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PB 71 of 2012 Other as amended, taking into account amendments up to National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 10)
This instrument revokes and replaces the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to determine the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands, and provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements).
Administered by: Health and Aged Care
Registered 27 Oct 2022
Start Date 01 Oct 2022
End Date 31 Oct 2022
Table of contents.

Commonwealth Coat of Arms of Australia

National Health (Listing of Pharmaceutical Benefits) Instrument 2012

PB 71 of 2012

made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the

National Health Act 1953

Compilation No. 123

Compilation date:                              1 October 2022

Includes amendments up to:            F2022L01291

Registered:                                         27 October 2022

This compilation is in 7 volumes

Volume 1:       sections 1–26 and Schedule 1 (Part 1: A–C)

Volume 2:       Schedule 1 (Part 1: D–K)

Volume 3:       Schedule 1 (Part 1: L–P)

Volume 4:       Schedule 1 (Part 1: Q–Z, Part 2), Schedules 2 and 3

Volume 5:       Schedule 4 (Part 1: A–E)

Volume 6:       Schedule 4 (Part 1: F–R)

Volume 7:       Schedule 4 (Part 1: S–Z, Part 3), Schedule 5 and
                        Endnotes

Each volume has its own contents

About this compilation

This compilation

This is a compilation of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 that shows the text of the law as amended and in force on 1 October 2022 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

1............ Name of Instrument....................................................................................................... 1

4............ Definitions..................................................................................................................... 1

5............ Drugs and medicinal preparations to which Part VII applies......................................... 2

6............ Form.............................................................................................................................. 3

7............ Manner of administration.............................................................................................. 3

8............ Brand and responsible person....................................................................................... 3

8A......... Schedule equivalent....................................................................................................... 3

9............ Authorised prescribers—Part 1 of Schedule 1.............................................................. 4

9A......... Authorised prescriber—Schedule 2............................................................................... 4

10.......... Prescription circumstances—Schedule 1....................................................................... 5

11.......... Authority required procedures....................................................................................... 5

12.......... Authority required procedures—submission of prescription......................................... 5

13.......... Authority required procedures—authorisation.............................................................. 6

14.......... Streamlined authority code............................................................................................ 8

15.......... Extended application of sections 11 to 14...................................................................... 8

16.......... Prescription circumstances—Schedule 2....................................................................... 8

17.......... Maximum quantity—Schedule 1................................................................................... 9

18.......... Maximum quantity conditions—Schedule 1.................................................................. 9

19.......... Maximum quantity—Schedule 2................................................................................. 10

20.......... Maximum number of repeats—Schedule 1................................................................. 10

21.......... Maximum number of repeats conditions—Schedule 1................................................ 11

22.......... Maximum number of repeats—Schedule 2................................................................. 11

23.......... Determined Quantity................................................................................................... 11

24.......... Pack Quantity.............................................................................................................. 12

25.......... Section 100 only supply.............................................................................................. 12

26.......... Prescriber bag only supply.......................................................................................... 13

Schedule 1—Ready‑prepared pharmaceutical benefits                                 15

Part 1—Ready‑prepared pharmaceutical benefits for prescription and supply     15


1  Name of Instrument

             (1)  This Instrument is the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

             (2)  This Instrument may also be cited as PB 71 of 2012.

4  Definitions

                   In this Instrument:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999;

Act means the National Health Act 1953;

authorised prescriber, for a pharmaceutical benefit, means a PBS prescriber (within the meaning of Part VII of the Act) authorised under section 9 or 9A to write a prescription for the supply of the benefit;

CFC means chlorofluorocarbon;

CFU means colony forming unit;

circumstances code means the letter ‘C’ followed by a number;

conditions code means the letters ‘CN’ followed by a number;

electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;

electronic prescription has the meaning given by the Regulations;

extemporaneously‑prepared pharmaceutical benefit means a pharmaceutical benefit other than a ready‑prepared pharmaceutical benefit;

General Statement for drugs for the treatment of hepatitis C means the statement set out in Part 3 of Schedule 4;

GP Management Plan means a comprehensive written plan for the treatment of a patient, prepared by a medical practitioner, that includes a description of the patient’s health care needs, management goals, actions to be taken by the patient and treatment and services the patient is likely to need;

I.M. means intramuscular;

I.U. means international unit;

I.V. means intravenous;

Medicare Benefits Schedule means the Health Insurance (General Medical Services Table) Regulations;

mmol means millimole;

palliative care patient means a patient with an active, progressive, far‑advanced disease for whom the prognosis is limited and the focus of care is the quality of life;

paper‑based prescription has the meaning given by the Regulations;

PBS means Pharmaceutical Benefits Scheme;

purposes code means the letter ‘P’ followed by a number;

ready‑prepared pharmaceutical benefit means a brand of a pharmaceutical item in relation to which a determination under subsection 85(6) of the Act is in force;

Regulations means the National Health (Pharmaceutical Benefits) Regulations 2017;

residential care service has the meaning given by the Regulations;

Streamlined Authority Code means the words ‘Streamlined Authority Code’ followed by a number;

Team Care Arrangements means a document prepared by a medical practitioner, following consultation with collaborating providers, that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide and the actions to be taken by the patient;

TGA means Therapeutic Goods Administration;

WHO means World Health Organisation.

