Federal Register of Legislation - Australian Government

Primary content

PB 116 of 2010 Arrangements as amended, taking into account amendments up to National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 1) (PB 6 of 2018)
Administered by: Health
Registered 01 Feb 2018
Start Date 01 Feb 2018

Commonwealth Coat of Arms of Australia

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

made under subsection 100(1) of the

National Health Act 1953

Compilation No. 79

Compilation date:                              1 February 2018

Includes amendments up to:            PB 6 of 2018

Registered:                                         1 February 2018

 

About this compilation

This compilation

This is a compilation of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) that shows the text of the law as amended and in force on 1 February 2018 (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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

Part 1Preliminary                                                                                                                                        1

Division 1—General                                                                                                                                1

1............ Name of Special Arrangement....................................................................................... 1

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

Division 2—HSD pharmaceutical benefits                                                                                   7

5............ Pharmaceutical benefits covered by this Special Arrangement...................................... 7

6............ Application of Part VII of the Act................................................................................. 7

7............ Responsible person....................................................................................................... 7

8............ Authorised Prescriber.................................................................................................... 8

9............ Prescription circumstances............................................................................................ 8

9A......... HSD pharmaceutical benefits which may be supplied to public hospital admitted patients       8

Division 3—HSD Authority Required procedures                                                                10

10.......... HSD Authority Required procedures.......................................................................... 10

Division 4—Maximum quantity and maximum number of repeats                              11

14.......... Maximum quantity...................................................................................................... 11

15.......... Maximum number of repeats....................................................................................... 12

Division 5—Section 100 only                                                                                                            13

16.......... Section 100 only supply.............................................................................................. 13

Part 2—Supply of HSD pharmaceutical benefits                                                                       14

Division 1—General requirements for supply                                                                         14

17.......... Entitlement to HSD pharmaceutical benefits................................................................ 14

17A....... Modified application of paragraph 92A(1)(f) conditions of approval.......................... 14

18.......... Supply of HSD pharmaceutical benefits under this Special Arrangement................... 14

Division 2—Repeat prescriptions                                                                                                   16

19.......... Application of regulation 25........................................................................................ 16

20.......... No repeats for visitors................................................................................................. 16

Division 3Prescribing HSD pharmaceutical benefits that have non‑CAR drugs 17

21.......... Methods of prescribing HSD pharmaceutical benefits that have non‑CAR drugs....... 17

22A....... Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have non‑CAR drugs........................................................................................................................... 17

Division 4Prescribing HSD pharmaceutical benefits that have CAR drugs       18

23.......... Prescriptions for HSD pharmaceutical benefits that have CAR drugs......................... 18

23A....... Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have CAR drugs.................................................................................................................................... 18

24.......... HSD pharmaceutical benefits that have CAR drugs—quantity exceptions.................. 18

25.......... HSD pharmaceutical benefits that have CAR drugs—repeat exceptions..................... 23

26.......... Application of regulation 13 in relation to CAR drugs................................................ 28

Part 4Claiming procedures and payment amounts                                                              29

Division 2Modified section 99AAA claims by approved public hospitals            29

Subdivision 1—General requirements                                                                                          29

30.......... How claims to be made—modified section 99AAA claiming..................................... 29

31.......... Limit on number of prescriptions in one claim............................................................ 29

Subdivision 3—Payment of claims                                                                                                29

35.......... Payments to suppliers that are approved hospital authorities for public hospitals........ 29

Division 3—Payments to suppliers of HSD pharmaceutical benefits that are approved hospital authorities for private hospitals or approved pharmacists or approved medical practitioners                                                                                                                                                30

36.......... Payments to certain suppliers of HSD pharmaceutical benefits................................... 30

Part 5—Dispensed price                                                                                                                             31

Division 1—Dispensed price for supply of an HSD pharmaceutical benefit by a hospital authority for a public hospital                                                                                                                 31

37.......... The dispensed price—supply by public hospital......................................................... 31

38.......... Where quantity is less than a pack quantity................................................................. 31

Division 2—Dispensed price for supply of HSD pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or approved medical practitioner                                                                                                                      32

39.......... The dispensed price—supply by an approved hospital authority for a private hospital or by an approved pharmacist or approved medical practitioner...................................................................................... 32

40.......... Mark‑up...................................................................................................................... 33

41.......... Where quantity is less than a pack quantity................................................................. 34

42.......... Dispensing fee............................................................................................................. 34

Division 3—Dispensed price—other matters                                                                           35

44.......... Rounding up of dispensed price.................................................................................. 35

Part 6Patient contributions                                                                                                                 36

46.......... Patient contributions in relation to approved hospital authorities................................. 36

47.......... Patient contributions for claims by approved pharmacists or approved medical practitioners   36

48.......... Additional patient contributions................................................................................... 36

Part 7Miscellaneous                                                                                                                                 37

49.......... Compliance and audit arrangements............................................................................ 37

50.......... PBS Safety Net........................................................................................................... 37

51.......... Application of Act and Part VII instruments to approved suppliers and prescriptions etc        37

Part 8Approval of certain hospital authorities                                                                        39

52.......... Approval of certain public hospital authorities............................................................ 39

Part 9Transitional arrangements                                                                                                    40

53.......... Approvals of certain hospital authorities of public hospitals....................................... 40

54.......... Transitional arrangements for existing public hospital medication chart prescribing and paperless claiming            40

55.......... Transitional arrangements for existing non‑medication chart public hospital paperless claiming              40

56.......... Transitional arrangements for repeat prescriptions...................................................... 41

Schedule 1—Pharmaceutical benefits covered by this Special Arrangement and related information                                                                                                                  42

Schedule 2—Responsible Person Codes                                                                        106

Schedule 3—Circumstances and Purposes Codes                                              108

Schedule 3 Part 1General statement for drugs for the treatment of hepatitis C       415

Schedule 4—Patient contributions                                                                                     421

Endnotes                                                                                                                                                             422

Endnote 1—About the endnotes                                                                                                    422

Endnote 2—Abbreviation key                                                                                                        423

Endnote 3—Legislation history                                                                                                     424

Endnote 4—Amendment history                                                                                                   428


Part 1Preliminary

Division 1General

1  Name of Special Arrangement

             (1)  This Special Arrangement is the National Health (Highly specialised drugs program) Special Arrangement 2010.

             (2)  This Special Arrangement may also be cited as PB 116 of 2010.

4  Definitions

                   In this Special Arrangement:

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

accredited prescriber of medication for the treatment of hepatitis B means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of hepatitis B for this Special Arrangement.

accredited prescriber of medication for the treatment of Hepatitis C means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of Hepatitis C for this Special Arrangement.

accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS for this Special Arrangement.

accredited prescriber of medication for the treatment of schizophrenia means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of schizophrenia for this Special Arrangement.

Act means the National Health Act 1953.

affiliated specialist medical practitioner means a medical practitioner who:

                     (a)  is affiliated with the hospital at or from which the patient is receiving treatment; and

                     (b)  is either:

                              (i)  a staff hospital specialist; or

                             (ii)  a visiting or consulting specialist of the hospital.

approved hospital authority, for a hospital, means the hospital authority for the hospital that:

                     (a)  is approved:

                              (i)  by the Minister under section 94 of the Act; or

                             (ii)  by the Chief Executive Medicare under section 52 of this Special Arrangement; or

                     (b)  was approved under section 52 of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 and the approval:

                              (i)  is not suspended; or

                             (ii)  has not been revoked.

Note:          The Instrument mentioned in paragraph (b) is also known as PB 63 of 2010.

approved private hospital means a private hospital that has an approved hospital authority.

approved public hospital means a public hospital that has an approved hospital authority.

authorised prescriber, for an HSD pharmaceutical benefit, means a person who is a kind of person identified by a prescriber code mentioned in the column in Schedule 1 headed ‘Authorised Prescriber’ for the benefit.

benefit card means any of the following:

                     (a)  a PBS Entitlement Card;

                     (b)  a PBS Safety Net Concession Card;

                     (c)  a Pensioner Concession Card;

                     (d)  a Health Care Card (including Low Income Health Care Card and Foster Child Health Care Card);

                     (e)  a Commonwealth Seniors Health Card;

                      (f)  a Cleft Lip and Palate Card;

                     (g)  a DVA Gold Card;

                     (h)  a DVA White Card;

                      (i)  a DVA Orange Card;

                      (j)  War Widow/Widower Transport Card;

                     (k)  a card or voucher approved by the Chief Executive Medicare for this paragraph.

