XR
Seroquel XR
Tevatiapine XR

[229]           Schedule 5, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate) [GRP-20779]

substitute:

Quetiapine

GRP-20779

Tablet (modified release) 50 mg (as fumarate)

Oral

APX-Quetiapine XR
QUETIAPINE-AS XR
Quetiapine Sandoz XR
Quetia XR
Seroquel XR
Tevatiapine XR

[230]           Schedule 5, entry for Ramipril in the form Tablet 10 mg

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

[231]           Schedule 5, entry for Sertraline in each of the forms: Tablet 100 mg (as hydrochloride); and Tablet 50 mg (as hydrochloride)

insert in alphabetical order in the column headed “Brand”: Blooms The Chemist Sertraline

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

insert in alphabetical order in the column headed “Brand”: TENOFOVIR ARX

[233]           Schedule 5, entry for Testosterone

(a)           insert in alphabetical order in the column headed “Brand”: Gonadron

(b)           insert in alphabetical order in the column headed “Brand”: REJUNON 1000

[234]           Schedule 5, after entry for Tetrabenazine

                           insert:

Timolol

GRP-28880

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL

Application to the eye

Timoptol XE

Timolol

GRP-28880

Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL (S19A)

Application to the eye

Timoptol XE 0.50% (South Africa)

[235]           Schedule 5, entry for Valganciclovir

                           omit from the column headed “Brand”: VALGANCICLOVIR HETERO