Note:          Terms used in this Instrument have the same meaning as in the Act—see section 13 of the Legislative Instruments Act 2003. These terms include:

·      Chief Executive Medicare

·      pharmaceutical benefit

·      pharmaceutical item.

5  Drugs and medicinal preparations to which Part VII applies

             (1)  For paragraph 85(2)(a) of the Act, Part VII of the Act applies to:

                     (a)  a drug or medicinal preparation mentioned in the column headed ‘Listed Drug’ in:

                              (i)  Schedule 1; or

                             (ii)  Part 1 of Schedule 2; and

                     (b)  a medicinal preparation composed of 1 or more listed drugs mentioned in subparagraph (a)(ii).

             (2)  For subparagraph 85(2)(b)(i) of the Act, paragraph 85(2)(b) of the Act applies to a listed drug mentioned in subparagraph (1)(a)(ii).

             (3)  For subparagraph 85(2)(b)(ii) of the Act, paragraph 85(2)(b) of the Act applies to an additive mentioned in Part 2 of Schedule 2.

Note:          Part VII of the Act applies to medicinal preparations composed of 1 or more listed drugs mentioned in subsection (2) and 1 or more of the additives mentioned in subsection (3)—see paragraph 85(2)(b) of the Act.

6  Form

                   For subsection 85(3) of the Act, the column headed ‘Form’ in Schedule 1 lists the form or forms for a listed drug determined for that drug.

7  Manner of administration

             (1)  For subsection 85(5) of the Act, the manner of administration of a form of a listed drug mentioned in Schedule 1 is the manner of administration mentioned for that form of the drug in the column headed ‘Manner of Administration’ in Schedule 1.

             (2)  For paragraph 85A(2)(c) of the Act, if a manner of administration is mentioned in Schedule 1 for a form of a listed drug, a person writing a prescription for the supply of a pharmaceutical benefit that has the listed drug in that form must, if including a manner of administration in the prescription, direct that the pharmaceutical benefit be administered in that manner.

             (3)  For subsection (2), the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

8  Brand and responsible person

             (1)  A brand mentioned in the column headed ‘Brand’ in Schedule 1 for a pharmaceutical item is determined for subsection 85(6) of the Act for that pharmaceutical item.

             (2)  For subsection 84AF(1) of the Act, if a code is mentioned in the column in Schedule 1 headed ‘Responsible Person’ for a brand of a pharmaceutical item, the person mentioned in subsection (3) is the responsible person for the brand of the pharmaceutical item.

             (3)  For subsection (2), the person is the person mentioned in Schedule 3 for the code, with the ABN, if any, mentioned in Schedule 3 for the person.

             (4)  For subsections (1) and (2), the pharmaceutical item is the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

8A  Schedule equivalent

             (1)  For subsection 85(6A) of the Act:

                     (a)  a brand of a pharmaceutical item with an ‘a’ located in the column headed ‘Schedule Equivalent’ in Schedule 1, is to be treated as equivalent to another brand of that pharmaceutical item that also has an ‘a’ located in the column headed ‘Schedule Equivalent’ in Schedule 1;

                     (b)  where paragraph (a) applies to a brand of a pharmaceutical item, a brand of the same pharmaceutical item with a ‘b’ in the column headed ‘Schedule equivalent’ in Schedule 1, is to be treated as equivalent to another brand of that pharmaceutical item that also has a ‘b’ located in the column headed ‘Schedule Equivalent’ in Schedule 1; and

                     (c)  where a brand of a pharmaceutical item appears in Schedule 5, that brand is to be treated as equivalent to any brand of any pharmaceutical item that is in the same schedule equivalent group as that brand in Schedule 5.

9  Authorised prescribers—Part 1 of Schedule 1

          (1A)  For subsection 88(1) of the Act, a medical practitioner is authorised to write a prescription for the supply of any pharmaceutical benefit mentioned in Part 1 of Schedule 1.

             (1)  For subsection 88(1A) of the Act, a participating dental practitioner is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials PDP are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Part 1 of Schedule 1.

             (2)  For subsection 88(1C) of the Act, an authorised optometrist is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials AO are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Part 1 of Schedule 1.

             (3)  For subsection 88(1D) of the Act, an authorised midwife is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials MW are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Part 1 of Schedule 1.

             (4)  For subsection 88(1E) of the Act, an authorised nurse practitioner is authorised to write a prescription for the supply of a pharmaceutical benefit if the initials NP are mentioned for the pharmaceutical benefit in the column headed ‘Authorised Prescriber’ in Part 1 of Schedule 1.

             (5)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Part 1 of Schedule 1:

                     (a)  in the form mentioned in Part 1 of Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Part 1 of Schedule 1 for the form of the listed drug.