CAR drug (Complex Authority Required drug) means any of the following highly specialised drugs:

                       a)  abatacept

                      b)  adalimumab

                       c)  ambristenan

                      d)  azacitidine

                       e)  bosentan

                       f)  eculizumab

                       g)  eltrombopag

                      h)  epoprostenol

                       i)  etanercept

                       j)  iloprost

                      k)  infliximab

                       l)  ivacaftor

                     m)  lenalidomide

                      n)  macitentan

                      o)  mepolizumab

                      p)  omalizumab

                      q)  pasireotide

                     qa)  pegvisomant

                       r)  pomalidomide

                       s)  riociguat

                       t)  rituximab

                      u)  romiplostim

                      v)  sildenafil

                      w)  tadalafil

                      x)  tocilizumab

                     xa)  ustekinumab

                      y)  vedolizumab

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

Department means the Department administered by the Minister who administers the National Health Act 1953.

dispensed price:

                     (a)  for the supply of an HSD pharmaceutical benefit by a hospital authority for a public hospital—has the meaning given by section 37; and

                     (b)  for the supply of an HSD pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist—has the meaning given by section 39.

eligible medical practitioner, for the prescription of an HSD pharmaceutical benefit under this Special Arrangement to an eligible patient, means a person:

                     (a)  who is an affiliated specialist medical practitioner; or

                     (b)  who is, for the prescription of medication for the treatment of HIV or AIDS—an accredited prescriber of medication for the treatment of HIV or AIDS; or

                   (ba)  who is, for the prescription of medication for the treatment of hepatitis B—an accredited prescriber of medication for the treatment of hepatitis B; or

                   (bb)  who is, for the prescription of medication for the treatment of schizophrenia—an accredited prescriber of medication for the treatment of schizophrenia; or

                     (c)  who is, for the prescription of medication for the treatment of hepatitis C:

                              (i)  an accredited prescriber of medication for the treatment of hepatitis C; or

                             (ii)  a medical practitioner, for Daclatasvir, Ledipasvir with sofosbuvir, Ribavirin, Sofosbuvir, Paritaprevir with ritonavir with ombitasvir and dasabuvir, Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin, and Grazoprevir with elbasvir; or

                     (d)  who is, for the prescription of medication for maintenance therapy if it is impractical to obtain a prescription from the treating affiliated specialist medical practitioner and the treating staff hospital specialist has agreed to the prescription—a medical practitioner; or

                     (e)  who is, for the prescription of medication for maintenance therapy—a medical practitioner whom the Commonwealth and the State or Territory Government has agreed may give such a prescription.

eligible patient means a person who

                     (a)  is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and

                     (b)  if receiving treatment at or from a public hospital, is receiving medical treatment by a medical practitioner as:

                              (i)  a non‑admitted patient; or

                             (ii)  a day admitted patient; or

                            (iii)  a patient on discharge; or

                            (iv)  an admitted patient who has been prescribed a HSD pharmaceutical benefit referred to in section 9A.

entitlement number, for a patient, means the number listed on the patient’s benefit card.

General Statement for drugs for the treatment of hepatitis C means the statement set out in Schedule 3 Part 1.

highly specialised drug means a listed drug mentioned in Schedule 1.

Note:          Special Arrangements under section 100 of the Act apply to pharmaceutical benefits with drugs that have been declared by the Minister under subsection 85(2) of the Act. The drugs in Schedule 1 have all been so declared.

hospital authority means:

(a) for a public hospital—the governing body of the hospital; or

(b) for a private hospital—the proprietor of the hospital.

HSD pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.

item code, for a drug that has a particular form, manner of administration and brand, means the code for the form, manner of administration and brand for the drug set out in the Department’s website.

Note:          The website address is http://www.pbs.gov.au.

medication chart prescription has the meaning given in the Regulations, but does not include a medication chart prescription for a person receiving treatment in a residential care service.

medication for the treatment of hepatitis B means any of the following:

                     (a)  adefovir

                     (b)  entecavir

                     (c)  interferon alfa‑2a

                     (d)  interferon alfa‑2b

                     (e)  lamivudine

                      (f)  peginterferon alfa‑2a

                     (g)  tenofovir

medication for the treatment of HIV or AIDS means any of the following:

                     (a)  abacavir

                     (b)  abacavir with lamivudine

                     (c)  abacavir with lamivudine and zidovudine

                     (d)  atazanavir

                   (da)  atazanavir with cobicistat

                     (e)  azithromycin

                      (f)  darunavir

                     (g)  darunavir with cobicistat

                     (h)  didanosine

                      (i)  dolutegravir

                      (j)  dolutegravir with abacavir and lamivudine

                     (k)  doxorubicin - pegylated liposomal

                      (l)  efavirenz

                    (m)  emtricitabine

                     (n)  emtricitabine with rilpivirine with tenofovir alafenamide

                     (o)  emtricitabine with tenofovir alafenamide

                     (p)  enfuvirtide

                     (q)  etravirine

                      (r)  fosamprenavir

                      (t)  ganciclovir

                     (u)  indinavir

                     (v)  lamivudine

                    (w)  lamivudine with zidovudine

                     (x)  lopinavir with ritonavir

                     (y)  maraviroc

                     (z)  nevirapine

                    (za)  raltegravir

                   (zb)  rifabutin

                    (zc)  rilpivirine

                   (zd)  ritonavir

                    (ze)  saquinavir

                    (zf)  stavudine

                    (zg)  tenofovir

                   (zh)  tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

                    (zi)  tenofovir with emtricitabine

                    (zj)  tenofovir with emtricitabine and efavirenz

                   (zk)  tenofovir with emtricitabine, elvitegravir and cobicistat

                    (zl) tenofovir with emtricitabine and rilpivirine

                  (zm)  valganciclovir

                   (zn)  tipranavir

                   (zo)  zidovudine

medication for the treatment of schizophrenia means clozapine.

non‑CAR drug means a highly specialised drug that is not a complex authority required (CAR) drug.

other Special Arrangement means another Special Arrangement under section 100 of the Act.

prescriber code has the meaning given by paragraph 8(2)(b).

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

residential care service has the meaning given by the Regulations.

Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.

streamlined authority code means the number mentioned in subsection 13(1).

under co‑payment data means information relating to a supply of a HSD pharmaceutical benefit by an approved pharmacist, approved medical practitioner or approved hospital authority for a hospital where a claim is not payable as the dispensed price for the supply of the HSD pharmaceutical benefit does not exceed the amount that the supplier was entitled to charge under subsection 46(2) or subsection 47(2) of this Special Arrangement.

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

·    approved ex‑manufacturer price

·       approved medical practitioner

·    approved pharmacist

·    claimed price

·    hospital

·    medical practitioner

·    Chief Executive Medicare

·    pack quantity

·    pharmaceutical benefit

·    pharmaceutical item

·    private hospital

·    proportional ex‑manufacturer price

·    public hospital.

Division 2HSD pharmaceutical benefits

5  Pharmaceutical benefits covered by this Special Arrangement

             (1)  This Special Arrangement applies to each HSD pharmaceutical benefit mentioned in Schedule 1.

             (2)  Each HSD pharmaceutical benefit to which this Special Arrangement applies is a brand of a 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.

Note:          Each listed drug mentioned in Schedule 1 is a highly specialised drug—see definition of highly specialised drug in section 4. Each listed drug has been declared by the Minister under subsection 85(2) of the Act. The form, manner of administration and brand mentioned in Schedule 1 have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

6  Application of Part VII of the Act

             (1)  Each HSD pharmaceutical benefit supplied in accordance with this Special Arrangement is supplied under Part VII of the Act.

             (2)  A provision of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act, applies subject to this Special Arrangement.

