National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023
(No. 2)
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 27 February 2023
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2012
(PB 71 of 2012). 2
(1) This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 2).
(2) This Instrument may also be cited as PB 11 of 2023.
Commencement information | ||
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | 1 March 2023 | 1 March 2023 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
[1] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen
substitute:
| Injection 40 mg in 0.4 mL pre-filled pen | Injection |
| Humira | VE | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 |
| C(100) |
|
|
|
| Yuflyma | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 |
| C(100) |
|
|
|
| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11713 | 2 | 0 | 2 |
|
|
|
|
|
| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11713 | 2 | 0 | 2 |
|
|
|
|
|
| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 | 2 | 2 | 2 |
|
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 | 2 | 2 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 | 2 | 3 | 2 |
|
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 | 2 | 3 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11107 P12155 P12212 P13556 P13607 P13612 P13683 | 2 | 4 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11107 P12155 P12212 P13556 P13607 P13612 P13683 | 2 | 4 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 | 2 | 5 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 | 2 | 5 | 2 |
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| MP | C11526 C12116 |
| 2 | 5 | 2 |
| C(100) |
|
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P12273 | 4 | 2 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P12273 | 4 | 2 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P12272 P12315 | 4 | 5 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11529 P12272 P12315 | 4 | 5 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 | 6 | 0 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 | 6 | 0 | 2 |
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[2] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe
substitute:
| Injection 40 mg in 0.4 mL pre-filled syringe | Injection |
| Humira | VE | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 |
| C(100) |
|
|
|
| Yuflyma | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 |
| C(100) |
|
|
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11713 | 2 | 0 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11713 | 2 | 0 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 | 2 | 2 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 | 2 | 2 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 | 2 | 3 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P8638 P9064 P9386 P11810 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 | 2 | 3 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11107 P12155 P12212 P13556 P13607 P13612 P13683 | 2 | 4 | 2 |
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| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11107 P12155 P12212 P13556 P13607 P13612 P13683 | 2 | 4 | 2 |
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| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 | 2 | 5 | 2 |
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|
|
| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 | 2 | 5 | 2 |
|
|
|
|
|
|
|
| MP | C11526 C12116 |
| 2 | 5 | 2 |
| C(100) |
|
|
|
| Humira | VE | MP | C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 | 6 | 0 | 2 |
|
|
|
|
|
| Yuflyma | EW | MP | C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 | P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 | 6 | 0 | 2 |
|
|
[3] Schedule 1, Part 1, entry for Chlorpromazine
omit:
| Tablet containing chlorpromazine hydrochloride 10 mg | Oral |
| Largactil | SW | MP NP |
|
| 100 | 5 | 100 |
|
|
[4] Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 30 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Cinacalcet Viatris | AL | MP NP | C10068 |
| 28 | 5 | 28 |
|
|
[5] Schedule 1, Part 1, entry for Cinacalcet in the form Tablet 30 mg (as hydrochloride) [Maximum Quantity: 56; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Cinacalcet Viatris | AL | MP | C10063 C10067 C10073 |
| 56 | 5 | 28 |
| C(100) |
[6] Schedule 1, Part 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit:
|
|
|
| Blooms the Chemist Clopidogrel | IB | MP NP |
|
| 28 | 5 | 28 |
|
|