9A  Authorised prescriber—Schedule 2

                   For the purposes of subsection 88(1) of the Act, a medical practitioner is authorised to write a prescription for the supply of an extemporaneously‑prepared pharmaceutical benefit.

10  Prescription circumstances—Schedule 1

             (1)  This section applies to a pharmaceutical benefit if at least 1 circumstances code is mentioned in the column in Schedule 1 headed ‘Circumstances’ for the pharmaceutical benefit.

             (2)  For paragraph 85(7)(a) of the Act, the pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act.

             (3)  For paragraph 85(7)(b) of the Act, the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written are the circumstances mentioned in Part 1 of Schedule 4 for at least 1 of the circumstances codes mentioned in Schedule 1 for the pharmaceutical benefit.

             (4)  For subsection (1), the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

11  Authority required procedures

             (1)  This section applies to a pharmaceutical benefit if the circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit include any of the following:

                     (a)  Compliance with Authority Required procedures;

                     (b)  Compliance with Written Authority Required procedures;

                     (c)  Compliance with Telephone Authority Required procedures;

                     (d)  Compliance with Written or Telephone Authority Required procedures.

          (1A)  If the circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit include the words ‘Compliance with Telephone Authority Required procedures’ or ‘Compliance with Written or Telephone Authority Required procedures’ treat as if the words used are ‘Compliance with Authority Required procedures’.

Note:          If there is a Streamlined Authority Code section 14 continues to apply.

             (2)  A prescription for the supply of the pharmaceutical benefit must be:

                     (a)  submitted by the authorised prescriber to the Chief Executive Medicare in accordance with section 12; and

                     (b)  authorised by the Chief Executive Medicare in accordance with section 13.

12  Authority required procedures—submission of prescription

             (1)  A prescription is submitted in accordance with this subsection if:

                     (a)  the authorised prescriber submits to the Chief Executive Medicare:

                              (i)  the prescription itself; or

                             (ii)  for a medication chart prescription that is not an electronic prescription — the medication chart by which the prescription was written, or a copy of so much of that chart as would indicate that subsection 41(2) of the Regulations has been complied with; or

                     (b)  the authorised prescriber submits details of the prescription by telephone to the Chief Executive Medicare; or

                     (c)  the authorised prescriber submits the prescription in accordance with the instructions in an emergency telephone message provided to the authorised prescriber by the Chief Executive Medicare; or

                     (d)  the authorised prescriber submits details of the prescription in accordance with subsection 12(4A) to the Chief Executive Medicare, by means of electronic communication to obtain an electronic authority.

             (2)  If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Written Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1)(a) or (d).

             (3)  If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Telephone Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1)(b) or (c).

             (4)  If a circumstance mentioned in Part 1 of Schedule 4 for a circumstances code applying to the pharmaceutical benefit includes Compliance with Written or Telephone Authority Required procedures, the authorised prescriber must submit a prescription for the supply of the pharmaceutical benefit to the Chief Executive Medicare in accordance with paragraph (1)(a), (b) or (c).

          (4A)  The prescription submitted in accordance with paragraph 12(1)(d) must be:

                     (a)  given to the Chief Executive Medicare in writing; and

                     (b)  by means of an electronic communication; and

                     (c)  encrypted when it is given to the Chief Executive Medicare; and

                     (d)  in accordance with any other requirements that would need to be met in order for the requirements to give the information in writing to be taken to have been met under the Electronic Transactions Act 1999.

             (5)  For paragraph (1)(a), a prescription prepared and signed by the authorised prescriber in accordance with subsection (1) is taken to have been submitted by the authorised prescriber if it is submitted by his or her employee.

13  Authority required procedures—authorisation 

             (1)  A paper‑based prescription (other than a prescription submitted in accordance with paragraph 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the prescription, and:

                     (a)  if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — returning it to the authorised prescriber for alteration before the authorised prescriber gives it to the person in respect of whom it was prepared; or

                     (b)  by returning it to the authorised prescriber; or

                     (c)  if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.

          (1A)  A medication chart prescription (other than an electronic prescription, or a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the medication chart prescription, or a copy of the medication chart prescription, and:

                     (a)  if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— indicating this on the medication chart prescription or copy; and

                     (b)  returning the medication chart or copy to the authorised prescriber for alteration.

          (1B)  An electronic prescription (other than a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare writing his or her authorisation on the electronic prescription, and:

                     (a)  if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— by returning it, including by means of an electronic communication, to the authorised prescriber for alteration; or

                     (b)  by returning it, including by means of electronic communication to the authorised prescriber; or

                     (c)  if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.

             (2)  A prescription submitted in accordance with paragraph 12(1)(b) may be authorised by the Chief Executive Medicare telling the authorised prescriber by telephone, at the time the Chief Executive Medicare is given details of the prescription, that the prescription is authorised.

             (3)  A prescription submitted in accordance with paragraph 12(1)(d) may be authorised by the Chief Executive Medicare sending his or her authorisation, by electronic communication, including computer automated electronic communication, to the authorised prescriber.

          (3A)  If the prescription submitted is declined for authorisation, the authorised prescriber may seek review of the decision by the Chief Executive Medicare.

