National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 5) (Cth)
PB 46 of 2021
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021
(No. 5)
National Health Act 1953
________________________________________________________________________
I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 27 May 2021
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
Name of Instrument
(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 5).
(2)This Instrument may also be cited as PB 46 of 2021.
Commencement
This Instrument commences on 1 June 2021.
Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
Schedule 1, Part 1, entry for 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”: C8651 C8652
(b)insert in numerical order in the column headed “Circumstances”: C11776 C11805
(c)omit from the column headed “Purposes”: P8651 P8652
(d)insert in numerical order in the column headed “Purposes”: P11776 P11805
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”: C8651 C8652
(b)insert in numerical order in the column headed “Circumstances”: C11776 C11805
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”: C8651 C8652
(b)insert in numerical order in the column headed “Circumstances”: C11776 C11805
(c)omit from the column headed “Purposes”: P8651 P8652
(d)insert in numerical order in the column headed “Purposes”: P11776 P11805
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”: C8651 C8652
(b)insert in numerical order in the column headed “Circumstances”: C11776 C11805
Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C9798 C11509 C11518 C11531
(b)omit from the column headed “Circumstances”: C11555
(c)omit from the column headed “Circumstances”: C11591
(d)insert in numerical order in the column headed “Circumstances”: C11713 C11715 C11716 C11717 C11761 C11767
(e)omit from the column headed “Purposes”: P9798 substitute: P11713
Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C9798 C11509 C11518 C11531
(b)omit from the column headed “Circumstances”: C11555
(c)omit from the column headed “Circumstances”: C11591
(d)insert in numerical order in the column headed “Circumstances”: C11713 C11715 C11716 C11717 C11761 C11767
(e)omit from the column headed “Purposes”: P11509 P11531 P11555
(f)insert in numerical order in the column headed “Purposes”: P11715 P11716 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9798 C11509 C11518 C11531
(b)omit from the column headed “Circumstances”: C11555
(c)omit from the column headed “Circumstances”: C11591
(d)insert in numerical order in the column headed “Circumstances”: C11713 C11715 C11716 C11717 C11761 C11767
(e)omit from the column headed “Purposes”: P11518
(f)omit from the column headed “Purposes”: P11591
(g)insert in numerical order in the column headed “Purposes”: P11717 P11767
Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C9798 C11509 C11516 C11518 C11531
(b)omit from the column headed “Circumstances”: C11555
(c)omit from the column headed “Circumstances”: C11591
(d)insert in numerical order in the column headed “Circumstances”: C11713 C11715 C11716 C11717 C11718 C11761 C11767
(e)omit from the column headed “Purposes”: P9798 substitute: P11713
Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C9798 C11509 C11516 C11518 C11531
(b)omit from the column headed “Circumstances”: C11555
(c)omit from the column headed “Circumstances”: C11591
(d)insert in numerical order in the column headed “Circumstances”: C11713 C11715 C11716 C11717 C11718 C11761 C11767
(e)omit from the column headed “Purposes”: P11509 P11531 P11555
(f)insert in numerical order in the column headed “Purposes”: P11715 P11716 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 20 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C9798 C11509 C11516 C11518 C11531
(b)omit from the column headed “Circumstances”: C11555
(c)omit from the column headed “Circumstances”: C11591
(d)insert in numerical order in the column headed “Circumstances”: C11713 C11715 C11716 C11717 C11718 C11761 C11767
(e)omit from the column headed “Purposes”: P11516 P11518
(f)omit from the column headed “Purposes”: P11591
(g)insert in numerical order in the column headed “Purposes”: P11717 P11718 P11767
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9798 substitute: P11713
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9679
(o)omit from the column headed “Purposes”: P11509 P11513
(p)omit from the column headed “Purposes”: P11531 P11544
(q)omit from the column headed “Purposes”: P11555
(r)omit from the column headed “Purposes”: P11574
(s)insert in numerical order in the column headed “Purposes”: P11706 P11707 P11709 P11715 P11716 P11759 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P8631
(o)omit from the column headed “Purposes”: P8678 P8702
(p)insert in numerical order in the column headed “Purposes”: P11722 P11771 P11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P8627
(o)omit from the column headed “Purposes”: P11518
(p)omit from the column headed “Purposes”: P11569
