National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 6) (Cth)

Case

PB 54 of 2023

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023
(No. 6)

National Health Act 1953

I, SOUMYA SUDARSHAN, Assistant Secretary (Acting), 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               29 June 2023

SOUMYA SUDARSHAN

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

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

  1. Name

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2023 (No. 6).

(2)This Instrument may also be cited as PB 54 of 2023.

  1. 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 July 2023 1 July 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Note:          This table relates only to the provisions of this instrument as originally made.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.

  1. Authority

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

4       Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

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

  1. Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose autoinjector [Maximum Quantity: 4; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8746           

(b)insert in numerical order in the column headed “Circumstances”: C14142

(c)omit from the column headed “Purposes”: P8746    

(d)insert in numerical order in the column headed “Purposes”: P14142

  1. Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose autoinjector [Maximum Quantity: 4; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8746           

(b)insert in numerical order in the column headed “Circumstances”: C14142

  1. Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8746           

(b)insert in numerical order in the column headed “Circumstances”: C14142

(c)omit from the column headed “Purposes”: P8746    

(d)insert in numerical order in the column headed “Purposes”: P14142

  1. Schedule 1, Part 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8746         

(b)insert in numerical order in the column headed “Circumstances”: C14142

  1. Schedule 1, Part 1, after entry for Acalabrutinib in the form Capsule 100 mg

insert:

Tablet 100 mg Oral CALQUENCE AP MP C10652 C12481 C12495 C12500 56 5 56
  1. Schedule 1, Part 1, entry for Adalimumab

substitute:

Adalimumab Injection 20 mg in 0.2 mL pre-filled syringe Injection Humira VE MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
MP C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966 P11713 2 0 2
MP C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966 P9715 P11715 P11716 P11761 P11852 P11854 P11855 2 3 2
MP C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966 P11717 P11767 P11853 P11903 P11966 2 5 2
MP C14107 C14136 2 5 2 C(100)
Injection 20 mg in 0.4 mL pre-filled syringe Injection Amgevita XT MP See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
MP C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966 P11713 2 0 1
MP C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966 P9715 P11715 P11716 P11761 P11852 P11854 P11855 2 3 1
MP C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966 P11579 P11717 P11718 P11767 P11853 P11903 P11966 2 5 1
MP C14107 C14136 2 5 1 C(100)
Injection 40 mg in 0.4 mL pre-filled pen Injection Humira VE MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Yuflyma EW MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P12273 4 2 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P12273 4 2 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P12272 P12315 4 5 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11529 P12272 P12315 4 5 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 6 0 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 6 0 2
Injection 40 mg in 0.4 mL pre-filled syringe Injection Humira VE MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Yuflyma EW MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Humira VE MP C8638 C9064 C9386 C9715 C11107 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 6 0 2
Yuflyma EW MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 6 0 2
Injection 40 mg in 0.8 mL pre-filled pen Injection Amgevita XT MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Hadlima RF MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Hyrimoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Idacio PK MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P12273 4 2 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P12273 4 2 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P12273 4 2 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P12273 4 2 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11529 P12272 P12315 4 5 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11529 P12272 P12315 4 5 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11529 P12272 P12315 4 5 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11529 P12272 P12315 4 5 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 6 0 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 6 0 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 6 0 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336 P13602 P13609 6 0 2
Injection 40 mg in 0.8 mL pre-filled syringe Injection Amgevita XT MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Hadlima RF MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Hyrimoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Idacio PK MP See Note 3 See Note 3 See Note 3 See Note 3 2 C(100)
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11713 2 0 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 2 2 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P8638 P9064 P9386 P11861 P12131 P12174 P12194 P13550 P13599 P13606 P13648 P13650 P13681 P13682 P13694 P14058 2 3 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11107 P12155 P12212 P13556 P13607 P13612 P13683 2 4 2
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 2 5 2
MP C14107 C14136 2 5 2 C(100)
Amgevita XT MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 6 0 2
Hadlima RF MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 6 0 2
Hyrimoz SZ MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 6 0 2
Idacio PK MP C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11759 C11761 C11767 C11769 C11772 C11852 C11853 C11854 C11855 C11861 C11865 C11867 C11903 C11906 C11966 C12098 C12101 C12122 C12123 C12131 C12147 C12148 C12155 C12156 C12157 C12158 C12174 C12175 C12176 C12189 C12190 C12194 C12212 C12214 C12228 C12234 C12240 C13550 C13556 C13599 C13602 C13606 C13607 C13609 C13612 C13648 C13650 C13681 C13682 C13683 C13694 C14058 P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 6 0 2
Injection 80 mg in 0.8 mL pre-filled pen Injection Humira VE MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P12103 P12105 P12153 P12155 P12161 P12212 1 0 1
MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P12273 2 2 1
MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P12306 2 5 1
MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278 3 0 1
Injection 80 mg in 0.8 mL pre-filled syringe Injection Humira VE MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P12103 P12105 P12153 P12155 P12161 P12212 1 0 1
MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P12273 2 2 1
MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P12306 2 5 1
MP C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306 P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278 3 0 1
  1. Schedule 1, Part 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

