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PB 46 of 2021 Other as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 28 May 2021
Tabling HistoryDate
Tabled HR01-Jun-2021
Tabled Senate15-Jun-2021
To be repealed 25 Aug 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

 

 

 

 

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

 

1          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.

2          Commencement

This Instrument commences on 1 June 2021.

3          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

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

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

[2]             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 

[3]             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

[4]             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 

[5]             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

[6]             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 

[7]             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

[8]             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

[9]             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

[10]           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

[11]           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

[12]           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

[13]           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

[14]           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

[15]           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

[16]           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

[17]           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

[18]           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

[19]           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

[20]           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

[21]           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

[22]           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

[23]           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

[24]           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

[25]           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

[26]           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

[27]           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

[28]           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

[29]           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

 

 

[30]           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

 

 

[31]           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

[32]           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

[33]           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

[34]           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

[35]           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

[36]           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


 

[37]           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

[38]           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

[39]           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

 

 

[40]           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

 

 

[41]           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

[42]           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

[43]           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

[44]           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

[45]           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

 

 

[46]           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

[47]           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)

[48]           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)

[49]           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)

[50]           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 

[51]           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)

[52]           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         

[53]           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         

[54]           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       


 

[55]           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 

[56]           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       

[57]           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       

[58]           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       

[59]           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


 

[60]           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

 

 

[61]           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

 

 

[62]           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

 

 

[63]           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  

[64]           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:

 

 

 

 

 

 

MP NP

C6295 C11683

P11683

5

1

5

 

 

[65]           Schedule 1, Part 1, entry for Clonazepam in the form Oral liquid 2.5 mg per mL, 10 mL [Maximum Quantity: 2; Number of Repeats: 0]

                   (a)        omit from the column headed “Circumstances”: C6140

                   (b)        insert in numerical order in the column headed “Circumstances”: C11746

[66]           Schedule 1, Part 1, entry for Clonazepam in the form Oral liquid 2.5 mg per mL, 10 mL [Maximum Quantity: 2; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C6140

                   (b)        insert in numerical order in the column headed “Circumstances”: C11746

                   (c)        omit from the column headed “Purposes”: P6140            substitute: P11746

[67]           Schedule 1, Part 1, entry for Clonazepam in the form Tablet 500 micrograms [Maximum Quantity: 100; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances” (all instances): C6140

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C11746 

                   (c)        omit from the column headed “Purposes” (all instances): P6140    substitute: P11746

[68]           Schedule 1, Part 1, entry for Clonazepam in the form Tablet 500 micrograms [Maximum Quantity: 200; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances” (all instances): C6140

                   (b)        insert in numerical order in the column headed “Circumstances” (all instances): C11746

[69]           Schedule 1, Part 1, entry for Clonazepam in the form Tablet 2 mg [Maximum Quantity: 100; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances” C6140

                   (b)        insert in numerical order in the column headed “Circumstances”: C11746 

                   (c)        omit from the column headed “Purposes”: P6140            substitute: P11746

[70]           Schedule 1, Part 1, entry for Clonazepam in the form Tablet 2 mg [Maximum Quantity: 200; Number of Repeats: 2]

                   (a)        omit from the column headed “Circumstances” C6140

                   (b)        insert in numerical order in the column headed “Circumstances”: C11746

[71]           Schedule 1, Part 1, omit entry for Dalteparin

[72]           Schedule 1, Part 1, after entry for Desmopressin in the form Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL

                           insert:

 

Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL, USP (Apotex)

Nasal

 

Desmopressin Nasal Spray USP (Apotex)

DZ

MP

C5266 C5267 C5342

P5267 P5342

1

5

1

 

 

 

 

 

 

 

NP

C5267 C5342

 

1

5

1

 

 

 

 

 

 

 

MP

C5266 C5267 C5342

P5266

2

5

1

 

 

[73]           Schedule 1, Part 1, entry for Diclofenac in the form Suppository containing diclofenac sodium 100 mg

                           omit:

 

 

 

 

 

 

MP NP

 

P6149

40

3

20

 

 

 


 

[74]           Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100; Number of Repeats: 0]

                           omit from the column headed “Circumstances” (all instances): C6256 C6282

[75]           Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100; Number of Repeats: 3] 

                           omit from the column headed “Circumstances” (all instances): C6149 C6214 C6283

[76]           Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50; Number of Repeats: 0]

                           omit from the column headed “Circumstances” (all instances): C6256 C6282

[77]           Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50; Number of Repeats: 3]

                           omit from the column headed “Circumstances” (all instances): C6149 C6214 C6283

[78]           Schedule 1, Part 1, entry for Epirubicin

                           omit:

 

Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL

Injection/intravesical

 

Epirubicin ACT

JU

MP

 

 

See Note 3

See Note 3

1

 

D(100)

[79]           Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances”: C8631 

                   (b)        omit from the column headed “Circumstances”: C8661 

                   (c)        insert in numerical order in the column headed “Circumstances”: C11688 C11689

                   (d)        omit from the column headed “Purposes”: P8631           

                   (e)        omit from the column headed “Purposes”: P8661           

                    (f)        insert in numerical order in the column headed “Purposes”: P11688 P11689

[80]           Schedule 1, Part 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances”: C8631 

                   (b)        omit from the column headed “Circumstances”: C8661 

                   (c)        insert in numerical order in the column headed “Circumstances”: C11688 C11689


 

[81]           Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances” (all instances): C8631 