(q)omit from the column headed “Purposes”: P11591 P11593
(r)omit from the column headed “Purposes”: P11602 P11603
(s)insert in numerical order in the column headed “Purposes”: P11704 P11711 P11717 P11720 P11767 P11769 P11772
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2;
Pack Quantity: 2]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 2;
Pack Quantity: 4]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5;
Pack Quantity: 2]
(a)omit from the column headed “Responsible Person”: VE
(b)omit from the column headed “Circumstances”: C8627 C8631
(c)omit from the column headed “Circumstances”: C8678 C8702
(d)omit from the column headed “Circumstances”: C9679
(e)omit from the column headed “Circumstances”: C9798
(f)omit from the column headed “Circumstances”: C11509 C11513
(g)omit from the column headed “Circumstances”: C11518 C11531
(h)omit from the column headed “Circumstances”: C11544
(i)omit from the column headed “Circumstances”: C11555
(j)omit from the column headed “Circumstances”: C11569
(k)omit from the column headed “Circumstances”: C11574
(l)omit from the column headed “Circumstances”: C11591 C11593
(m)omit from the column headed “Circumstances”: C11602 C11603
(n)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5;
Pack Quantity: 4]
(a)omit from the column headed “Responsible Person”: VE
(b)omit from the column headed “Circumstances”: C8627 C8631
(c)omit from the column headed “Circumstances”: C8678 C8702
(d)omit from the column headed “Circumstances”: C9679
(e)omit from the column headed “Circumstances”: C9798
(f)omit from the column headed “Circumstances”: C11509 C11513
(g)omit from the column headed “Circumstances”: C11518 C11531
(h)omit from the column headed “Circumstances”: C11544
(i)omit from the column headed “Circumstances”: C11555
(j)omit from the column headed “Circumstances”: C11569
(k)omit from the column headed “Circumstances”: C11574
(l)omit from the column headed “Circumstances”: C11591 C11593
(m)omit from the column headed “Circumstances”: C11602 C11603
(n)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 6; Number of Repeats: 0;
Pack Quantity: 2]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9679
(o)omit from the column headed “Purposes”: P11509 P11513
(p)omit from the column headed “Purposes”: P11531 P11544
(q)omit from the column headed “Purposes”: P11555
(r)omit from the column headed “Purposes”: P11574
(s)insert in numerical order in the column headed “Purposes”: P11706 P11707 P11709 P11715 P11716 P11759 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Maximum Quantity: 6; Number of Repeats: 0;
Pack Quantity: 6]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9679
(o)omit from the column headed “Purposes”: P11509 P11513
(p)omit from the column headed “Purposes”: P11531 P11544
(q)omit from the column headed “Purposes”: P11555
(r)omit from the column headed “Purposes”: P11574
(s)insert in numerical order in the column headed “Purposes”: P11706 P11707 P11709 P11715 P11716 P11759 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9798 substitute: P11713
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9679
(o)omit from the column headed “Purposes”: P11509 P11513
(p)omit from the column headed “Purposes”: P11531 P11544
(q)omit from the column headed “Purposes”: P11555
(r)omit from the column headed “Purposes”: P11574
(s)insert in numerical order in the column headed “Purposes”: P11706 P11707 P11709 P11715 P11716 P11759 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P8631
(o)omit from the column headed “Purposes”: P8678 P8702
(p)insert in numerical order in the column headed “Purposes”: P11722 P11771 P11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P8627
(o)omit from the column headed “Purposes”: P11518
(p)omit from the column headed “Purposes”: P11569
(q)omit from the column headed “Purposes”: P11591 P11593
(r)omit from the column headed “Purposes”: P11602 P11603
(s)insert in numerical order in the column headed “Purposes”: P11704 P11711 P11717 P11720 P11767 P11769 P11772
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 6; Number of Repeats: 0; Pack Quantity: 2]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9679
(o)omit from the column headed “Purposes”: P11509 P11513
(p)omit from the column headed “Purposes”: P11531 P11544
(q)omit from the column headed “Purposes”: P11555
(r)omit from the column headed “Purposes”: P11574
(s)insert in numerical order in the column headed “Purposes”: P11706 P11707 P11709 P11715 P11716 P11759 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Maximum Quantity: 6; Number of Repeats: 0; Pack Quantity: 6]
(a)omit from the column headed “Circumstances”: C8627 C8631
(b)omit from the column headed “Circumstances”: C8678 C8702
(c)omit from the column headed “Circumstances”: C9679
(d)omit from the column headed “Circumstances”: C9798
(e)omit from the column headed “Circumstances”: C11509 C11513
(f)omit from the column headed “Circumstances”: C11518 C11531