[7] Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit:
|
|
|
| Epirube | TB | MP |
|
| See Note 3 | See Note 3 | 1 |
| D(100) |
[8] Schedule 1, Part 1, entry for Ipilimumab in each of the forms: Injection concentrate for I.V. infusion 50 mg in 10 mL; and Injection concentrate for I.V. infusion 200 mg in 40 mL
(a) omit from the column headed “Circumstances”: C10122
(b) insert in numerical order in the column headed “Circumstances”: C13841
[9] Schedule 1, Part 1, omit entry for Losartan
[10] Schedule 1, Part 1, entry for Nitrofurantoin in each of the forms: Capsule 50 mg; and Capsule 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | ARX-Nitrofurantoin | XT | MP NP MW |
|
| 30 | 1 | 30 |
|
|
[11] Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL
(a) omit from the column headed “Circumstances”: C9214
(b) omit from the column headed “Circumstances”: C10195
(c) insert in numerical order in the column headed “Circumstances”: C13839 C13852 C13853 C13863
[12] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Olamlo HCT 20/5/12.5 | AL | MP NP | C4311 |
| 30 | 5 | 30 |
|
|
[13] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Olamlo HCT 40/5/12.5 | AL | MP NP | C4311 |
| 30 | 5 | 30 |
|
|
[14] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Olamlo HCT 40/5/25 | AL | MP NP | C4311 |
| 30 | 5 | 30 |
|
|
[15] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Olamlo HCT 40/10/12.5 | AL | MP NP | C4311 |
| 30 | 5 | 30 |
|
|
[16] Schedule 1, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Olamlo HCT 40/10/25 | AL | MP NP | C4311 |
| 30 | 5 | 30 |
|
|
[17] Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [Maximum Quantity: 10; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Oxycodone Viatris | MQ | MP NP | C10764 C10766 C10771 C10772 | P10766 | 10 | 0 | 20 |
|
|
|
|
|
|
|
| PDP | C10766 C10768 | P10766 | 10 | 0 | 20 |
|
|
[18] Schedule 1, Part 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [Maximum Quantity: 20; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Oxycodone Viatris | MQ | MP NP | C10764 C10766 C10771 C10772 | P10764 P10771 P10772 | 20 | 0 | 20 |
|
|
|
|
|
|
|
| PDP | C10766 C10768 | P10768 | 20 | 0 | 20 |
|
|
[19] Schedule 1, Part 1, entry for Paclitaxel
omit:
| Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection |
| Paclitaxin | TB | MP |
|
| See Note 3 | See Note 3 | 1 |
| D(100) |
[20] Schedule 1, Part 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
omit:
|
|
|
| Paclitaxin | TB | MP |
|
| See Note 3 | See Note 3 | 1 |
| D(100) |
[21] Schedule 1, Part 1, entry for Paraffin in the form Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g
substitute:
| Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g | Application to the eye |
| Poly Visc | IQ | MP NP AO |
|
| 1 | 5 | 1 |
|
|
|
|
|
| Refresh Night Time | AG | MP NP AO |
|
| 1 | 5 | 1 |
|
|
|
|
|
| Poly Visc | IQ | MP |
| P4894 | 1 | 11 | 1 |
|
|
|
|
|
| Refresh Night Time | AG | MP |
| P4894 | 1 | 11 | 1 |
|
|
[22] Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)
omit:
|
|
|
| Tevatrexed | TB | MP |
|
| See Note 3 | See Note 3 | 1 |
| D(100) |
[23] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
|
| PERISYL | AL | MP NP |
|
| 30 | 5 | 30 |
|
|
[24] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
|
| PERISYL | AL | MP NP |
|
| 30 | 5 | 30 |
|
|
[25] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
|
| PERISYL | AL | MP NP |
|
| 30 | 5 | 30 |
|
|
[26] Schedule 1, Part 1, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
|
| PERISYL COMBI 4/1.25 | AL | MP NP | C4375 |
| 30 | 5 | 30 |
|
|
[27] Schedule 1, Part 1, entry for Piroxicam
substitute:
Piroxicam | Capsule 10 mg | Oral |
| APO-Piroxicam | TX | PDP | C6214 |
| 50 | 0 | 50 |
|
|
|
|
|
|
|
| MP NP | C6214 |
| 50 | 3 | 50 |
|
|
| Capsule 20 mg | Oral |
| APO-Piroxicam | TX | PDP | C6214 |
| 25 | 0 | 25 |
|
|
|
|
|
|
|
| MP NP | C6214 |
| 25 | 3 | 25 |
|
|
| Dispersible tablet 20 mg | Oral |
| Feldene-D | PF | PDP | C6214 |
| 25 | 0 | 25 |
|
|
|
|
|
|
|
| MP NP | C6214 |
| 25 | 3 | 25 |
|
|
[28] Schedule 1, Part 1, entry for Polyethylene glycol 400 with propylene glycol
omit:
| Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28 | Application to the eye |
| Systane | AQ | AO MP NP | C6172 |
| 2 | 5 | 1 |
|
|
[29] Schedule 1, Part 1, omit entry for Polyvinyl alcohol
[30] Schedule 1, Part 1, entry for Pregabalin in each of the forms: Capsule 25 mg; Capsule 75 mg; Capsule 150 mg; and Capsule 300 mg
omit:
|
|
| a | Pregabalin-Teva | TB | MP NP | C4172 |
| 56 | 5 | 56 |
|
|