                   (b)        omit from the column headed “Circumstances” (all instances): C8661  

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C11688 C11689

                   (d)        omit from the column headed “Purposes” (all instances): P8631

                   (e)        omit from the column headed “Purposes” (all instances): P8661

                    (f)        insert in numerical order in the column headed “Purposes” (all instances): P11688 P11689

[82]           Schedule 1, Part 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances” (all instances): C8631 

                   (b)        omit from the column headed “Circumstances” (all instances): C8661  

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C11688 C11689

[83]           Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1; Number of Repeats: 3]

                   (a)        omit from the column headed “Circumstances” (all instances): C8631 

                   (b)        omit from the column headed “Circumstances” (all instances): C8661  

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C11688 C11689

                   (d)        omit from the column headed “Purposes” (all instances): P8631

                   (e)        omit from the column headed “Purposes” (all instances): P8661

                    (f)        insert in numerical order in the column headed “Purposes” (all instances): P11688 P11689

[84]           Schedule 1, Part 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1; Number of Repeats: 5]

                   (a)        omit from the column headed “Circumstances” (all instances): C8631 

                   (b)        omit from the column headed “Circumstances” (all instances): C8661  

                   (c)        insert in numerical order in the column headed “Circumstances” (all instances): C11688 C11689

[85]           Schedule 1, Part 1, entry for Fentanyl

                           substitute:

Fentanyl

Lozenge 200 micrograms
(as citrate)

Buccal

 

Actiq

TB

MP NP

C5904 C5915

P5915

9

0

9

 

 

 

 

 

 

 

 

MP NP

C5904 C5915

P5904

60

0

30

 

 

 

Lozenge 400 micrograms
(as citrate)

Buccal

 

Actiq

TB

MP NP

C5904 C5915

P5915

9

0

9

 

 

 

 

 

 

 

MP NP

C5904 C5915

P5904

60

0

30

 

 

 

Lozenge 600 micrograms
(as citrate)

Buccal

 

Actiq

TB

MP NP

C5904 C5915

P5915

9

0

9

 

 

 

 

 

 

 

MP NP

C5904 C5915

P5904

60

0

30

 

 

 

Lozenge 800 micrograms
(as citrate)

Buccal

 

Actiq

TB

MP NP

C5904 C5915

P5915

9

0

9

 

 

 

 

 

 

 

MP NP

C5904 C5915

P5904

60

0

30

 

 

 

Lozenge 1200 micrograms
(as citrate)

Buccal

 

Actiq

TB

MP NP

C5904 C5915

P5915

9

0

9

 

 

 

 

 

 

 

MP NP

C5904 C5915

P5904

60

0

30

 

 

 

Lozenge 1600 micrograms
(as citrate)

Buccal

 

Actiq

TB

MP NP

C5904 C5915

P5915

9

0

9

 

 

 

 

 

 

 

MP NP

C5904 C5915

P5904

60

0

30

 

 

 

Transdermal patch 1.28 mg

Transdermal

 

Denpax

AF

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

 

 

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 2.063 mg

Transdermal

 

Dutran 12

EA

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fenpatch 12

ZP

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Dutran 12

EA

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fenpatch 12

ZP

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 2.1 mg

Transdermal

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Durogesic 12

JC

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Durogesic 12

JC

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 2.55 mg

Transdermal

 

Denpax

AF

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

 

 

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 4.125 mg

Transdermal

 

Dutran 25

EA

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fenpatch 25

ZP

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Dutran 25

EA

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fenpatch 25

ZP

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 4.2 mg

Transdermal

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Durogesic 25

JC

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Durogesic 25

JC

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 5.10 mg

Transdermal

 

Denpax

AF

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

 

 

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 8.25 mg

Transdermal

 

Dutran 50

EA

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fenpatch 50

ZP

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Dutran 50

EA

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fenpatch 50

ZP

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 8.4 mg

Transdermal

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Durogesic 50

JC

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Durogesic 50

JC

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 7.65 mg

Transdermal

 

Denpax

AF

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

 

 

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 12.375 mg

Transdermal

 

Dutran 75

EA

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fenpatch 75

ZP

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Dutran 75

EA

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fenpatch 75

ZP

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 12.6 mg

Transdermal

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Durogesic 75

JC

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Durogesic 75

JC

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 10.20 mg

Transdermal

 

Denpax

AF

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

 

 

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 16.5 mg

Transdermal

 

Dutran 100

EA

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fenpatch 100

ZP

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Dutran 100

EA

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fenpatch 100

ZP

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Transdermal patch 16.8 mg

Transdermal

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Durogesic 100

JC

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P10745 P10747 P10751

5

0

5

 

 

 

 

 

APO-Fentanyl

TX

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Durogesic 100

JC

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

 

 

Fentanyl Sandoz

SZ

MP NP

C10745 C10747 C10751 C11696

P11696

10

0

5

 

 

 

Tablet (orally disintegrating)
100 micrograms (as citrate)

Buccal

 

Fentora

TB

MP NP

C6026 C6027

P6026

8

0

4

 

 

 

 

 

 

 

MP NP

C6026 C6027

P6027

56

0

28

 

 

 

Tablet (sublingual)
100 micrograms (as citrate)

Sublingual

 

Abstral

FK

MP NP

C5904 C5915

P5915

20

0

10

 

 

 

 

 

 

 

MP NP

C5904 C5915

P5904

60

0

30