(g)omit from the column headed “Circumstances”: C11544
(h)omit from the column headed “Circumstances”: C11555
(i)omit from the column headed “Circumstances”: C11569
(j)omit from the column headed “Circumstances”: C11574
(k)omit from the column headed “Circumstances”: C11591 C11593
(l)omit from the column headed “Circumstances”: C11602 C11603
(m)insert in numerical order in the column headed “Circumstances”: C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810
(n)omit from the column headed “Purposes”: P9679
(o)omit from the column headed “Purposes”: P11509 P11513
(p)omit from the column headed “Purposes”: P11531 P11544
(q)omit from the column headed “Purposes”: P11555
(r)omit from the column headed “Purposes”: P11574
(s)insert in numerical order in the column headed “Purposes”: P11706 P11707 P11709 P11715 P11716 P11759 P11761
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen
substitute:
| Injection 40 mg in 0.8 mL pre-filled pen | Injection | Amgevita | AN | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) |
| Hadlima | OQ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Hyrimoz | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Idacio | PK | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6946 | 4 | 2 | 2 | |||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6946 | 4 | 2 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6946 | 4 | 2 | 2 | |||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6946 | 4 | 2 | 2 | |||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11529 P11534 P11624 | 4 | 5 | 2 | |||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11529 P11534 P11624 | 4 | 5 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11529 P11534 P11624 | 4 | 5 | 2 | |||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11529 P11534 P11624 | 4 | 5 | 2 | |||
| Amgevita | AN | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6963 P9714 P9715 P10892 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 | |||
| Hadlima | OQ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6963 P9714 P9715 P10892 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6963 P9714 P9715 P10892 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 | |||
| Idacio | PK | MP | C6696 C6946 C6963 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C10892 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11529 C11534 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11624 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6963 P9714 P9715 P10892 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 |
Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe
substitute:
| Injection 40 mg in 0.8 mL pre-filled syringe | Injection | Amgevita | AN | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) |
| Hadlima | OQ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Hyrimoz | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Idacio | PK | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Amgevita | AN | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Hadlima | OQ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Idacio | PK | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11713 | 2 | 0 | 2 | |||
| Amgevita | AN | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Hadlima | OQ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Idacio | PK | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 2 | 2 | 2 | |||
| Amgevita | AN | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Hadlima | OQ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Idacio | PK | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P8638 P9064 P9069 P9078 P9155 P9386 P9409 P9414 P9428 P9429 P9498 P9503 P9564 P11722 P11771 P11810 | 2 | 3 | 2 | |||
| Amgevita | AN | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Hadlima | OQ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Idacio | PK | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P11089 P11096 P11107 P11113 P11122 P11138 P11154 | 2 | 4 | 2 | |||
| Amgevita | AN | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Hadlima | OQ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Hyrimoz | SZ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Idacio | PK | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P6696 P8608 P9063 P9380 P9431 P9717 P11523 P11524 P11538 P11541 P11542 P11545 P11547 P11548 P11551 P11552 P11560 P11572 P11579 P11587 P11594 P11604 P11605 P11606 P11609 P11618 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 | 2 | 5 | 2 | |||
| MP | C11526 | 2 | 5 | 2 | C(100) | |||||
| Amgevita | AN | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 | |||
| Hadlima | OQ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 | |||
| Hyrimoz | SZ | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 | |||