omit:

a Alendronate plus D3-DRLA RZ MP NP C6307 C6315 C6320 4 5 4
  1. Schedule 1, Part 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

omit:

a Alendronate plus D3-DRLA RZ MP NP C6306 C6319 C6325 4 5 4
  1. Schedule 1, Part 1, after entry for Auranofin in the form Tablet 3 mg

insert:

Avatrombopag Tablet 20 mg Oral Doptelet ZO MP See Note 3 See Note 3 See Note 3 See Note 3 30 D(100)
  1. Schedule 1, Part 1, entry for Azacitidine

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

a Azacitidine Sandoz SZ MP See Note 3 See Note 3 See Note 3 See Note 3 1 D(100)
  1. Schedule 1, Part 1, entry for Azathioprine in the form Tablet 25 mg

omit:

a Azathioprine GH GQ MP NP 100 5 100
  1. Schedule 1, Part 1, entry for Baricitinib in the form Tablet 2 mg [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8750           

(b)insert in numerical order in the column headed “Circumstances”: C14184

(c)omit from the column headed “Purposes”: P8750    

(d)insert in numerical order in the column headed “Purposes”: P14184

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

(a)omit from the column headed “Circumstances”: C8750           

(b)insert in numerical order in the column headed “Circumstances”: C14184

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

(a)omit from the column headed “Circumstances”: C8750           

(b)insert in numerical order in the column headed “Circumstances”: C14184

(c)omit from the column headed “Purposes”: P8750    

(d)insert in numerical order in the column headed “Purposes”: P14184

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

(a)omit from the column headed “Circumstances”: C8750           

(b)insert in numerical order in the column headed “Circumstances”: C14184

  1. Schedule 1, Part 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

substitute:

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses Inhalation by mouth a BiResp Spiromax TB MP C7970 C10464 C10538 P10464 1 2 1
NP C7970 C10464 P10464 1 2 1
a DuoResp Spiromax EV MP C7970 C10464 C10538 P10464 1 2 1
NP C7970 C10464 P10464 1 2 1
a Rilast TURBUHALER 200/6 ZA MP C7970 C10464 C10538 P10464 1 2 1
NP C7970 C10464 P10464 1 2 1
a Symbicort Turbuhaler 200/6 AP MP C7970 C10464 C10538 P10464 1 2 1
NP C7970 C10464 P10464 1 2 1
a BiResp Spiromax TB MP C7970 C10464 C10538 P7970 P10538 1 5 1
NP C7970 C10464 P7970 1 5 1
a DuoResp Spiromax EV MP C7970 C10464 C10538 P7970 P10538 1 5 1
NP C7970 C10464 P7970 1 5 1
a Rilast TURBUHALER 200/6 ZA MP C7970 C10464 C10538 P7970 P10538 1 5 1
NP C7970 C10464 P7970 1 5 1
a Symbicort Turbuhaler 200/6 AP MP C7970 C10464 C10538 P7970 P10538 1 5 1
NP C7970 C10464 P7970 1 5 1
  1. Schedule 1, Part 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

substitute:

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses Inhalation by mouth a Rilast TURBUHALER 400/12 ZA MP NP C7979 C10121 2 5 1
a Symbicort TURBUHALER 400/12 AP MP NP C7979 C10121 2 5 1
a BiResp Spiromax TB MP NP C7979 C10121 2 5 2
a DuoResp Spiromax EV MP NP C7979 C10121 2 5 2
  1. Schedule 1, Part 1, omit entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2