Note:          See subsection 100(3) of the Act.

7  Responsible person

             (1)  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 paragraph (2)(a) is the responsible person for the brand of the pharmaceutical item.

             (2)  For subsection (1):

                     (a)  the person is the person mentioned in Schedule 2 for the code, with the ABN, if any, mentioned in Schedule 2 for the person; and

                     (b)  the pharmaceutical item is the listed drug mentioned in Schedule 1:

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

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

Note 1:       An HSD pharmaceutical benefit mentioned in Schedule 1 is a brand of a pharmaceutical item.

Note 2:       A person identified by a code in the column headed ‘Responsible Person’ in Schedule 1 has been determined by the Minister, under section 84AF of the Act, to be the responsible person for the brand of the pharmaceutical item.

8  Authorised Prescriber

             (1)  Only an authorised prescriber may write a prescription for the supply of an HSD pharmaceutical benefit to an eligible patient.

             (2)  For this Special Arrangement:

                     (a)  only an eligible medical practitioner is an authorised prescriber; and

                     (b)  the prescriber code for the authorised prescriber is the letters ‘EMP’.

             (3)  A reference in this Special Arrangement to an eligible medical practitioner is a reference to an authorised prescriber.

             (4)  For subsection (1), the HSD 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.

             (5)  Subsection 88(1) of the Act does not apply to the supply of an HSD pharmaceutical benefit under this Special Arrangement.

9  Prescription circumstances

             (1)  If at least 1 circumstances code is mentioned in the column in Schedule 1 headed ‘Circumstances’ for an HSD pharmaceutical benefit, the circumstances mentioned in Schedule 3 for the code are the circumstances in which a prescription for the supply of the HSD pharmaceutical benefit may be written.

             (2)  For subsection (1), the HSD 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.

9A  HSD pharmaceutical benefits which may be supplied to public hospital admitted patients

The HSD pharmaceutical benefits which may be supplied to public hospital admitted patients under this Special Arrangement are referred to in the table below:

                     (a)  if a drug is referred to in the table below and paragraphs (b), (c) and (d) do not apply – all HSD pharmaceutical benefits containing that drug;

                     (b) if a form of the drug is referred to in the  table below and paragraphs (c) and (d) do not apply – all HSD pharmaceutical benefits containing that drug in that form;

                     (c) if a manner of administration of that form of the drug is referred to in the table below and paragraph (d) does not apply – all HSD pharmaceutical benefits containing that drug in that form with that manner of administration;

                     (d)  if a brand of a drug in that form with that manner of administration is referred to in the table below – that brand of HSD pharmaceutical benefit containing that drug in that form with that manner of administration;

                     (e) if one or more circumstances and/or purposes code is identified in the table below – the HSD pharmaceutical benefit must be prescribed for one of those circumstances and/or purposes.

 

Drug

Form

Manner of Administration

Brand

Circumstances

Code

Purposes

Code

eculizumab

 

 

 

 

 

 

Note:          A circumstances and/or purposes code mentioned in the above table is the same circumstances and/or purposes code referred to in section 9 (circumstances code) or section 14 or section 15 (purposes code).

Division 3HSD Authority Required procedures

10  HSD Authority Required procedures

             (1)  This section applies to an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 for a circumstances code mentioned in Schedule 1 for the HSD pharmaceutical benefit includes:

(a)   Compliance with Authority Required procedures;

(b)   Compliance with Written Authority Required procedures;

(c)   Compliance with Written or Telephone Authority Required procedures;

(d)   Compliance with modified Authority Required procedures.

          (1A)  If the circumstances mentioned in Schedule 3 for a circumstances code mentioned in Schedule 1 for a HSD pharmaceutical benefit include ‘Compliance with Written or Telephone Authority Required procedures’ then treat as if the words used are ‘Compliance with  Authority Required procedures’. 

             (2)  The Authority Required procedures as provided for in sections 11 to 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 are to be followed.

             (3)  In addition to the requirements of subsection (2), where ‘Compliance with modified Authority Required procedures’ appears in the circumstances mentioned in Schedule 3 for the code, in addition to ‘Compliance with Written or Telephone Authority Required procedures’, any other requirement included in the circumstances is to be followed as part of the Authority Required procedures. 

Division 4Maximum quantity and maximum number of repeats

14  Maximum quantity

             (1)  The maximum quantity or number of units of the pharmaceutical item in an HSD pharmaceutical benefit that may, in 1 prescription for the supply of the HSD pharmaceutical benefit, be directed to be supplied by an eligible medical practitioner is the quantity or number of units mentioned in the column in Schedule 1 headed ‘Maximum Quantity’ for the HSD pharmaceutical benefit.

             (2)  If at least 1 purposes code is mentioned in the column in Schedule 1 headed ‘Purposes’ for an HSD 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 3 for each 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 HSD 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 HSD 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.

             (6)  Subsection (1) applies, in relation to an HSD pharmaceutical benefit that has a CAR drug, subject to section 24.

Note 1:       The maximum quantities and numbers of units mentioned in the column headed ‘Maximum quantity’ in Schedule 1 have been determined by the Minister under paragraph 85A(2)(a) of the Act.

Note 2:       See also section 26.

             (7)  A determination made under paragraph 85A(2)(a) of the Act does not apply to an HSD pharmaceutical benefit supplied in accordance with this Special Arrangement in relation to the maximum quantity of the HSD pharmaceutical benefit that can be supplied under this Special Arrangement if the maximum quantity mentioned in the determination differs from the maximum quantity mentioned in this section.

15  Maximum number of repeats

             (1)  The maximum number of occasions an eligible medical practitioner may, in 1 prescription, direct that the supply of the pharmaceutical benefit be repeated is the number in the column in Schedule 1 headed ‘Number of Repeats’ for the pharmaceutical benefit.

             (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 number for the particular purposes mentioned in Schedule 3 for each 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 number 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.

             (5)  Subsection (1) applies, in relation to an HSD pharmaceutical benefit that has a CAR drug, subject to section 25.

Note:          See also section 26.

             (6)  A determination made under paragraph 85A(2)(b) of the Act does not apply to an HSD pharmaceutical benefit supplied in accordance with this Special Arrangement in relation to the maximum number of occasions an eligible medical practitioner may, in 1 prescription, direct, under this Special Arrangement, that the supply of the HSD pharmaceutical benefit be repeated if the maximum number mentioned in the determination differs from the maximum number mentioned in this section.

Division 5Section 100 only

16  Section 100 only supply

             (1)  If the letter ‘D’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for a listed drug, the listed drug may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the listed drug.

             (2)  An HSD pharmaceutical benefit that has a drug mentioned in subsection (1) is not available for general supply on the Pharmaceutical Benefits Scheme.

Note:          The Minister has declared, under subsection 85(2A) of the Act, that the listed drug can only be supplied under a section 100 Special Arrangement.

             (3)  If the letters ‘PB’ are mentioned in the column in Schedule 1 headed ‘Section 100 only’ for an HSD pharmaceutical benefit, the HSD pharmaceutical benefit may be supplied only in accordance with this Special Arrangement and any other Special Arrangement relating to the pharmaceutical benefit.

             (4)  An HSD pharmaceutical benefit mentioned in subsection (3) is not available for general supply on the Pharmaceutical Benefits Scheme.

Note:          The Minister has determined, under paragraph 85(8)(a) of the Act, that this HSD pharmaceutical benefit can only be supplied under a section 100 Special Arrangement.

             (5)  If the letter ‘C’ is mentioned in the column in Schedule 1 headed ‘Section 100 only’ for an HSD pharmaceutical benefit, the HSD pharmaceutical benefit may be supplied in the circumstances mentioned in Schedule 3 for the circumstances code in the column headed ‘Circumstances’ only in accordance with this Special Arrangement and any other Special Arrangement relating to the HSD pharmaceutical benefit.

             (6)  An HSD pharmaceutical benefit mentioned in subsection (5) is not available in the circumstances mentioned in subsection (5) for general supply on the Pharmaceutical Benefits Scheme.