             (4)  If the Chief Executive Medicare authorises a prescription under subsection (2) or (3):

                     (a)  the Chief Executive Medicare must tell the authorised prescriber the number that has been allotted to the authorised prescription: and

                     (b)  the authorised prescriber must:

                              (i)  mark that number on the prescription; and

                             (ii)  retain a copy of the prescription showing the number marked in accordance with subparagraph (i) for 1 year from the date the prescription was authorised.

             (5)  For paragraph (4)(a), the Chief Executive Medicare must tell the authorised prescriber the number:

                              (i)  if the authorised prescriber is an authorised optometrist—by telephone; and

                             (ii)  in any other case—by telephone or by electronic communication.

             (6)  A prescription submitted in accordance with paragraph 12(1)(c) is taken to have been authorised by the Chief Executive Medicare if the authorised prescriber completes the prescription in accordance with the instructions given in the emergency telephone message.

14  Streamlined authority code

             (1)  This section applies to a pharmaceutical benefit if the circumstances mentioned in Schedule 4 for a circumstances code applying to the pharmaceutical benefit include a Streamlined Authority Code.

             (2)  The requirements of section 12 are taken to have been complied with, and the Chief Executive Medicare is taken to have authorised the prescription of the pharmaceutical benefit under section 13, if the authorised prescriber has written the Streamlined Authority Code on the prescription.

15  Extended application of sections 11 to 14

                 Sections 11 to 14 apply in relation to conditions and conditions codes as if the circumstances and circumstances codes mentioned in those sections were conditions and conditions codes.

Note:             Conditions are determined in sections 18 and 21.

16  Prescription circumstances—Schedule 2

             (1)  For paragraph 85(7)(a) of the Act, a pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A if:

                     (a)  it is:

                              (i)  a listed drug mentioned in Part 1 of Schedule 2; or

                             (ii)  an extemporaneously‑prepared pharmaceutical benefit that contains the listed drug; and

                     (b)  there are circumstances mentioned for the listed drug in the column headed ‘Circumstances’ in Part 1 of Schedule 2.

             (2)  For paragraph 85(7)(b) of the Act, the circumstances in which a prescription for the supply of a pharmaceutical benefit mentioned in subsection (1) may be written are:

                     (a)  for a listed drug mentioned in subparagraph (1)(a)(i)—the circumstances mentioned in the column headed ‘Circumstances’ in Part 1 of Schedule 2 for the drug; and

                     (b)  for an extemporaneously‑prepared pharmaceutical benefit mentioned in subparagraph (1)(a)(ii)—the circumstances mentioned in the column headed ‘Circumstances’ in Part 1 of Schedule 2 for each listed drug contained in the pharmaceutical benefit.

Note:          If an extemporaneously‑prepared pharmaceutical benefit contains more than one listed drug, a prescription for the supply of the pharmaceutical benefit may only be written if the circumstances mentioned for each of the listed drugs contained in the pharmaceutical benefit are met.

17  Maximum quantity—Schedule 1

             (1)  For paragraph 85A(2)(a) of the Act, the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit mentioned in Schedule 1 that may, in 1 prescription for the supply of the pharmaceutical benefit, be directed by an authorised prescriber to be supplied on any 1 occasion is the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for the pharmaceutical benefit and authorised prescriber.

             (2)  If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for a pharmaceutical benefit, the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ is the maximum for the particular purposes mentioned in Schedule 4 for each purposes code.

             (3)  If no purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’, the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.

             (4)  For subsection (1) the pharmaceutical item is the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

             (5)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

18  Maximum quantity conditions—Schedule 1

             (1)  This section applies to a pharmaceutical benefit if a conditions code is mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for a maximum quantity or number of units for the pharmaceutical benefit.

             (2)  For subsection 85A(2A) of the Act, the conditions which must be satisfied when writing a prescription for the supply of the pharmaceutical benefit to which a determination of a maximum quantity or number of units under paragraph 85A(2)(a) applies, are the conditions mentioned in Part 1 of Schedule 4 for the conditions code mentioned in Schedule 1 for the pharmaceutical benefit and the maximum quantity or number of units.

             (3)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

19  Maximum quantity—Schedule 2

             (1)  For paragraph 85A(2)(a) of the Act, the maximum quantity or number of units of an extemporaneously‑prepared pharmaceutical benefit of a type mentioned in Part 3 of Schedule 2 that may, in 1 prescription for the supply of the pharmaceutical benefit, be directed by an authorised prescriber to be supplied on any 1 occasion is the quantity or number of units mentioned in the column headed ‘Maximum Quantity’ in Part 3 of Schedule 2 for that type of pharmaceutical benefit.

             (2)  For subsection (1), the extemporaneously‑prepared pharmaceutical benefit is:

                     (a)  the listed drug mentioned in Part 1 of Schedule 2; or

                     (b)  an extemporaneously‑prepared pharmaceutical benefit that contains the listed drug.