  1. Schedule 1, Part 1, entry for Buprenorphine

substitute:

Buprenorphine Injection (modified release) 8 mg in 0.16 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C14075 4 2 1 PB(100)
Injection (modified release) 16 mg in 0.32 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C14075 4 2 1 PB(100)
Injection (modified release) 24 mg in 0.48 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C14075 4 2 1 PB(100)
Injection (modified release) 32 mg in 0.64 mL pre-filled syringe Injection Buvidal Weekly UR MP NP C14075 4 2 1 PB(100)
Injection (modified release) 64 mg in 0.18 mL pre-filled syringe Injection Buvidal Monthly UR MP NP C14139 1 2 1 PB(100)
Injection (modified release) 96 mg in 0.27 mL pre-filled syringe Injection Buvidal Monthly UR MP NP C14139 1 2 1 PB(100)
Injection (modified release) 100 mg in 0.5 mL pre-filled syringe Injection Sublocade IR MP NP C14138 1 2 1 PB(100)
Injection (modified release) 128 mg in 0.36 mL pre-filled syringe Injection Buvidal Monthly UR MP NP C14139 1 2 1 PB(100)
Injection (modified release) 160 mg in 0.45 mL pre-filled syringe Injection Buvidal Monthly UR MP NP C14139 1 2 1 PB(100)
Injection (modified release) 300 mg in 1.5 mL pre-filled syringe Injection Sublocade IR MP NP C14138 1 2 1 PB(100)
Transdermal patch 5 mg Transdermal a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
Transdermal patch 10 mg Transdermal a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
Transdermal patch 15 mg Transdermal a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
Transdermal patch 20 mg Transdermal a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
Transdermal patch 25 mg Transdermal a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
Transdermal patch 30 mg Transdermal a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
Transdermal patch 40 mg Transdermal a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P10748 P10752 P10755 2 0 2
a Bupredermal TX MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Buprenorphine Sandoz SZ MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
a Norspan MF MP NP C10748 C10752 C10755 C11753 P11753 4 0 2
Tablet (sublingual) 400 micrograms (as hydrochloride) Sublingual Subutex IR MP NP C14157 28 2 7 PB(100)
Tablet (sublingual) 2 mg (as hydrochloride) Sublingual Subutex IR MP NP C14157 84 2 7 PB(100)
Tablet (sublingual) 8 mg (as hydrochloride) Sublingual Subutex IR MP NP C14157 112 2 7 PB(100)
  1. Schedule 1, Part 1, entry for Buprenorphine with naloxone

substitute:

Buprenorphine with naloxone Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride) Sublingual Suboxone Film 2/0.5 IR MP NP C14074 84 2 28 D(100)
Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride) Sublingual Suboxone Film 8/2 IR MP NP C14074 112 2 28 D(100)
  1. Schedule 1, Part 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

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

a BTC Candesartan BG MP NP 30 5 30
  1. Schedule 1, Part 1, entry for Certolizumab pegol in the form Injection 200 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

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

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

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

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

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

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

(c)omit from the column headed “Purposes”: P8626    

(d)insert in numerical order in the column headed “Purposes”: P14113

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

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

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

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

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

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

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

(a)omit from the column headed “Circumstances”: C8626         

(b)insert in numerical order in the column headed “Circumstances”: C14113

(c)omit from the column headed “Purposes”: P8626    

(d)insert in numerical order in the column headed “Purposes”: P14113

  1. Schedule 1, Part 1, entry for Choriogonadotropin alfa

substitute:

Choriogonadotropin alfa Solution for injection 250 micrograms in 0.5 mL pre-filled pen Injection Ovidrel SG MP C14124 1 0 1 C(100)
MP C14096 1 5 1
  1. Schedule 1, Part 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)

omit from the column headed “Circumstances” for the brand “APO-Escitalopram”: C4755        substitute: C4690 C4703 C4755 C4756 C4757

  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate) 

(a)omit:

Esomeprazole Sandoz SZ MP C8774 C8775 C8776 C8780 C8827 C11310 P8774 P8775 30 1 30
NP C8774 C8775 C8776 C8780 C8827 P8774 P8775 30 1 30