| Idacio | PK | MP | C6696 C8608 C8638 C9063 C9064 C9069 C9078 C9155 C9380 C9386 C9409 C9414 C9428 C9429 C9431 C9498 C9503 C9564 C9714 C9715 C9717 C11089 C11096 C11107 C11113 C11122 C11138 C11154 C11514 C11523 C11524 C11538 C11541 C11542 C11545 C11547 C11548 C11550 C11551 C11552 C11560 C11571 C11572 C11576 C11577 C11579 C11587 C11594 C11604 C11605 C11606 C11609 C11618 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 | P9714 P9715 P11514 P11550 P11571 P11576 P11577 P11706 P11707 P11709 P11715 P11716 P11759 P11761 | 6 | 0 | 2 |
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C11558
(b)omit from the column headed “Circumstances”: C11595
(c)omit from the column headed “Circumstances”: C11615 C11622
(d)omit from the column headed “Circumstances”: C11636
(e)omit from the column headed “Circumstances”: C11640
(f)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C11558
(b)omit from the column headed “Circumstances”: C11595
(c)omit from the column headed “Circumstances”: C11615 C11622
(d)omit from the column headed “Circumstances”: C11636
(e)omit from the column headed “Circumstances”: C11640
(f)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C11558
(b)omit from the column headed “Circumstances”: C11595
(c)omit from the column headed “Circumstances”: C11615 C11622
(d)omit from the column headed “Circumstances”: C11636
(e)omit from the column headed “Circumstances”: C11640
(f)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled pen [Maximum Quantity: 3; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C11558
(b)omit from the column headed “Circumstances”: C11595
(c)omit from the column headed “Circumstances”: C11615 C11622
(d)omit from the column headed “Circumstances”: C11636
(e)omit from the column headed “Circumstances”: C11640
(f)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
(g)omit from the column headed “Purposes”: P11558
(h)omit from the column headed “Purposes”: P11595
(i)omit from the column headed “Purposes”: P11615 P11622
(j)omit from the column headed “Purposes”: P11636
(k)omit from the column headed “Purposes”: P11640
(l)insert in numerical order in the column headed “Purposes”: P11758 P11759 P11761 P11762 P11763 P11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C6963
(b)insert in numerical order in the column headed “Circumstances”: C10892
(c)omit from the column headed “Circumstances”: C11558
(d)omit from the column headed “Circumstances”: C11595
(e)omit from the column headed “Circumstances”: C11615 C11622
(f)omit from the column headed “Circumstances”: C11636
(g)omit from the column headed “Circumstances”: C11640
(h)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C6963
(b)insert in numerical order in the column headed “Circumstances”: C10892
(c)omit from the column headed “Circumstances”: C11558
(d)omit from the column headed “Circumstances”: C11595
(e)omit from the column headed “Circumstances”: C11615 C11622
(f)omit from the column headed “Circumstances”: C11636
(g)omit from the column headed “Circumstances”: C11640
(h)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C6963
(b)insert in numerical order in the column headed “Circumstances”: C10892
(c)omit from the column headed “Circumstances”: C11558
(d)omit from the column headed “Circumstances”: C11595
(e)omit from the column headed “Circumstances”: C11615 C11622
(f)omit from the column headed “Circumstances”: C11636
(g)omit from the column headed “Circumstances”: C11640
(h)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
Schedule 1, Part 1, entry for Adalimumab in the form Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 3; Number of Repeats: 0]
(a)insert in numerical order in the column headed “Circumstances”: C6963
(b)insert in numerical order in the column headed “Circumstances”: C10892
(c)omit from the column headed “Circumstances”: C11558
(d)omit from the column headed “Circumstances”: C11595
(e)omit from the column headed “Circumstances”: C11615 C11622
(f)omit from the column headed “Circumstances”: C11636
(g)omit from the column headed “Circumstances”: C11640
(h)insert in numerical order in the column headed “Circumstances”: C11758 C11759 C11761 C11762 C11763 C11789
(i)insert in numerical order in the column headed “Purposes”: P6963 P10892
(j)omit from the column headed “Purposes”: P11558
(k)omit from the column headed “Purposes”: P11595
(l)omit from the column headed “Purposes”: P11615 P11622
(m)omit from the column headed “Purposes”: P11636
(n)omit from the column headed “Purposes”: P11640
(o)insert in numerical order in the column headed “Purposes”: P11758 P11759 P11761 P11762 P11763 P11789
Schedule 1, Part 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Amdarone | XT | MP NP | C5665 | 30 | 5 | 30 |
Schedule 1, Part 1, entry for Amitriptyline in each of the forms: Tablet containing amitriptyline hydrochloride 10 mg; Tablet containing amitriptyline hydrochloride 25 mg; and Tablet containing amitriptyline hydrochloride 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Amitriptyline | TY | MP NP | 50 | 2 | 50 |
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”: C8631
(b)omit from the column headed “Circumstances”: C8726