20  Maximum number of repeats—Schedule 1

             (1)  For paragraph 85A(2)(b) of the Act, the maximum number of occasions an authorised prescriber may, in 1 prescription, direct that the supply of a pharmaceutical benefit mentioned in Schedule 1 be repeated is the number in the column in Schedule 1 headed ‘Number of Repeats’ for the pharmaceutical benefit and the authorised prescriber.

             (2)  If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for the pharmaceutical benefit, the number of repeats mentioned in the column in Schedule 1 headed ‘Number of Repeats’ is the maximum for the particular purposes mentioned in Schedule 4 for each purposes code.

             (3)  If no purposes code is mentioned in the column headed ‘Purposes’, the number of repeats mentioned in the column headed ‘Number of Repeats’ is the maximum for all purposes, other than a purpose for which a different maximum is mentioned for the same pharmaceutical benefit.

             (4)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

21  Maximum number of repeats conditions—Schedule 1

             (1)  This section applies to a pharmaceutical benefit if a conditions code is mentioned in the column in Schedule 1 headed ‘Number of Repeats’ for the maximum number of repeats for the pharmaceutical benefit.

             (2)  For subsection 85A(2A) of the Act, the conditions which must be satisfied when writing a prescription for the supply of the pharmaceutical benefit to which a determination of a maximum number of repeats under paragraph 85A(2)(b) applies, are the conditions mentioned in Part 1 of Schedule 4 for the conditions code mentioned in Schedule 1 for the pharmaceutical benefit and the maximum number of repeats.

             (3)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

22  Maximum number of repeats—Schedule 2

             (1)  For paragraph 85A(2)(b) of the Act, the maximum number of occasions an authorised prescriber may, in 1 prescription, direct that the supply of an extemporaneously‑prepared pharmaceutical benefit of a type mentioned in Part 3 of Schedule 2 be repeated is the number in the column headed ‘Number of Repeats’ in Part 3 of Schedule 2 for that type of pharmaceutical benefit.

             (2)  For this section, the extemporaneously‑prepared pharmaceutical benefit is:

                     (a)  the listed drug mentioned in Part 1 of Schedule 2; or

                     (b)  an extemporaneously‑prepared pharmaceutical benefit that contains the listed drug.

23  Determined Quantity

             (1)  For subsection 84AK(3) of the Act, the quantities or numbers of units of a pharmaceutical item that are determined quantities of a listed brand of the pharmaceutical item mentioned in Schedule 1 are the quantities or numbers of units mentioned in the column in Schedule 1 headed ‘Determined Quantity’ for the listed brand of the pharmaceutical item.

             (2)  For this section, the listed brand of the pharmaceutical item is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

             (3)  For this section, the pharmaceutical item is the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

24  Pack Quantity

             (1)  For subsection 84AK(2) of the Act, the quantities or numbers of units of a pharmaceutical item that are pack quantities of a listed brand of the pharmaceutical item mentioned in Schedule 1 are the quantities or numbers of units mentioned in the column in Schedule 1 headed ‘Pack Quantity’ for the listed brand of the pharmaceutical item.

             (2)  For this section, the listed brand of the pharmaceutical item is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

             (3)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

25  Section 100 only supply

             (1)  For subsection 85(2A) of the Act, if the code D(100) is mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a listed drug, the drug can only be supplied under special arrangements under section 100 of the Act.

             (2)  For paragraph 85(8)(a) of the Act, if the code PB(100) is mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit, the pharmaceutical benefit can only be supplied under special arrangements under section 100 of the Act.

             (3)  For paragraph 85(8)(b) of the Act, if the code C(100) is mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit, and a circumstances code is mentioned for the pharmaceutical benefit in the column headed ‘Circumstances’, the pharmaceutical benefit can be supplied in the circumstances identified in Part 1 of Schedule 4 for the circumstances code only under special arrangements under section 100 of the Act.

             (4)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.

26  Prescriber bag only supply

             (1)  For subsection 85(2AA) of the Act, if one or more of the codes D(MP), D(MW) and D(NP) are mentioned in the column headed ‘Section 100/ Prescriber Bag only’ in Schedule 1 for a listed drug other than the drug methoxyflurane, then, subject to subsection (3), the drug can only be supplied by:

                     (a)  where the code D(MP) is mentioned, medical practitioners under section 93 of the Act, and

                     (b)  where the code D(MW) is mentioned, authorised midwives under section 93AA of the Act, and

                     (c)  where the code D(NP) is mentioned, authorised nurse practitioners under section 93AB of the Act.

Note:          A declaration in force immediately before 1 October 2012 for the purposes of subsection 85(2A) of the Act declaring that the drug methoxyflurane can only be supplied under special arrangements under section 100 of the Act, continues in force and may be dealt with on and after 1 October 2012, as if the declaration had been made for the purposes of subsection 85(2AA) of the Act and declared that methoxyflurane can only be supplied under section 93 of the Act (see Item 18 of Schedule 3 to the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012).