(b)omit:

Esomeprazole SZ HX MP C8774 C8775 C8776 C8780 C8827 C11310 P8774 P8775 30 1 30
NP C8774 C8775 C8776 C8780 C8827 P8774 P8775 30 1 30

(c)omit:

Esomeprazole Sandoz SZ MP C8774 C8775 C8776 C8780 C8827 C11310 P8776 P8780 P8827 30 5 30
NP C8774 C8775 C8776 C8780 C8827 P8776 P8780 P8827 30 5 30

(d)omit:

Esomeprazole SZ HX MP C8774 C8775 C8776 C8780 C8827 C11310 P8776 P8780 P8827 30 5 30
NP C8774 C8775 C8776 C8780 C8827 P8776 P8780 P8827 30 5 30

(e)omit:

Esomeprazole Sandoz SZ MP C8774 C8775 C8776 C8780 C8827 C11310 P11310 60 5 30

(f)omit:

Esomeprazole SZ HX MP C8774 C8775 C8776 C8780 C8827 C11310 P11310 60 5 30
  1. Schedule 1, Part 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate)

(a)omit:

Esomeprazole Sandoz SZ MP C8777 C8778 C8902 C11370 P8902 30 1 30
NP C8777 C8778 C8902 P8902 30 1 30

(b)omit:

Esomeprazole SZ HX MP C8777 C8778 C8902 C11370 P8902 30 1 30
NP C8777 C8778 C8902 P8902 30 1 30

(c)omit:

Esomeprazole Sandoz SZ MP C8777 C8778 C8902 C11370 P8777 P8778 30 5 30
NP C8777 C8778 C8902 P8777 P8778 30 5 30

(d)omit:

Esomeprazole SZ HX MP C8777 C8778 C8902 C11370 P8777 P8778 30 5 30
NP C8777 C8778 C8902 P8777 P8778 30 5 30

(e)omit:

Esomeprazole Sandoz SZ MP C8777 C8778 C8902 C11370 P11370 60 5 30

(f)omit:

Esomeprazole SZ HX MP C8777 C8778 C8902 C11370 P11370 60 5 30
  1. Schedule 1, Part 1, entry for Etanercept

substitute:

Etanercept Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL Injection Enbrel PF MP See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
MP C14154 C14155 1 5 1 C(100)
MP C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P8638 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 2 3 1
MP C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554 2 5 1
Injection 50 mg in 1 mL single use auto-injector, 4 Injection Enbrel PF MP See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
Brenzys RF MP C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P8638 P9064 P9410 P9429 P11107 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 1 3 1
Enbrel PF MP C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P8638 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 1 3 1
Brenzys RF MP C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P7276 P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P8887 P8955 P9081 P9123 P9140 P9156 P9162 P9481 P9487 P9502 P9554 1 5 1
Enbrel PF MP C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554 1 5 1
MP C14154 C14155 1 5 1 C(100)
Injections 50 mg in 1 mL single use pre-filled syringes, 4 Injection Enbrel PF MP See Note 3 See Note 3 See Note 3 See Note 3 1 C(100)
Brenzys RF MP C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P8638 P9064 P9410 P9429 P11107 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 1 3 1
Enbrel PF MP C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P8638 P9064 P9386 P9388 P9410 P9429 P9473 P11107 P12164 P12260 P12261 P12262 P12265 P12266 P12287 P12289 P12327 P12434 P12457 P13532 P13533 P13535 P13537 P13538 P13539 P13540 P13542 P13593 P13598 P13646 P13647 P13707 P14108 1 3 1
Brenzys RF MP C7276 C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C8887 C8955 C9064 C9081 C9123 C9140 C9156 C9162 C9410 C9429 C9481 C9487 C9502 C9554 C11107 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P7276 P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P8887 P8955 P9081 P9123 P9140 P9156 P9162 P9481 P9487 P9502 P9554 1 5 1
Enbrel PF MP C7289 C8638 C8662 C8692 C8718 C8839 C8842 C8873 C8879 C9064 C9081 C9123 C9140 C9162 C9377 C9380 C9386 C9388 C9410 C9429 C9473 C9487 C9502 C9554 C11107 C12164 C12260 C12261 C12262 C12265 C12266 C12287 C12289 C12327 C12434 C12457 C13532 C13533 C13535 C13537 C13538 C13539 C13540 C13542 C13593 C13598 C13646 C13647 C13707 C14108 P7289 P8662 P8692 P8718 P8839 P8842 P8873 P8879 P9081 P9123 P9140 P9162 P9377 P9380 P9487 P9502 P9554 1 5 1
MP C14154 C14155 1 5 1 C(100)
  1. Schedule 1, Part 1, entry for Ezetimibe and rosuvastatin in each of the forms: Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium); Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium); and Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)