Note:          The Minister has determined, under paragraph 85(8)(b) of the Act, that 1 or more of the circumstances in which a prescription for the supply of the HSD pharmaceutical benefit may be written are circumstances in which the benefit can only be supplied under a section 100 Special Arrangement.

Part 2Supply of HSD pharmaceutical benefits

Division 1General requirements for supply

17  Entitlement to HSD pharmaceutical benefits

                   Subject to this Special Arrangement, an eligible patient is entitled to be supplied an HSD pharmaceutical benefit under this Special Arrangement without payment or other consideration, other than a charge made in accordance with Part 6.

17A  Modified application of paragraph 92A(1)(f) conditions of approval

             (1)  Section 8 of the conditions of approval for approved pharmacists under paragraph 92A(1)(f) of the Act does not apply to the supply of a HSD pharmaceutical benefit, once prepared as a final product ready for infusion to a person, when the HSD pharmaceutical benefit has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.

             (2)  For the purposes of this section, shelf life means the period of time that a medicine can be stored and still be considered safe and effective for use.

18  Supply of HSD pharmaceutical benefits under this Special Arrangement

(1)   Subject to subsection (2), this Special Arrangement only applies to the supply of an HSD pharmaceutical benefit:

                     (a)  by an approved hospital authority for a public hospital to an eligible patient receiving treatment at or from an approved public hospital; or

                     (b)  by an approved hospital authority for a private hospital to an eligible patient receiving treatment at or from an approved private hospital; or

                     (c)  by an approved pharmacist to an eligible patient receiving treatment at or from a private hospital; or

                     (d)  if the HSD pharmaceutical benefit has a CAR drug—by an approved pharmacist to an eligible patient receiving treatment at or from an approved public hospital or an approved private hospital.

(2)   Where an eligible patient receives treatment in or at or outside of an approved public hospital or an approved private hospital, then a supplier listed in paragraph (a) may supply, to the eligible patient, HSD pharmaceutical benefits that are referred to in paragraph (b):

                     (a)  The suppliers are:

                               i.  an approved pharmacist; or

                              ii.  an approved medical practitioner; or

                             iii.  an approved hospital authority;

                     (b)  The HSD pharmaceutical benefits are:

                               i.  medication for the treatment of hepatitis B;

                              ii.  medication for the treatment of HIV or AIDS, other than the pharmaceutical benefits containing the drugs azithromycin, doxorubicin ‑ pegylated liposomal and rifabutin; and

                             iii.  medication for the treatment of schizophrenia when used in continuing therapy.

(3)   This section does not require an approved hospital authority or an approved pharmacist to supply the HSD pharmaceutical benefit directly to a patient.

(4)   The HSD pharmaceutical benefit may be supplied by the approved hospital authority or approved pharmacist through an agent.

(5)   Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied by an approved hospital authority under this Special Arrangement.

Division 2Repeat prescriptions

19  Application of regulation 25

                   Regulation 25 of the Regulations does not apply to the supply of HSD pharmaceutical benefits.

20  No repeats for visitors

                   An eligible medical practitioner must not write a repeat prescription for an HSD pharmaceutical benefit for a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.

Division 3Prescribing HSD pharmaceutical benefits that have non‑CAR drugs

21  Methods of prescribing HSD pharmaceutical benefits that have non‑CAR drugs

                   An eligible medical practitioner may prescribe an HSD pharmaceutical benefit that has a non‑CAR drug under this Special Arrangement by:

                     (a)  writing a prescription for the HSD pharmaceutical benefit in accordance with regulation 19 of the Regulations; or

                     (b)  preparing a medication chart prescription for the HSD pharmaceutical benefit in accordance with regulation 19AA of the Regulations.

Note:          An eligible medical practitioner may only prescribe more than the maximum quantity or more than the maximum number of repeats of an HSD pharmaceutical benefit that has a non‑CAR drug in accordance with Regulation 13.

22A  Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have non‑CAR drugs

             (1)  If an eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit has a non‑CAR drug, then either the:

                     (a)  eligible medical practitioner; or

                     (b)  approved hospital authority treating the eligible patient;

must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. 

             (2)  These records must be kept for 2 years after the date the prescription to which the records relate is written.

Division 4Prescribing HSD pharmaceutical benefits that have CAR drugs

23  Prescriptions for HSD pharmaceutical benefits that have CAR drugs

                   An eligible medical practitioner may prescribe an HSD pharmaceutical benefit that has a CAR drug by writing a prescription for the HSD pharmaceutical benefit in accordance with regulation 19 of the Regulations.

23A  Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have CAR drugs

             (1)  If an eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit has a CAR drug, then either the:

                     (a)  eligible medical practitioner; or

                     (b)  approved hospital authority treating the eligible patient;

must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. 

             (2)  These records must be kept for 2 years after the date the prescription to which the records relate is written.

24  HSD pharmaceutical benefits that have CAR drugs—quantity exceptions

             (1)  An eligible medical practitioner may write a prescription for an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) to be supplied to an eligible patient on any 1 occasion only in accordance with the limitation mentioned in subsection (2) for each HSD pharmaceutical benefit mentioned in subsection (2).

             (2)  The drugs and limitations are as follows:

                     (a)  for HSD pharmaceutical benefits that have the drug ambrisentan, bosentan, epoprostenol, etanercept, iloprost, sildenafil or tadalafil—a quantity of units sufficient for up to 1 month of treatment with the drug;

                     (b)  for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with severe active rheumatoid arthritis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 3 milligrams per kilogram;

                     (c)  for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with active ankylosing spondylitis, severe active psoriatic arthritis or severe chronic plaque psoriasis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram;

                     (d)  for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of a patient with refractory Crohn disease or fistulating Crohn disease—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram;

                   (da)  for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of a patient with moderate to severe ulcerative colitis—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram.

                   (db)  for HSD pharmaceutical benefits that have the drug infliximab, for the treatment of an adult with severe Crohn disease—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 5 milligrams per kilogram.

                     (e)  for HSD pharmaceutical benefits that have the drug rituximab—a quantity of units sufficient to provide for a single dose;

                      (f)  for HSD pharmaceutical benefits that have the drug abatacept—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose;

                     (g)  for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of adult patients with severe active rheumatoid arthritis—a quantity of units that are sufficient, based on the weight of the patient and taking into account whether any other strength injections will contribute part of the dose, to provide for the whole or part of a single dose of 8 mg per kg;

                     (h)  for HSD pharmaceutical benefits that have the drug adalimumab—a quantity of units that are sufficient, based on the weight of the patient, to provide for 2 doses;

                      (i)  for HSD pharmaceutical benefits that have the drug lenalidomide, for the treatment of a patient with multiple myeloma:

                              (i)  with the form Capsule 5 mg—up to 84 tablets;

                             (ii)  with the form Capsule 10 mg—up to 42 tablets;

                            (iii)  with the form Capsule 15 mg—up to 21 tablets;

                            (iv)  with the form Capsule 25 mg—up to 21 tablets;

                      (j)  for HSD pharmaceutical benefits that have the drug lenalidomide, for the treatment of a patient with myelodysplastic syndrome:

                              (i)  with the form Capsule 5 mg—up to 21 tablets;

                             (ii)  with the form Capsule 10 mg—up to 21 tablets;

                     (k)  for HSD pharmaceutical benefits that have the drug azacitidine with the form Powder for injection 100mg—up to 14 units.

                      (l)  for HSD pharmaceutical benefits that have the drug romiplostim, for initial treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

                              (i)  at the time of the initial written authority application—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;

                             (ii)  during the initial period of dose titration—a quantity of units sufficient to provide for a single dose;

                            (iii)  for a patient whose dose has been stable for a period of 4 weeks—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

                    (m)  for HSD pharmaceutical benefits that have the drug romiplostim, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Romiplostim was commenced:

                              (i)  at the time of the initial written authority application—a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;

                             (ii)  during the initial period of dose titration—a quantity of units sufficient to provide for a single dose;

                            (iii)  for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks;

                            (iv)  for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS‑subsidy—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.