             (2)  For subsection 85(7A) of the Act, if one or more of the codes PB(MP), PB(MW) and PB(NP) are mentioned in the column headed ‘Section 100/ Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit, then, subject to subsection (3), the pharmaceutical benefit can only be supplied by:

                     (a)  where the code PB(MP) is mentioned, medical practitioners under section 93 of the Act, and

                     (b)  where the code PB(MW) is mentioned, authorised midwives under section 93AA of the Act, and

                     (c)  where the code PB(NP) is mentioned, authorised nurse practitioners under section 93AB of the Act.

             (3)  If :

                     (a)  one or more of the codes D(MP), D(MW), and D(NP) are mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a listed drug; and

                     (b)  one or more of the codes PB(MP), PB(MW) and PB(NP) are also mentioned in the column headed ‘Section 100/Prescriber Bag only’ in Schedule 1 for a pharmaceutical benefit having the listed drug;

then:

                     (c)  the drug may be supplied as provided in subsection (1): and

                     (d)  the pharmaceutical benefit may be supplied as provided in subsection (2).

             (4)  For this section, the pharmaceutical benefit is the brand of the listed drug mentioned in Schedule 1:

                     (a)  in the form mentioned in Schedule 1 for the listed drug; and

                     (b)  with the manner of administration mentioned in Schedule 1 for the form of the listed drug.


Schedule 1Ready‑prepared pharmaceutical benefits

Note:       See sections 5 to 10, 16 to 18, 20, 21 and 23 to 26.

Part 1Ready‑prepared pharmaceutical benefits for prescription and supply

  

 

Listed Drug

Form

Manner of Administration

Schedule Equivalent

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Pack Quantity

Determined Quantity

Section 100/ Prescriber Bag only

Abacavir

Oral solution 20 mg (as sulfate) per mL, 240 mL

Oral

 

Ziagen

VI

MP NP

C4454 C4512

 

8

5

1

 

D(100)

Tablet 300 mg (as sulfate)

Oral

 

Ziagen

VI

MP NP

C4454 C4512

 

120

5

60

 

D(100)

Abacavir with lamivudine

Tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg

Oral

 

Abacavir/Lamivudine GH 600/300

GQ

MP NP

C4527 C4528

 

60

5

30

 

D(100)

Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg

Oral

 

ABACAVIR/LAMIVUDINE 600/300 SUN

RA

MP NP

C4527 C4528

 

60

5

30

 

D(100)

 

Abacavir/Lamivudine Mylan

AF

MP NP

C4527 C4528

 

60

5

30

 

D(100)

 

Kivexa

VI

MP NP

C4527 C4528

 

60

5

30

 

D(100)

Abacavir with lamivudine and zidovudine

Tablet containing abacavir 300 mg (as sulfate) with lamivudine 150 mg and zidovudine 300 mg

Oral

 

Trizivir

VI

MP NP

C4480 C4495

 

120

5

60

 

D(100)

Abatacept

Injection 125 mg in 1 mL single dose autoinjector

Injection

 

Orencia ClickJect

BQ

MP

C8627 C8638 C8655 C8746 C11776 C11805 C12378 C12385

P8638 P8746 P11776 P11805

4

3

4

 

 

MP

C8627 C8638 C8655 C8746 C11776 C11805 C12378 C12385

P8627 P8655 P12378 P12385

4

5

4

 

 

Injection 125 mg in 1 mL single dose pre‑filled syringe

Injection

 

Orencia

BQ

MP

C8627 C8638 C8655 C8746 C11776 C11805 C12378 C12385

P8638 P8746 P11776 P11805

4

3

4

 

 

MP

C8627 C8638 C8655 C8746 C11776 C11805 C12378 C12385

P8627 P8655 P12378 P12385

4

5

4

 

 

Injection 125 mg in 1 mL single dose autoinjector (s19A)

Injection

 

Orencia Clickject (Germany)

DZ

MP

C8627 C8638 C8655 C8746 C11776 C11805

P8638 P8746 P11776 P11805

4

3

4

 

 

 

 

 

 

 

MP

C8627 C8638 C8655 C8746 C11776 C11805

P8627 P8655

4

5

4

 

 

Powder for I.V. infusion 250 mg

Injection

 

Orencia

BQ

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

PB(100)

Abemaciclib

Tablet 50 mg

Oral

 

Verzenio

LY

MP

C13035 C13036 C13053

 

56

5

56

 

 

 

Tablet 100 mg

Oral

 

Verzenio

LY

MP

C13035 C13036 C13053

 

56

5

56

 

 

 

Tablet 150 mg

Oral

 

Verzenio

LY

MP

C13035 C13036 C13053

 

56

5

56

 

 

Abiraterone

Tablet containing abiraterone acetate 250 mg

Oral

 

Zytiga

JC

MP

C12700

 

120

2

120

 

 

Tablet containing abiraterone acetate 500 mg

Oral

 

Zytiga

JC

MP

C12700

 

60

2

60

 

 

Acalabrutinib

Capsule 100 mg

Oral

 

Calquence

AP

MP

C10652 C12481 C12495 C12500 C12501

 

56

5

56

 

 

Acamprosate

Tablet (enteric coated) containing acamprosate calcium 333 mg

Oral

a

Acamprosate Mylan

AL

MP NP

C5366

 