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

a Pharmacor Ezetimibe Rosuvastatin Composite Pack CR MP NP C7957 1 5 1
  1. Schedule 1, Part 1, after entry for Filgrastim in the form Injection 480 micrograms in 1.6 mL

insert:

Finerenone Tablet 10 mg Oral Kerendia BN MP NP C14097 28 5 28
Tablet 20 mg Oral Kerendia BN MP NP C14097 28 5 28
  1. Schedule 1, Part 1, entry for Fingolimod in the form Capsule 500 micrograms (as hydrochloride)

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

a FINGOLIS LR MP C10162 C10172 28 5 28
  1. Schedule 1, Part 1, entry for Fluticasone propionate in the form Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

omit from the column headed “Circumstances” (all instances): C13917  substitute (all instances): C14180

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

(a)omit from the column headed “Circumstances”: C8741         

(b)insert in numerical order in the column headed “Circumstances”: C14171

(c)omit from the column headed “Purposes”: P8741    

(d)insert in numerical order in the column headed “Purposes”: P14171

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

(a)omit from the column headed “Circumstances”: C8741         

(b)insert in numerical order in the column headed “Circumstances”: C14171

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

(a)omit from the column headed “Circumstances”: C8741         

(b)insert in numerical order in the column headed “Circumstances”: C14171

(c)omit from the column headed “Purposes”: P8741    

(d)insert in numerical order in the column headed “Purposes”: P14171

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

(a)omit from the column headed “Circumstances”: C8741         

(b)insert in numerical order in the column headed “Circumstances”: C14171

  1. Schedule 1, Part 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

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

a Noumed Irbesartan VO MP NP 30 5 30
  1. Schedule 1, Part 1, entry for Lamivudine with zidovudine

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

a Lamivudine/Zidovudine Viatris 150/300 AL MP NP C4454 C4512 120 5 60 D(100)
  1. Schedule 1, Part 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

omit:

a Lamotrigine Sandoz SZ MP NP C11081 56 5 56
  1. Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

omit:

a Sandoz Metformin HX MP NP 90 5 90
  1. Schedule 1, Part 1, entry for Methadone

substitute:

Methadone Injection containing methadone hydrochloride 10 mg in 1 mL Injection Physeptone AS MP NP C10745 C10747 C10751 C11696 P10745 P10747 P10751 5 0 5
MP NP C10745 C10747 C10751 C11696 P11696 120 0 5
Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL Oral a Aspen Methadone Syrup AS MP NP C14178 840 2 1000 PB(100)
a Biodone Forte MW MP NP C14178 840 2 1000 PB(100)
Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL Oral Aspen Methadone Syrup AS MP NP C4902 C4941 P4941 200 0 200
MP NP C4902 C4941 P4902 200 2 200
a Aspen Methadone Syrup AS MP NP C14178 840 2 200 C(100)
a Biodone Forte MW MP NP C14178 840 2 200 C(100)
Tablet containing methadone hydrochloride 10 mg Oral Physeptone AS MP NP C10745 C10747 C10751 C11696 P10745 P10747 P10751 20 0 20
MP NP C10745 C10747 C10751 C11696 P11696 120 0 20
  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 15 mg

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

a Blooms The Chemist Mirtazapine BG MP NP C5650 30 5 30
  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

omit:

a Mirtazapine Sandoz ODT 15 SZ MP NP C5650 30 5 30
  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg

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

a Blooms The Chemist Mirtazapine BG MP NP C5650 30 5 30
  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

omit:

a Mirtazapine Sandoz ODT 30 SZ MP NP C5650 30 5 30
  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg

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

a Blooms The Chemist Mirtazapine BG MP NP C5650 30 5 30
  1. Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

omit:

a Mirtazapine Sandoz ODT 45 SZ MP NP C5650 30 5 30
  1. Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir

(a)omit from the column headed “Circumstances”: C13765        

(b)omit from the column headed “Circumstances”: C13893

(c)insert in numerical order in the column headed “Circumstances”: C14187

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

substitute:

Capsule containing oxycodone hydrochloride 10 mg Oral OxyNorm MF MP NP C10764 C10766 C10771 C10772 P10766 10 0 20
PDP C10766 C10768 P10766 10 0 20
MP NP C10764 C10766 C10771 C10772 P10764 P10771 P10772 20 0 20
PDP C10766 C10768 P10768 20 0 20
  1. Schedule 1, Part 1, entry for Paroxetine

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

a Noumed Paroxetine VO MP NP C4755 C6277 C6636 30 5 30
  1. Schedule 1, Part 1, after entry for Pemetrexed in the form Powder for I.V. infusion 1 g (as disodium)

insert:

Solution concentrate for I.V. infusion 100 mg (as disodium) in 4 mL Injection Pemetrexed Ever Pharma IT MP See Note 3 See Note 3 1 D(100)
Solution concentrate for I.V. infusion 500 mg (as disodium) in 20mL Injection Pemetrexed Ever Pharma IT MP See Note 3 See Note 3 1 D(100)
Solution concentrate for I.V. infusion 1 g (as disodium) in 40 mL Injection Pemetrexed Ever Pharma IT MP See Note 3 See Note 3 1 D(100)
  1. Schedule 1, Part 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg

(a)omit:

a Pravastatin Sandoz SZ MP NP 30 5 30

(b)omit:

a Pravastatin Sandoz SZ MP P7598 30 11 30
  1. Schedule 1, Part 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)

omit:

Rizatriptan-AU DZ MP NP C5708 4 5 2
  1. Schedule 1, Part 1, entry for Telmisartan in the form Tablet 40 mg

omit:

a Telmisartan GH GQ MP NP 28 5 28
  1. Schedule 1, Part 1, entry for Tocilizumab

substitute:

Tocilizumab Concentrate for injection 80 mg in 4 mL Injection Actemra RO MP See Note 3 See Note 3 See Note 3 See Note 3 1 PB(100)
MP C14082 C14093 C14164 C14179 P14082 P14164 2 5 1 PB(100)
MP C14082 C14093 C14164 C14179 P14093 P14179 4 5 1 PB(100)
Concentrate for injection 200 mg in 10 mL Injection Actemra RO MP See Note 3 See Note 3 See Note 3 See Note 3 1 PB(100)
MP C14082 C14093 C14164 C14179 P14082 P14164 1 5 1 PB(100)
MP C14082 C14093 C14164 C14179 P14093 P14179 2 5 1 PB(100)
Concentrate for injection 400 mg in 20 mL Injection Actemra RO MP See Note 3 See Note 3 See Note 3 See Note 3 1 PB(100)
MP C14082 C14093 C14164 C14179 P14082 P14164 1 5 1 PB(100)
MP C14082 C14093 C14164 C14179 P14093 P14179 2 5 1 PB(100)
Injection 162 mg in 0.9 mL single use pre-filled pen Injection Actemra ACTPen RO MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P10560 4 0 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P9477 P12404 P14094 P14103 P14121 P14153 P14166 P14182 4 1 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P14084 P14104 P14150 4 2 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P8638 P9386 P9391 P9478 P11689 P11781 P12193 P12399 P12405 P14056 P14080 P14147 P14175 4 3 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P8627 P8633 P9380 P9553 P14088 P14174 4 5 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P9180 4 6 4
Injection 162 mg in 0.9 mL single use pre-filled syringe Injection Actemra Subcutaneous Injection RO MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P10560 4 0 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P9477 P12404 P14094 P14103 P14121 P14153 P14166 P14182 4 1 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P14084 P14104 P14150 4 2 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P8638 P9386 P9391 P9478 P11689 P11781 P12193 P12399 P12405 P14056 P14080 P14147 P14175 4 3 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P8627 P8633 P9380 P9553 P14088 P14174 4 5 4
MP C8627 C8633 C8638 C9180 C9380 C9386 C9391 C9477 C9478 C9553 C10560 C11689 C11781 C12193 C12399 C12404 C12405 C14056 C14080 C14084 C14088 C14094 C14103 C14104 C14121 C14147 C14150 C14153 C14166 C14174 C14175 C14182 P9180 4 6 4
  1. Schedule 1, Part 1, entry for Tofacitinib in the form Tablet 5 mg [Maximum Quantity: 56; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8750         