                     (n)  for HSD pharmaceutical benefits that have the drug romiplostim, for the first period of continuing treatment or re‑initiation of interrupted PBS subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS‑subsidised treatment—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks treatment.

                     (o)  for HSD pharmaceutical benefits that have the drug romiplostim, for the second and subsequent periods of continuing treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Romiplostim—a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.

                     (p)  for HSD pharmaceutical benefits that have the drug omalizumab, for initial treatment of uncontrolled severe allergic asthma—a quantity of units that are sufficient to provide for 28 weeks treatment;

                     (q)  for HSD pharmaceutical benefits that have the drug omalizumab, for initial PBS‑subsidised treatment of uncontrolled severe allergic asthma in a patient who has previously received non‑PBS‑subsidised therapy with omalizumab (grandfather patients)—a quantity of units that are sufficient to provide for 24 weeks treatment;

                      (r)  for HSD pharmaceutical benefits that have the drug omalizumab, for continuing treatment—a quantity of units that are sufficient to provide for 24 weeks treatment.

                    (ra)  for HSD pharmaceutical benefits that have the drug omalizumab, for the treatment of severe chronic spontaneous urticaria:

                              (i)  for initial treatment—a quantity of units that are sufficient to provide for 12 weeks treatment;

                             (ii)  for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with omalizumab (grandfathered patients)—a quantity of units that are sufficient to provide for 24 weeks treatment;

                            (iii)  for continuing treatment—a quantity of units that are sufficient to provide for 24 weeks treatment.

                      (s)  for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

                              (i)  with the form Tablet 25 mg (as olamine)—up to 28 tablets;

                             (ii)  with the form Tablet 50 mg (as olamine)—up to 28 tablets;

                            —a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

                      (t)  for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS‑subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Eltrombopag was commenced):

                              (i)  with the form Tablet 25 mg (as olamine)—up to 28 tablets;

                             (ii)  with the form Tablet 50 mg (as olamine)—up to 28 tablets;

                            —a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

                     (u)  for HSD pharmaceutical benefits that have the drug eltrombopag, for the first period of continuing treatment or re‑initiation of interrupted PBS subsidised treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Eltrombopag during the initial period of PBS‑subsidised treatment:

                              (i)  with the form Tablet 25 mg (as olamine)—up to 28 tablets;

                             (ii)  with the form Tablet 50 mg (as olamine)—up to 28 tablets;

                            —a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

                     (v)  for HSD pharmaceutical benefits that have the drug eltrombopag, for the second and subsequent periods of continuing treatment as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Eltrombopag:

                              (i)  with the form Tablet 25 mg (as olamine)—up to 28 tablets;

                             (ii)  with the form Tablet 50 mg (as olamine)—up to 28 tablets;

                            —a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

                    (w)  for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis—a quantity of units sufficient for up to 1 month of treatment with the drug.

                     (x)  for HSD pharmaceutical benefits that have the drug riociguat, for the treatment of Chronic thromboembolic pulmonary hypertension (CTEPH):

                              (i)  for Grandfathered patientsthe maximum quantity authorised will be limited to provide sufficient supply for 1 month.

                             (ii)  for Initial treatmentprescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2‑week intervals to achieve up to a maximum of 2.5 mg three times daily.  Approvals for subsequent authority prescriptions will be limited to 1 month of treatment.

                            (iii)  for Continuing treatmentthe maximum quantity per prescription will be limited to provide sufficient supply for 1 month of treatment.

                     (y)  for HSD pharmaceutical benefits that have the drug riociguat, for balance of supply for patient who has received insufficient therapy with this agent:

                              (i)  for Grandfatheringmaximum of 24 weeks of treatment.

                             (ii)  for Initial treatmentmaximum of 20 weeks of treatment.

                            (iii)  for Continuing treatmentmaximum of 24 weeks of treatment—the treatment must provide no more than the balance up to 20 or 24 weeks of treatment available under the above respective restriction.

                     (z)           for HSD pharmaceutical benefits that have the drug riociguat, for the treatment of Pulmonary arterial hypertension (PAH):

                              (i)  for Initial 1(new patients), Initial 2 (new patients) and Initial 3 (change or re‑commencement of therapy for all patients) – prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2‑week intervals to achieve up to a maximum of 2.5 mg three times daily. Approvals for subsequent authority prescriptions will be limited to 1 month of treatment.

                             (ii)  for Initial 4 (Grandfathered patients), Initial 5 (Grandfathered patients), First Continuing treatment and Subsequent Continuing treatment – the maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment.

                            (iii)  for Initial 1 (new patients) or Initial 2 (new patients) or Initial 3 (change or re‑commencement of therapy for all patients) or First Continuing treatment – Balance of supply – the treatment must provide no more than the balance of up to six months treatment.

                    (za)  for HSD pharmaceutical benefits that have the drug pasireotide, for the treatment of acromegaly:

                              (i)  with the form Injection (modified release) 20 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes;

                             (ii)  with the form Injection (modified release) 40 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes;

                            (iii)  with the form Injection (modified release) 60 mg (as embonate), vial and diluent syringe—up to 2 vials and diluent syringes.

                   (zb)  for HSD pharmaceutical benefits that have the drug pegvisomant, for the treatment of acromegaly:

                              (i)  for initial treatment, for the 80 mg loading dose—4 x injection set containing powder for injection 20 mg, 1 and diluent, 1;

                             (ii)  for initial treatment (subsequent doses)—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30;

                            (iii)  for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with pegvisomant—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30;

                            (iv)  for continuing treatment—1 x injection set containing powder for injection 10 mg, 15 mg or 20 mg, 30 and diluent, 30.

                    (zc)  for HSD pharmaceutical benefits that have the drug ustekinumab, for the treatment of severe Crohn disease:

                              (i)  for initial treatment, for a weight-based loading dose—up to 4 vials of Solution for I.V. infusion 130 mg in 26 mL;

                             (ii)  for a change or re-commencement of treatment, for a weight-based loading dose—up to 4 vials of Solution for I.V. infusion 130 mg in 26 mL.

                   (zd)  for HSD pharmaceutical benefits that have the drug vedolizumab, for the treatment of moderate to severe ulcerative colitis—the appropriate number of vials to provide for a single infusion of 300 mg per dose.

                    (ze)  for HSD pharmaceutical benefits that have the drug vedolizumab, for the treatment of severe Crohn disease— the appropriate number of vials to provide for a single infusion of 300 mg.

25  HSD pharmaceutical benefits that have CAR drugs—repeat exceptions

             (1)  An eligible medical practitioner may authorise the repeat supply of an HSD pharmaceutical benefit that has a CAR drug mentioned in subsection (2) only in accordance with the limitations mentioned in subsection (2) for the drug.

             (2)  The drugs and limitations are as follows:

                     (a)  for bosentan:

                              (i)  if the prescription is for the balance of a 6 month course of initial treatment for a patient who has been issued with an authority prescription for the first month of the 6 month course—up to 4 repeat supplies; or

                             (ii)  if the prescription is for continuing treatment of a patient who has achieved a response to his or her most recent course of PBS‑subsidised treatment—up to 5 repeat supplies;

                     (b)  for etanercept:

                              (i)  for the initial treatment of severe polyarticular course juvenile chronic arthritis—up to 3 repeat supplies; or

                             (ii)  for the continuing treatment of severe polyarticular course juvenile chronic arthritis—up to 5 repeat supplies;

                     (c)  for infliximab, for the treatment of an adult with severe active rheumatoid arthritis:

                              (i)  if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or

                             (ii)  if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;

                     (d)  for infliximab, for the treatment of an adult with severe active psoriatic arthritis:

                              (i)  if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or

                             (ii)  if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;

                     (e)  for infliximab, for the treatment of an adult with active ankylosing spondylitis—up to 3 repeat supplies;

                      (f)  for infliximab, for the treatment of a patient with refractory Crohn disease or fistulating Crohn disease—up to 2 repeat supplies;

                     (g)  for infliximab, for the treatment of an adult with severe chronic plaque psoriasis:

                              (i)  if the circumstances permit a course of up to a maximum of 22 weeks of treatment to be authorised—up to 3 repeat supplies; or

                             (ii)  if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 2 repeat supplies;

                    (ga)  for infliximab, for the treatment of a patient with moderate to severe ulcerative colitis:

                              (i)  for initial treatment (new patient or re-commencement of treatment after more than 5 years break in therapy)—up to 2 repeat supplies;

                             (ii)  for a change or re-commencement of treatment after a break in therapy—up to 2 repeat supplies;

                            (iii)  for continuing treatment—up to 2 repeat supplies.