(c)insert in numerical order in the column headed “Circumstances”: C11689 C11807
(d)omit from the column headed “Purposes”: P8631
(e)omit from the column headed “Purposes”: P8726
(f)insert in numerical order in the column headed “Purposes”: P11689 P11807
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”: C8631
(b)omit from the column headed “Circumstances”: C8726
(c)insert in numerical order in the column headed “Circumstances”: C11689 C11807
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”: C8631
(b)omit from the column headed “Circumstances”: C8726
(c)insert in numerical order in the column headed “Circumstances”: C11689 C11807
(d)omit from the column headed “Purposes”: P8631
(e)omit from the column headed “Purposes”: P8726
(f)insert in numerical order in the column headed “Purposes”: P11689 P11807
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”: C8631
(b)omit from the column headed “Circumstances”: C8726
(c)insert in numerical order in the column headed “Circumstances”: C11689 C11807
Schedule 1, Part 1, after entry for Beclometasone with formoterol
insert:
| Beclometasone with formoterol and glycopyrronium | Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses | Inhalation by mouth | Trimbow | EU | MP NP | C10167 | 1 | 5 | 1 |
Schedule 1, Part 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL
(a)omit from the column headed “Brand”: Avastin substitute: Mvasi
(b)omit from the column headed “Responsible Person”: RO substitute: AN
(c)omit from the column headed “Circumstances”: C4584 C4587 C4594 C4814 C4939 C4968 C6337 C6353 C9102 C9149 C9166 C9346 C9347 C9454 C9566 C10959
Schedule 1, Part 1, entry for Bisacodyl
substitute:
| Bisacodyl | Suppositories 10 mg, 10 | Rectal | a | Dulcolax | VZ | MP NP | C5640 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 5 | 1 |
| a | Petrus Bisacodyl Suppositories | PP | MP NP | C5640 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 5 | 1 | |||
| a | Dulcolax | VZ | MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | ||
| a | Petrus Bisacodyl Suppositories | PP | MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | ||
| Suppositories 10 mg, 12 | Petrus Bisacodyl Suppositories | PP | MP NP | C5640 C5775 C5819 C5823 C5851 C5866 C5879 | P5640 P5775 P5819 P5823 P5851 P5866 P5879 | 3 | 4 | 1 | |||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||||
| Enemas 10 mg in 5 mL, 25 | Rectal | Bisalax | AS | MP NP | C5613 C5640 C5685 C5720 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 1 | 2 | 1 | ||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 1 | C(100) | |||||
| Tablet 5 mg | Oral | Lax-Tab | AE | MP NP | C5613 C5640 C5685 C5720 C5775 C5776 C5804 | P5613 P5640 P5685 P5720 P5775 P5776 P5804 | 200 | 2 | 200 | ||
| MP | See Note 2 | See Note 2 | See Note 2 | See Note 2 | 200 | C(100) |
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bortezomib Juno | JU | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bortezomib Juno | JU | MP | C11099 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, Part 1, entry for Botulinum toxin type A purified neurotoxin complex
(a)omit from the column headed “Circumstances”: C5262
(b)insert in numerical order in the column headed “Circumstances”: C11784
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 | C9212 | See Note 3 | See Note 3 | 1 | PB(100) |
| Injection (modified release) 16 mg in 0.32 mL pre-filled syringe | Injection | Buvidal Weekly | UR | MP NP | C9212 | See Note 3 | See Note 3 | 1 | PB(100) | |
| Injection (modified release) 24 mg in 0.48 mL pre-filled syringe | Injection | Buvidal Weekly | UR | MP NP | C9212 | See Note 3 | See Note 3 | 1 | PB(100) | |
| Injection (modified release) 32 mg in 0.64 mL pre-filled syringe | Injection | Buvidal Weekly | UR | MP NP | C9212 | See Note 3 | See Note 3 | 1 | PB(100) | |
| Injection (modified release) 64 mg in 0.18 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C9212 | See Note 3 | See Note 3 | 1 | PB(100) | |
| Injection (modified release) 96 mg in 0.27 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C9212 | See Note 3 | See Note 3 | 1 | PB(100) | |
| Injection (modified release) 100 mg in 0.5 mL pre-filled syringe | Injection | Sublocade | IR | MP NP | C9212 | See Note 3 | See Note 3 | 1 | PB(100) | |
| Injection (modified release) 128 mg in 0.36 mL pre-filled syringe | Injection | Buvidal Monthly | UR | MP NP | C9212 | See Note 3 | See Note 3 | 1 | PB(100) | |
| Injection (modified release) 300 mg in 1.5 mL pre-filled syringe | Injection | Sublocade | IR | MP NP | C9212 | See Note 3 | See Note 3 | 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 | C6451 | See Note 3 | See Note 3 | 7 | PB(100) | |
| Tablet (sublingual) 2 mg (as hydrochloride) | Sublingual | Subutex | IR | MP NP | C6451 | See Note 3 | See Note 3 | 7 | PB(100) | |
| Tablet (sublingual) 8 mg (as hydrochloride) | Sublingual | Subutex | IR | MP NP | C6451 | See Note 3 | See Note 3 | 7 | PB(100) |