180

1

180

 

 

a

APO‑Acamprosate

TX

MP NP

C5366

 

180

1

180

 

 

a

Campral

AF

MP NP

C5366

 

180

1

180

 

 

Acarbose

Tablet 50 mg

Oral

a

Acarbose Mylan

AF

MP NP

 

 

90

5

90

 

 

 

 

a

GLYBOSAY

RW

MP NP

 

 

90

5

90

 

 

Tablet 100 mg

Oral

a

Acarbose Mylan

AF

MP NP

 

 

90

5

90

 

 

 

 

 

a

GLYBOSAY

RW

MP NP

 

 

90

5

90

 

 

Acetazolamide

Tablet 250 mg

Oral

 

Diamox

RW

MP NP

 

 

100

3

100

 

 

Aciclovir

Eye ointment 30 mg per g, 4.5 g

Application to the eye

a

ViruPOS

AE

MP NP

C5965

 

1

0

1

 

 

 

 

 

 

 

AO

C5964

 

1

0

1

 

 

 

 

a

XOROX

IX

MP NP

C5965

 

1

0

1

 

 

 

 

 

 

 

AO

C5964

 

1

0

1

 

 

Tablet 200 mg

Oral

a

Aciclovir APOTEX

TY

MP NP

C5936 C5942

P5936

50

0

50

 

 

a

Aciclovir Sandoz

HX

MP NP

C5936 C5942

P5936

50

0

25

 

 

a

APO‑Aciclovir

TX

MP NP

C5936 C5942

P5936

50

0

50

 

 

a

Aciclovir APOTEX

TY

MP NP

C5936 C5942

P5942

90

5

90

 

 

a

Aciclovir GH

GQ

MP NP

C5942

 

90

5

90

 

 

a

Aciclovir Sandoz

HX

MP NP

C5936 C5942

P5942

90

5

90

 

 

a

APO‑Aciclovir

TX

MP NP

C5936 C5942

P5942

90

5

90

 

 

a

GenRx Aciclovir

GX

MP NP

C5942

 

90

5

90

 

 

Tablet 800 mg

Oral

a

Aciclovir APOTEX

TY

MP NP

C5959 C5967

 

35

0

35

 

 

a

Aciclovir Sandoz

HX

MP NP

C5959 C5967

 

35

0

35

 

 

a

APO‑Aciclovir

TX

MP NP

C5959 C5967

 

35

0

35

 

 

Acitretin

Capsule 10 mg

Oral

a

Neotigason

TB

MP

C5727 C5789

 

100

2

100

 

 

a

ZETIN

RW

MP

C5727 C5789

 

100

2

100

 

 

Capsule 25 mg

Oral

a

Neotigason

TB

MP

C5727 C5789

 

100

2

100

 

 

a

ZETIN

RW

MP

C5727 C5789

 

100

2

100

 

 

Aclidinium

Powder for oral inhalation in breath actuated device 322 micrograms (as bromide) per dose, 60 doses

Inhalation by mouth

 

Bretaris Genuair

FK

MP NP

C4516

 

1

5

1

 

 

Aclidinium with formoterol

Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

 

Brimica Genuair

FK

MP NP

C7798

 

1

5

1

 

 

Adalimumab

Injection 20 mg in 0.2 mL pre‑filled syringe

Injection

 

Humira

VE

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

 

 

MP

C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11713

2

0

2

 

 

 

 

 

 

 

 

MP

C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P9715 P11715 P11716 P11761 P11852 P11854 P11855

2

3

2

 

 

 

 

 

 

 

 

MP

C9715 C11713 C11715 C11716 C11717 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11717 P11767 P11853 P11903 P11966

2

5

2

 

 

 

Injection 20 mg in 0.4 mL pre‑filled syringe

Injection

 

Amgevita

XT

MP

See Note 3

See Note 3

See Note 3

See Note 3

1

 

C(100)

 

 

 

 

 

 

MP

C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11713

2

0

1

 

 

 

 

 

 

 

 

MP

C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P9715 P11715 P11716 P11761 P11852 P11854 P11855

2

3

1

 

 

 

 

 

 

 

 

MP

C9715 C11579 C11713 C11715 C11716 C11717 C11718 C11761 C11767 C11852 C11853 C11854 C11855 C11903 C11966

P11579 P11717 P11718 P11767 P11853 P11903 P11966

2

5

1

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

1

 

C(100)

 

Injection 40 mg in 0.4 mL pre‑filled pen

Injection

 

Humira

VE

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P12273

4

2

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P12272 P12315

4

5

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

 

 

 

Injection 40 mg in 0.4 mL pre‑filled syringe

Injection

 

Humira

VE

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11704 P11711 P11717 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C8638 C9064 C9386 C9715 C11107 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

Injection 40 mg in 0.8 mL pre‑filled pen

Injection

 