[31] Schedule 1, Part 1, entry for Propranolol
omit:
| Tablet containing propranolol hydrochloride 160 mg | Oral |
| Deralin 160 | AF | MP NP |
|
| 50 | 5 | 50 |
|
|
[32] Schedule 1, Part 1, entry for Salbutamol
omit:
| Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) | Inhalation by mouth |
| Asmol CFC-free | AL | MP NP |
|
| 2 | 5 | 1 |
|
|
[33] Schedule 1, Part 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)
insert in the column headed “Schedule Equivalent” (all instances): a
[34] Schedule 1, Part 1, entry for Somatropin
omit:
| Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative) | Injection |
| Humatrope | LY | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12734 C12738 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364 |
| See Note 3 | See Note 3 | 1 |
| D(100) |
| Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative) | Injection |
| Humatrope | LY | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12734 C12738 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364 |
| See Note 3 | See Note 3 | 1 |
| D(100) |
| Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative) | Injection |
| Humatrope | LY | MP | C12703 C12704 C12711 C12712 C12722 C12723 C12725 C12726 C12731 C12734 C12738 C12758 C12760 C12765 C12769 C12770 C12771 C12774 C12775 C12779 C12780 C12784 C12785 C12803 C12831 C12832 C12834 C12835 C12858 C12860 C12866 C12884 C12906 C12907 C12922 C13288 C13309 C13346 C13350 C13352 C13353 C13355 C13356 C13359 C13360 C13363 C13364 |
| See Note 3 | See Note 3 | 1 |
| D(100) |
[35] Schedule 1, Part 1, entry for Zanubrutinib
omit from the column headed “Circumstances”: C12573
[36] Schedule 1, Part 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| a | Zoledronate-DRLA 4 | RZ | MP | C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 |
| 1 | 11 | 1 |
| PB(100) |
[37] Schedule 1, Part 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL
substitute:
| Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL | Injection | a | Aclasta | HX | MP | C5710 C6308 C6313 C6318 |
| 1 | 0 | 1 |
|
|
|
|
| a | Osteovan | SZ | MP | C5710 C6308 C6313 C6318 |
| 1 | 0 | 1 |
|
|
|
|
| a | Zoledasta | TX | MP | C5710 C6308 C6313 C6318 |
| 1 | 0 | 1 |
|
|
|
|
| a | Zoledronate-RDY 5 | RI | MP | C5710 C6308 C6313 C6318 |
| 1 | 0 | 1 |
|
|
|
|
| a | Zoledronic Acid SUN | RA | MP | C5710 C6308 C6313 C6318 |
| 1 | 0 | 1 |
|
|
[38] Schedule 1, Part 2, after entry for Certolizumab pegol in the form Solution for injection 200 mg in 1 mL pre‑filled pen
insert:
Chlorpromazine | Tablet containing chlorpromazine hydrochloride 10 mg | Oral |
| Largactil | SW | MP NP |
|
| 100 | 5 | 100 |
|
|
[39] Schedule 1, Part 2, after entry for Interferon beta-1a in the form Solution for injection 132 micrograms in 1.5 mL multidose cartridge
insert:
Losartan | Tablet containing losartan potassium 25 mg | Oral |
| Cozavan | AF | MP NP |
|
| 30 | 5 | 30 |
|
|
| Tablet containing losartan potassium 50 mg | Oral |
| Cozavan | AF | MP NP |
|
| 60 | 5 | 30 |
|
|
[40] Schedule 1, Part 2, after entry for Pindolol
insert:
Piroxicam
| Dispersible tablet 10 mg | Oral |
| Mobilis D-10 | AF | PDP | C6214 |
| 50 | 0 | 50 |
|
|
|
|
|
|
|
| MP NP | C6214 |
| 50 | 3 | 50 |
|
|
Polyethylene glycol 400 with propylene glycol | Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28 | Application to the eye |
| Systane | AQ | AO MP NP | C6172 |
| 2 | 5 | 1 |
|
|
Polyvinyl alcohol | Eye drops 14 mg per mL, 15 mL | Application to the eye | a | Liquifilm Tears | AG | MP | C6073 C6098 | P6073 | 1 | 5 | 1 |
|
|
|
|
|
|
|
| NP | C6073 |
| 1 | 5 | 1 |
|
|
|
|
|
|
|
| AO | C6120 |
| 1 | 5 | 1 |
|
|
|
|
| a | PVA Tears | PE | MP | C6073 C6098 | P6073 | 1 | 5 | 1 |
|
|
|
|
|
|
|
| NP | C6073 |
| 1 | 5 | 1 |
|
|
|
|
|
|
|
| AO | C6120 |
| 1 | 5 | 1 |
|
|
|
|
| a | Liquifilm Tears | AG | MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
|
|
|
|
| a | PVA Tears | PE | MP | C6073 C6098 | P6098 | 1 | 11 | 1 |
|
|
Propranolol | Tablet containing propranolol hydrochloride 160 mg | Oral |
| Deralin 160 | AF | MP NP |
|
| 50 | 5 | 50 |
|
|
[41] Schedule 1, Part 2, omit entry for Rituximab
[42] Schedule 3, details relevant to Responsible Person code GO
omit from the column headed “Responsible Person”: Mylan Health Pty Ltd substitute: Viatris Pty Ltd
[43] Schedule 3, details relevant to Responsible Person code GT
omit from the column headed “Responsible Person”: Mylan Health Pty Ltd substitute: Viatris Pty Ltd
[44] Schedule 4, Part 1, entry for Donepezil