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed "Circumstances": C11686 C11748
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed "Circumstances": C11686 C11748
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed "Circumstances": C11686 C11748
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed "Circumstances": C11686 C11748
(d)omit from the column headed “Purposes”: P8705 P8753
(e)insert in numerical order in the column headed "Purposes": P11686 P11748
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed "Circumstances": C11686 C11748
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed "Circumstances": C11686 C11748
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed "Circumstances": C11686 C11748
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”: C8705
(b)omit from the column headed “Circumstances”: C8753
(c)insert in numerical order in the column headed “Circumstances”: C11686 C11748
(d)omit from the column headed “Purposes”: P8705 P8753
(e)insert in numerical order in the column headed “Purposes”: P11686 P11748
Schedule 1, Part 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Ciprofloxacin | TY | MP NP | C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780 | 14 | 0 | 14 |
Schedule 1, Part 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Ciprofloxacin | TY | MP NP | C5614 C5615 C5687 C5688 C5689 C5722 C5780 | 14 | 0 | 14 |
Schedule 1, Part 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APX-Citalopram | TY | MP NP | C4755 | 28 | 5 | 28 |
Schedule 1, Part 1, entry for Clonazepam in the form Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent)
(a)insert in numerical order in the column headed “Circumstances”: C11683
(b)insert in numerical order in the column headed “Purposes”: P6295
Schedule 1, Part 1, after entry for Clonazepam in the form Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent) [Maximum Quantity: 5; Number of Repeats: 0]
insert:
Schedule 4, Part 1, entry for Tofacitinib
(a)omit:
| C8631 | P8631 | Severe active rheumatoid arthritis Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine of more 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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised 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 The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. 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. 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. | Compliance with Written Authority Required procedures |
(b)omit:
| C8726 | P8726 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. 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. 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. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C11689 | P11689 | Severe active rheumatoid arthritis Initial treatment - Initial 3 (re-commencement of treatment after a break in biological medicine of more 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 previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised 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 The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. 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. 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. | Compliance with Written Authority Required procedures |
| C11807 | P11807 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form(s); and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. 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. 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. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Upadacitinib
(a)omit:
| C10393 | P10393 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. 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. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C11813 | P11813 | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. 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. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
Schedule 5, after entry for Desmopressin in the form Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation,
50 actuations, 5 mL [GRP-24629]
insert:
| Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL, USP (Apotex) | Nasal | Desmopressin Nasal Spray USP (Apotex) |
Schedule 5, entry for Sertraline in the form Tablet 50 mg (as hydrochloride) [GRP-24879]
insert in alphabetical order in the column headed “Brand”: Sertraline generichealth
Schedule 5, entry for Sertraline in the form Tablet 100 mg (as hydrochloride) [GRP-24880]
insert in alphabetical order in the column headed “Brand”: Sertraline generichealth
Schedule 5, after entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine
200 mg [GRP-21638]
insert:
| Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg | Oral | Tenofovir/Emtricitabine Sandoz 301/200 |
Schedule 6, entry for Somatropin
omit:
| Somatropin | Injection 4 mg (12 i.u.) vial with diluent (with preservative) | Injection |
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