                   (gb)  for infliximab, for the treatment of an adult with severe Crohn disease:

                              (i)  for initial treatment (new patient – initial 1)—up to 2 repeat supplies;

                             (ii)  for a change or re-commencement of treatment (initial 2)—up to 2 repeat supplies;

                            (iii)  for continuing treatment—up to 2 repeat supplies.

                     (h)  for abatacept, for the treatment of an adult with severe active rheumatoid arthritis:

                              (i)  if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 4 repeat supplies; or

                             (ii)  if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;

                      (i)  for rituximab—1 repeat supply;

                      (j)  for ambrisentan:

                              (i)  for the initial PBS‑subsidised treatment of a patient who was receiving non‑PBS‑subsidised treatment with ambrisentan for less than 6 months before 1 December 2009—sufficient repeat supplies to allow the patient to complete a period of combined PBS‑subsidised and non‑PBS‑subsidised therapy of up to 6 months duration in total; or

                             (ii)  if subparagraph (i) does not apply—up to 5 repeat supplies;

                     (k)  for lenalidomide, for the treatment of a patient with multiple myeloma—up to 2 repeat supplies;

                      (l)  for lenalidomide, for the treatment of a patient with myelodysplastic syndromeup to 3 repeat supplies;

                    (m)  for epoprostenol, iloprost, sildenafil, or tadalafil—up to 5 repeat supplies;

                     (n)  for tocilizumab, for the treatment of adults with severe active rheumatoid arthritis:

                              (i)  if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;

                             (ii)  If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;

                     (o)  for adalimumab for the treatment of a patient with juvenile idiopathic arthritis:

                              (i)  if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;

                             (ii)  if the circumstances permit a course of up to a maximum of 24 weeks treatment to be authorised—up to 5 repeat supplies;

                     (p)  for azacitidine:

                              (i)  for initial treatment—up to 2 repeat supplies;

                             (ii)  for continuing treatment—up to 5 repeat supplies.

                     (q)  for romiplostim for initial treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

                              (i)  at the time of the initial written authority application—1 repeat supply;

                             (ii)  during the initial period of dose titration—1 repeat supply;

                            (iii)  for a patient whose dose has been stable for a period of 4 weeks—up to 4 repeat supplies.

                      (r)  for romiplostim for initial PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with romplostin was commenced:

                              (i)  at the time of the initial written authority application—1 repeat supply;

                             (ii)  during the initial period of dose titration—1 repeat supply;

                            (iii)  for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks—up to 4 repeat supplies;

                            (iv)  for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS‑subsidy—up to 5 repeat supplies.

                      (s)  for romiplostim for the first period of continuing treatment or re‑initiation of interrupted PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS‑subsidised treatment:

                              (i)  at the time of the initial written authority application—up to 5 repeat supplies;

                             (ii)  where less than 5 repeat supplies are requested in the initial written authority application—sufficient repeat supplies to complete a maximum of 24 weeks treatment.

                      (t)  for romiplostim for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with Romiplostim—up to 5 repeat supplies.

                     (u)  for omalizumab—where fewer than the required number of repeats to complete 24 weeks of treatment are requested at the time of the authority application—sufficient repeat supplies to complete 24 weeks of treatment.

                     (v)  for omalizumab—where at least 24 weeks treatment was requested at the time of the application—0 repeat supplies.

                   (va)  for omalizumab, for the treatment of severe chronic spontaneous urticaria:

                              (i)  for initial treatment—where the patient has received a quantity of units that are sufficient to provide for 12 weeks treatment—0 repeat supplies;

                             (ii)  for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with omalizumab (grandfathered patients)—where the patient has received a quantity of units that are sufficient to provide for 24 weeks treatment—0 repeat supplies;

                            (iii)  for continuing treatment—where the patient has received a quantity of units that are sufficient to provide for 24 weeks treatment—0 repeat supplies;

                    (w)  for eltrombopag for initial treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

                              (i)  if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.

                     (x)  for eltrombopag for initial PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with eltrombopag was commenced:

                              (i)  if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.

                     (y)  for eltrombopag for the first period of continuing treatment or re‑initiation of interrupted PBS‑subsidised treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with eltrombopag during the initial period of PBS‑subsidised treatment:

                              (i)  if the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies;

                             (ii)  where less than 5 repeat supplies are requested in the initial written authority application—sufficient repeat supplies to complete a maximum of 24 weeks treatment.

                     (z)  for eltrombopag for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS‑subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with eltrombopag—up to 5 repeat supplies.

                    (za)  for tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis:

                              (i)  if the circumstances permit a course of up to a maximum of 16 weeks of treatment to be authorised—up to 3 repeat supplies;

                             (ii)  If the circumstances permit a course of up to a maximum of 24 weeks of treatment to be authorised—up to 5 repeat supplies.

                   (zb)  for riociguat, for the treatment of Chronic thromboembolic pulmonary hypertension (CTEPH):

                              (i)  for grandfatheringup to 5 repeat supplies.

                             (ii)  for initial treatmentup to 3 repeat supplies.

                            (iii)  for continuing treatmentup to 5 repeat supplies.

                    (zc)  for riociguat, for the treatment of Pulmonary arterial hypertension (PAH):

                              (i)  for Initial 1 (new patients), Initial 2 (new patients) and Initial 3 (change or re‑commencement of therapy for all patients) – up to 4 repeat supplies.

                             (ii)  for Initial 4 (Grandfathered patients), Initial 5 (Grandfathered patients), First Continuing treatment and Subsequent Continuing treatment – up to 5 repeat supplies.

                   (zd)  for pasireotide—up to 5 repeat supplies.

                    (ze)  for pegvisomant:

                              (i)  for initial treatment, for the 80 mg loading dose—0 repeat supplies;

                             (ii)  for intitial treatment (subsequent doses)—up to 5 repeat supplies;

                            (iii)  for initial PBS-subsidised treatment in a patient who has previously received non-PBS-subsidised therapy with pegvisomant—up to 5 repeat supplies;

                            (iv)  for continuing treatment—up to 5 repeat supplies.

                    (zf)  for ustekinumab:

                              (i)  for initial treatment, for a weight-based loading dose—0 repeat supplies;

                             (ii)  for a change or re-commencement of treatment, for a weight-based loading dose——0 repeat supplies.

                    (zg)  for vedolizumab, for the treatment of severe Crohn disease:

                              (i)  for initial treatment (new patient – initial 1)—up to 2 repeat supplies;

                             (ii)  for a change or re-commencement of treatment (initial 2)—up to 2 repeat supplies;

                            (iii)  for initial PBS-subsidised treatment (grandfather)—up to 2 repeat supplies;

                            (iv)  for continuing treatment—up to 2 repeat supplies.

                   (zh)  for vedolizumab, for the treatment of moderate to severe ulcerative colitis:

                              (i)  for initial treatment (new patient – initial 1)—up to 2 repeat supplies;

                             (ii)  for a change or re-commencement of treatment after a break in therapy (initial 2)—up to 2 repeat supplies;

                            (iii)  for initial PBS-subsidised treatment (grandfather patient)—up to 2 repeat supplies;

                            (iv)  for continuing treatment—up to 2 repeat supplies.

             (3)  In this section, circumstances means circumstances mentioned in Schedule 3 for the circumstances code mentioned in the column in Schedule 1 headed ‘Circumstances’ for the HSD pharmaceutical benefit that has the drug.

26  Application of regulation 13 in relation to CAR drugs

                   Regulation 13 of the Regulations does not apply in relation to a prescription for an HSD pharmaceutical benefit that has a CAR drug supplied under this Special Arrangement.