(b)insert in numerical order in the column headed “Circumstances”: C14185

(c)omit from the column headed “Purposes”: P8750    

(d)insert in numerical order in the column headed “Purposes”: P14185

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

(a)omit from the column headed “Circumstances”: C8750         

(b)insert in numerical order in the column headed “Circumstances”: C14185

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

(a)omit from the column headed “Circumstances”: C10376        

(b)insert in numerical order in the column headed “Circumstances”: C14170

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

(a)omit from the column headed “Circumstances”: C10376        

(b)insert in numerical order in the column headed “Circumstances”: C14170

(c)omit from the column headed “Purposes”: P10376  

(d)insert in numerical order in the column headed “Purposes”: P14170

  1. Schedule 1, Part 1, entry for Upadacitinib in the form Tablet 15 mg [Maximum Quantity: 28; Number of Repeats: 4]

(a)omit from the column headed “Circumstances”: C10376        

(b)insert in numerical order in the column headed “Circumstances”: C14170

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

(a)omit from the column headed “Circumstances”: C10376        

(b)insert in numerical order in the column headed “Circumstances”: C14170

  1. Schedule 1, Part 1, entry for Zanubrutinib

omit from the column headed “Circumstances”: C13020

  1. Schedule 1, Part 2, omit entry for Budesonide with formoterol

  1. Schedule 1, Part 2, omit entry for Ertugliflozin with metformin

  1. Schedule 1, Part 2, omit entry for Nicotine

  1. Schedule 4, Part 1, entry for Abatacept

(a)omit:

C8746 P8746 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
Compliance with Written Authority Required procedures
C14182 P14182 Systemic juvenile idiopathic arthritis
Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)
Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Tofacitinib

(a)omit:

C8750 P8750 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C14185 P14185 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
Compliance with Written Authority Required procedures
  1. Schedule 4, Part 1, entry for Upadacitinib

(a)omit:

C10376 P10376 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, conducted within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C14170 P14170 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, conducted within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
Compliance with Written Authority Required procedures
  1. Schedule 4, Part 1, entry for Zanubrutinib

omit:

C13020 Waldenstrom macroglobulinaemia
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 July 2022; AND
The condition must have relapsed or been refractory to at least one prior chemo-immunotherapy, prior to having initiated non-PBS-subsidised treatment with this drug for this condition; OR
Patient must have been unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition prior to initiating non-PBS-subsidised treatment with this drug; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have been untreated with a Bruton's tyrosine kinase inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug; OR
Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when non-PBS-subsidised treatment was initiated for this condition.
Compliance with Authority Required procedures
  1. Schedule 5

insertas first entry:

Acalabrutinib GRP-27509 Capsule 100 mg Oral Calquence
Tablet 100 mg Oral CALQUENCE
  1. Schedule 5, entry for Adalimumab

omit:

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
Hadlima
Hyrimoz
Idacio
  1. Schedule 5, after entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [GRP-27088]

insert:

GRP-27089 Injection 40 mg in 0.4 mL pre-filled syringe Injection Yuflyma
Injection 40 mg in 0.8 mL pre-filled syringe Injection Amgevita
Hadlima
Hyrimoz
Idacio
  1. Schedule 5, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate) [GRP-17061]

(a)omit from the column headed “Brand”: Esomeprazole SZ

(b)omit from the column headed “Brand”: Esomeprazole Sandoz

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

(a)omit from the column headed “Brand”: Esomeprazole SZ

(b)omit from the column headed “Brand”: Esomeprazole Sandoz

  1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-15402]

omit from the column headed “Brand”: Ondansetron ODT GH

  1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-15983]

omit from the column headed “Brand”: Ondansetron ODT GH

  1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-16933]

omit from the column headed “Brand”: Ondansetron ODT GH

  1. Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-17042] 

omit from the column headed “Brand”: Ondansetron ODT GH

  1. Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) [GRP-17623]

omit from the column headed “Brand”: Rizatriptan-AU

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