(a) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10099”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
(b) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10100”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
[45] Schedule 4, Part 1, entry for Galantamine
(a) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10099”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
(b) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10100”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
[46] Schedule 4, Part 1, entry for Ipilimumab
(a) omit:
| C10122 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 10122 |
(b) omit from the column headed “Purposes Code” for the circumstance code “C11930”: P11930
(c) insert in numerical order after existing text:
| C13841 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 13841 |
[47] Schedule 4, Part 1, entry for Memantine
(a) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10098”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
(b) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10184”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
[48] Schedule 4, Part 1, entry for Nivolumab
(a) omit:
| C9214 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 9214 |
(b) omit:
| C10195 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 10195 |
(c) insert in numerical order after existing text:
| C13839 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 13839 |
| C13852 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 13852 |
| C13853 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 13853 |
| C13863 |
|
| Unresectable Stage III or Stage IV malignant melanoma | Compliance with Authority Required procedures - Streamlined Authority Code 13863 |
[49] Schedule 4, Part 1, omit entry for Rituximab
[50] Schedule 4, Part 1, entry for Rivastigmine
(a) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10099”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
(b) omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” for circumstances code “C10100”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures
[51] Schedule 4, Part 1, entry for Somatropin
(a) omit:
| C12734 |
|
| Short stature associated with chronic renal insufficiency | Compliance with Written Authority Required procedures |
(b) omit:
| C12835 |
|
| Short stature associated with chronic renal insufficiency | Compliance with Written Authority Required procedures |
(c) omit:
| C12906 |
|
| Short stature associated with chronic renal insufficiency | Compliance with Written Authority Required procedures |
| C12907 |
|
| Short stature associated with chronic renal insufficiency | Compliance with Written Authority Required procedures |
(d) omit:
| C12922 |
|
| Short stature associated with chronic renal insufficiency | Compliance with Written Authority Required procedures |
[52] Schedule 4, Part 1, entry for Zanubrutinib
omit:
| C12573 |
|
| Mantle cell lymphoma | Compliance with Authority Required procedures |
[53] Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [GRP-25058]
insert in alphabetical order in the column headed “Brand”: Yuflyma
[54] Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [GRP-25060]
insert in alphabetical order in the column headed “Brand”: Yuflyma
[55] Schedule 5, after entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [GRP-25060]
insert:
| GRP-27087 | Injection 40 mg in 0.4 mL pre-filled syringe | Injection | Yuflyma |
|
| Injection 40 mg in 0.8 mL pre-filled syringe | Injection | Amgevita |
| GRP-27088 | Injection 40 mg in 0.4 mL pre-filled pen | Injection | Yuflyma |
|
| Injection 40 mg in 0.8 mL pre-filled pen | Injection | Amgevita |
[56] Schedule 5, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit from the column headed “Brand”: Blooms the Chemist Clopidogrel
[57] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]
insert in alphabetical order in the column headed “Brand”: PERISYL
[58] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]
insert in alphabetical order in the column headed “Brand”: PERISYL
[59] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg [GRP-15965]
insert in alphabetical order in the column headed “Brand”: PERISYL
[60] Schedule 5, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in alphabetical order in the column headed “Brand”: PERISYL COMBI 4/1.25
[61] Schedule 5, entry for Salbutamol
omit:
| GRP-24211 | Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | Asmol CFC-free |
|
| Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) | Inhalation by mouth | Asmol CFC-Free with dose counter |