Part 4Claiming procedures and payment amounts

Division 2Modified section 99AAA claims by approved public hospitals

Subdivision 1General requirements

30  How claims to be made—modified section 99AAA claiming

                   An approved hospital authority for a public hospital may make a claim for payment for the supply of an HSD pharmaceutical benefit in accordance with the rules made by the Minister under subsection 99AAA(8) of the Act, as modified by this Division.

Note 1:       An approved hospital authority for a public hospital that may make a modified section 99AAA claim may choose instead to make the claim in accordance with the rules made by the Minister under subsection 99AAA(8) of the Act.

31  Limit on number of prescriptions in one claim

                   The claim for payment must not contain more than 3 500 prescriptions.

Subdivision 3Payment of claims

35  Payments to suppliers that are approved hospital authorities for public hospitals

             (1)  An approved hospital authority for a public hospital is entitled to be paid the amount, if any, by which the dispensed price for the supply of the HSD pharmaceutical benefit exceeds the amount that the approved hospital authority was entitled to charge under subsection 46(2).

             (2)  The dispensed price is to be worked out in accordance with Division 1 of Part 5.

             (3)  No mark ups may be added to the cost of an HSD pharmaceutical benefit for which payment is claimed under this Division.

Division 3Payments to suppliers of HSD pharmaceutical benefits that are approved hospital authorities for private hospitals or approved pharmacists or approved medical practitioners

36  Payments to certain suppliers of HSD pharmaceutical benefits

             (1)  An approved hospital authority for a private hospital is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for its supply of the HSD pharmaceutical benefit is greater than the amount that the approved hospital authority was entitled to charge under subsection 46(2).

             (2)  An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of an HSD pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under subsection 47(2).

             (3)  The dispensed price for the supply of an HSD pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or by an approved medical practitioner is to be worked out under Division 2 of Part 5.

Note:          An approved hospital authority for a private hospital or an approved pharmacist may make claims for payment in accordance with rules made by the Minister under subsection 99AAA(8) of the Act—see section 99AAA(2) of the Act.

Part 5Dispensed price

Division 1Dispensed price for supply of an HSD pharmaceutical benefit by a hospital authority for a public hospital

37  The dispensed price—supply by public hospital

                   Subject to section 43, the dispensed price for the supply of an HSD pharmaceutical benefit, by a hospital authority for a public hospital, is as follows:

                     (a)  if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity of the benefit—the sum of the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity;

                     (b)  if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit—the amount calculated in accordance with section 38;

                     (c)  if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity of the benefit—the sum of:

                              (i)  the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity; and

                             (ii)  the amount calculated in accordance with section 38 for the remainder of the quantity supplied that is less than a pack quantity.

38  Where quantity is less than a pack quantity

                   If the quantity of an HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in paragraph 37(b) and subparagraph 37(c)(ii) is to be calculated by:

                     (a)  dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

                     (b)  applying that percentage to the approved ex‑manufacturer price or proportional ex‑manufacturer price for the pack quantity.

Division 2Dispensed price for supply of HSD pharmaceutical benefit by an approved hospital authority for a private hospital or by an approved pharmacist or approved medical practitioner

39  The dispensed price—supply by an approved hospital authority for a private hospital or by an approved pharmacist or approved medical practitioner

             (1)  The dispensed price for the supply of an HSD pharmaceutical benefit by an approved hospital authority for a private hospital, or by an approved pharmacist, or by an approved medical practitioner, is as follows:

                     (a)  if the quantity of the HSD pharmaceutical benefit that is ordered and supplied is equal to a multiple of a pack quantity, the sum of:

                              (i)  the approved ex‑manufacturer price or the proportional ex‑manufacturer price for each pack quantity, plus the mark‑up mentioned in section 40, taken to the nearest cent, with one half cent being rounded up to 1 cent; and

                             (ii)  either:

                                        (A)  a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or

                                        (B)  if the HSD pharmaceutical benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee mentioned in the the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or

                     (b)  if a quantity of the HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity, the sum of:

                              (i)  the amount calculated in accordance with section 41; and

                             (ii)  either:

                                        (A)  a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or

                                        (B)  if the HSD pharmaceutical benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee mentioned in the the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or

                     (c)  if a quantity of the HSD pharmaceutical benefit that is ordered and supplied is more than a multiple of a pack quantity, the sum of:

                              (i)  for each pack quantity, the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, plus the mark‑up mentioned in section 40, taken to the nearest cent, with one half cent being counted as 1 cent; and

                             (ii)  the amount calculated in accordance with section 41 for the remainder of the quantity supplied that is less than a pack quantity; and

                            (iii)  either:

                                        (A)  a dispensing fee equal to the dispensing fee for the supply of a ready prepared pharmaceutical benefit, mentioned in the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit; or

                                        (B)  if the HSD pharmaceutical benefit has the drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee set out in the the determination made under paragraph 98B(1)(a) of the Act, as in force at the time of the supply of the HSD pharmaceutical benefit.

             (2)  For sub‑subparagraphs (1)(a)(ii)(B), (1)(b)(ii)(B) and (1)(c)(iii)(B), the drugs and the forms for the drugs are as follows:

                     (a)  mycophenolic acid as a powder for oral suspension containing mycophenolate mofetil 1g per 5 mL, 165mL;

                     (c)  valganciclovir as a powder for oral solution 50mg (as hydrocholoride) per mL, 100 mL.

40  Mark‑up

                   For subparagraphs 39(1)(a)(i) and 39(1)(c)(i) and paragraph 41(a), the mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is:

                     (a)  if the pack quantity for which a mark‑up is to be calculated under this section is equal to a maximum quantity of the HSD pharmaceutical benefit, the mark‑up is the amount mentioned in the table below for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer price (PEMP) for that quantity. 

 

Item

AEMP or PEMP for Maximum Quantity

Mark‑up for Maximum Quantity

1

< $40

10% of  AEMP or PEMP

2

≥ $40, ≤ $100

$4.00

3

> $100, ≤ $1,000

4% of AEMP or PEMP

4

> $1,000

$40.00

 

                     (b)  if the pack quantity for which a mark‑up is to be calculated under this section is not equal to a maximum quantity of the HSD pharmaceutical benefit, the mark‑up is worked out as follows:

                              (i)  if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a monetary amount—the mark‑up for the pack quantity is that monetary amount reduced proportionately for the relative quantities; and

                             (ii)  if the mark‑up that would apply to the maximum quantity is shown in the table in paragraph (a) as a percentage of AEMP or PEMP—the mark‑up for the pack quantity is that percentage of the AEMP or PEMP for the pack quantity.

41  Where quantity is less than a pack quantity

                   If the quantity of an HSD pharmaceutical benefit that is ordered and supplied is less than a pack quantity of the benefit (a broken quantity), the amount mentioned in subparagraph 39(b)(i) and 39(c)(ii) is to be calculated by:

                     (a)  adding the mark‑up mentioned in section 40 to the approved ex‑manufacturer price or the proportional ex‑manufacturer price for the pack quantity, taking the result to the nearest cent, with one half cent being counted as 1 cent; and

                     (b) dividing the quantity or number of units in the broken quantity by the pack quantity, expressed as a percentage to 2 decimal places; and

                     (c)  applying the percentage worked out under subparagraph (b) to the amount worked out under subparagraph (a).

42  Dispensing fee

                   If an eligible medical practitioner, instead of directing a repeated supply of an HSD pharmaceutical benefit, directs the supply on one occasion of a quantity or number of units of the drug, not exceeding the total quantity or number of units that could be prescribed if the eligible medical practitioner directed a repeated supply, the dispensed price for the supply of the HSD pharmaceutical benefit will include only one dispensing fee.

Division 3Dispensed price—other matters

44  Rounding up of dispensed price

                   The dispensed price for the supply of an HSD pharmaceutical benefit will in each case be taken to the nearest cent, one half cent being counted as one cent.

Part 6Patient contributions

  

46  Patient contributions in relation to approved hospital authorities

             (1)  This section applies to an approved hospital authority for a public hospital or a private hospital that supplies an HSD pharmaceutical benefit.