Amgevita

XT

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Idacio

PK

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P12273

4

2

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P12273

4

2

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P12273

4

2

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P12273

4

2

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11529 P12272 P12315

4

5

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11529 P12272 P12315

4

5

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11529 P12272 P12315

4

5

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P11529 P12272 P12315

4

5

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11529 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12272 C12273 C12275 C12315 C12336 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P12275 P12336

6

0

2

 

 

 

Injection 40 mg in 0.8 mL pre‑filled syringe

Injection

 

Amgevita

XT

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Idacio

PK

MP

See Note 3

See Note 3

See Note 3

See Note 3

2

 

C(100)

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11713

2

0

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

2

2

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P8638 P9064 P9386 P11722 P11771 P11810 P11861 P11866 P11972 P12118 P12130 P12131 P12171 P12174 P12194 P12199

2

3

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11107 P12103 P12105 P12153 P12155 P12161 P12212

2

4

2

 

 

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P11523 P11524 P11579 P11604 P11605 P11606 P11631 P11634 P11635 P11704 P11711 P11717 P11718 P11720 P11767 P11769 P11772 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12175 P12176 P12189 P12190 P12214 P12228 P12234 P12240 P12354 P12364 P12366 P12391

2

5

2

 

 

 

 

 

 

 

 

MP

C11526 C12116

 

2

5

2

 

C(100)

 

 

 

 

Amgevita

XT

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Hadlima

RF

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Hyrimoz

SZ

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

 

 

 

Idacio

PK

MP

C8638 C9064 C9386 C9715 C11107 C11523 C11524 C11579 C11604 C11605 C11606 C11631 C11634 C11635 C11704 C11706 C11707 C11709 C11711 C11713 C11715 C11716 C11717 C11718 C11720 C11722 C11759 C11761 C11767 C11769 C11771 C11772 C11810 C11852 C11853 C11854 C11855 C11861 C11865 C11866 C11867 C11903 C11906 C11966 C11972 C12098 C12101 C12103 C12105 C12118 C12122 C12123 C12130 C12131 C12147 C12148 C12153 C12155 C12156 C12157 C12158 C12161 C12171 C12174 C12175 C12176 C12189 C12190 C12194 C12199 C12212 C12214 C12228 C12234 C12240 C12354 C12364 C12366 C12391

P9715 P11706 P11707 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147

6

0

2

 

 

 

Injection 80 mg in 0.8 mL pre‑filled pen

Injection

 

Humira

VE

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P12103 P12105 P12153 P12155 P12161 P12212

1

0

1

 

 

 

 

 

 

 

 

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P12273

2

2

1

 

 

 

 

 

 

 

 

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P12306

2

5

1

 

 

 

 

 

 

 

 

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278

3

0

1

 

 

 

Injection 80 mg in 0.8 mL pre‑filled syringe

Injection

 

Humira

VE

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P12103 P12105 P12153 P12155 P12161 P12212

1

0

1

 

 

 

 

 

 

 

 

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P12273

2

2

1

 

 

 

 

 

 

 

 

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P12306

2

5

1

 

 

 

 

 

 

 

 

MP

C11715 C11716 C11759 C11761 C11762 C11763 C11852 C11854 C11855 C12103 C12105 C12152 C12153 C12155 C12161 C12212 C12229 C12273 C12275 C12278 C12306

P11715 P11716 P11759 P11761 P11762 P11763 P11852 P11854 P11855 P12152 P12229 P12275 P12278

3

0

1

 

 

Adapalene with benzoyl peroxide

Gel 1 mg‑25 mg per g, 30 g

Application

 

Epiduo

GA

MP

C4898 C4961

P4961

1

1

1

 

 

MP

C4898 C4961

P4898

1

3

1

 

 

NP

C4898

 

1

3

1

 

 

Adefovir

Tablet containing adefovir dipivoxil 10 mg

Oral

 

APO‑Adefovir

TX

MP NP

C4490 C4510

 

60

5

30

 

D(100)

Adrenaline (epinephrine)

I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector

Injection

a

Adrenaline Jr Viatris

AF

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

a

Anapen Junior 150

XT

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

a

EpiPen Jr.

AL

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector

Injection

a

Adrenaline Viatris

AF

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

 

 

a

Anapen 300

XT

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

a

EpiPen

AL

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

I.M. injection 500 micrograms in 0.3 mL single dose syringe auto‑injector

Injection

 

Anapen 500

XT

MP NP

C4909 C4947 C8734

 

2

0

1

 

 

Injection 1 mg (as acid tartrate) in 1 mL (1 in 1,000)

Injection

 

Link Medical Products Pty Ltd

LM

PDP MP NP

 

 

5

0

5

 

 

MP NP

 

 

5

1

5

 

 

Afatinib

Tablet 20 mg

Oral

 

Giotrif

BY

MP

C4473 C7613

 

28

3

28

 

 

Tablet 30 mg

Oral

 

Giotrif

BY

MP

C4473 C7613

 

28

3

28

 

 

Tablet 40 mg

Oral

 

Giotrif

BY

MP

C4473 C7613

 

28

3

28

 

 

Tablet 50 mg

Oral

 

Giotrif

BY

MP

C4473 C7613

 

28

3