             (2)  The approved hospital authority may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.

             (3)  For section 87 of the Act, the amount that is equal to the special patient contribution for the supply of an HSD pharmaceutical benefit that is a brand of a pharmaceutical item is the amount mentioned in section 48 if the HSD pharmaceutical benefit is mentioned in Schedule 4.

47  Patient contributions for claims by approved pharmacists or approved medical practitioners

             (1)  This section applies if an approved pharmacists or an approved medical practitioner supplies an HSD pharmaceutical benefit to an eligible patient and makes a claim for payment.

             (2)  The approved pharmacist or the approved medical practitioner may charge the patient an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the patient.

             (3)  For section 87 of the Act, the amount that is equal to the special patient contribution for the supply of an HSD pharmaceutical benefit that is a brand of a pharmaceutical item is the amount mentioned in section 48 if the HSD pharmaceutical benefit is mentioned in Schedule 4.

48  Additional patient contributions

                   For subsections 46(3) and 47(3), the amount is the amount that is the difference between:

                     (a)  the price that would have been the dispensed price for the quantity of the HSD pharmaceutical benefit supplied if that dispensed price had been based on the claimed price mentioned for the benefit in the column in Schedule 4 headed ‘Claimed Price’; and

                     (b)  the dispensed price for that quantity of the HSD pharmaceutical benefit.

 

Part 7Miscellaneous

  

49  Compliance and audit arrangements

             (1)  If an approved supplier supplies HSD pharmaceutical benefits under this Special Arrangement, the approved supplier that supplies the HSD pharmaceutical benefits must keep adequate, secure and auditable records of all supplied HSD pharmaceutical benefits for which a claim is made.

             (2)  The records must be kept in systems that are able to be audited by the Chief Executive Medicare on reasonable notice being given to the approved supplier.

50  PBS Safety Net

             (2)  An amount paid by a person because of a charge made by an approved hospital authority under subsection 46(2) counts towards the person’s PBS safety net if it is equivalent to the amount chargeable under subsection 87(5) of the Act for the supply of the HSD pharmaceutical benefit less the amount chargeable under that subsection because of subsection 87(2A) of the Act.

             (3)  An amount paid by a person because of a charge made by an approved pharmacist or approved medical practitioner under subsection 47(2) counts towards the person’s PBS safety net, other than an amount equivalent to the amount chargeable under subsection 87(2A) of the Act for the supply of the HSD pharmaceutical benefit to the person.

Note:          Division 1A of Part VII of the Act contains provisions about safety net concession cards.

51  Application of Act and Part VII instruments to approved suppliers and prescriptions etc

                   For the application of Part VII of the Act, or of regulations or other instruments made for Part VII of the Act:

                     (a)  a reference in the Act or other instrument to an approved supplier or an approved hospital authority includes a reference to a hospital authority approved under:

                              (i) subsection 52(2) of this Special Arrangement; or

                             (ii)  subsection 52(2) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010); and

                     (b)  a reference in the Act or other instrument to a number allotted to an approval under regulation 8A includes a reference to a number allotted to an approval under:

                              (i)  subsection 52(3) of this Special Arrangement; and

                             (ii)  subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010); and

                     (c)  a medication chart prescription may be written for an eligible patient receiving treatment from a hospital; and

                      (f) the rules made under subsection 98AC(4) of the Act apply to a supply of a HSD pharmaceutical benefit by an approved pharmacist, approved medical practitioner or approved hospital authority for a hospital under this Special Arrangement as if the definition of under co‑payment data appearing in those rules was replaced with the definition of under co‑payment data in section 4 of this Special Arrangement.

Note 1:       Section 84 of the Act defines approved hospital authority and approved supplier for Part VII of the Act.

Note 2:       The rules made by the Minister under subsection 99AAA(8) of the Act are instruments made under Part VII of the Act.

Part 8Approval of certain hospital authorities

  

52  Approval of certain public hospital authorities

             (1)  A hospital authority for a public hospital, that must not be approved under section 94 of the Act because of subsection 94(5) of the Act, may apply, in writing, to the Chief Executive Medicare for approval under this Part for the purpose of its supplying HSD pharmaceutical benefits under this Special Arrangement to eligible patients receiving treatment at or from the hospital of which it is the governing body.

             (2)  The Chief Executive Medicare may, in writing, approve the hospital authority for this Special Arrangement.

             (3)  If the Chief Executive Medicare approves the hospital authority, he or she may allot a number to the approval.

             (4)  A number allotted to a hospital authority under either of the following provisions is to be treated as having been allotted by the Secretary under subregulation 8A (1) of the Regulations:

                     (a)  subsection (3) of this section;

                     (b)  subsection 52(3) of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010.

             (5)  The approval may be subject to any conditions the Chief Executive Medicare determines.

             (6)  The Chief Executive Medicare must, in writing, notify the hospital authority of his or her decision on the hospital authority’s application.

             (7)  The Chief Executive Medicare may, at any time, by notice in writing to the hospital authority, vary, suspend or revoke the approval.

Note:          An approval under this Part may only be made for a hospital authority for a public hospital and does not constitute an approval under section 94 of the Act.

Part 9Transitional arrangements

  

53  Approvals of certain hospital authorities of public hospitals

                   Despite the revocation of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010), an approval that was in force under subsection 52(2) of that Instrument immediately before the commencement of this section continues in force under this Special Arrangement as if it were an approval under subsection 52(2) of this Special Arrangement.

54  Transitional arrangements for existing public hospital medication chart prescribing and paperless claiming

             (1)  An eligible medical practitioner at a public hospital may prescribe a HSD pharmaceutical benefit that has a non‑CAR drug under this Special Arrangement, before 1 April 2017, by following the requirements for prescribing from a medication chart in the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015.

             (2)  An approved hospital authority for a public hospital can supply a HSD pharmaceutical benefit prescribed under subsection (1).

             (3)  The requirements for prescribing, supplying and claiming from a medication chart set out in the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015, continue to apply in relation to a medication chart prepared under subsection (1).

             (4)  However, this section does not apply if the public hospital referred to in subsections (1) and (2) is a listed approved hospital under regulation 59 of the Regulations.

             (5)  However, if this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules. 

55  Transitional arrangements for existing non‑medication chart public hospital paperless claiming

             (1)  An approved hospital authority for a public hospital may supply a HSD pharmaceutical benefit that has a non‑CAR drug before 1 April 2017, from a prescription other than a medication chart, in accordance with Part 4, Division 2, Subdivision 2 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015.

             (2)  However, if this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules.

56  Transitional arrangements for repeat prescriptions

             (1)  Where an authorised prescriber has issued a repeat prescription prior to 1 July 2015, the new arrangements apply to the supply of the repeat pharmaceutical benefits.

             (2)  In this section new arrangements mean the National Health (Highly specialised drugs program) Special Arrangement 2010 as in force on 1 July 2015.


Schedule 1Pharmaceutical benefits covered by this Special Arrangement and related information

(sections 5, 7, 8, 9, 10, 14, 15, 16 and 25)

  

 

Listed Drug

Form

Manner of Administration

Brand

Responsible Person

Authorised Prescriber

Circumstances

Purposes

Maximum Quantity

Number of Repeats

Section 100 only

Abacavir

Tablet 300 mg (as sulfate)

Oral

Ziagen

VI

EMP

C4454 C4512

 

120

5

D

 

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

Oral

Ziagen

VI

EMP

C4454 C4512

 

8

5

D

Abacavir with Lamivudine

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

Oral

Abacavir/Lamivudine GH 600/300

GQ

EMP

C4527 C4528

 

60

5

D

 

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

Oral

Kivexa

VI

EMP

C4527 C4528

 

60

5

D

Abacavir with Lamivudine and Zidovudine

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

Oral

Trizivir

VI

EMP

C4480 C4495

 

120

5

D

Abatacept

Powder for I.V. infusion 250 mg

Injection

Orencia

BQ

EMP

C4695 C4734 C6900 C6908 C6927

 

See Note 1

See Note 2

PB

Adalimumab

Injection 20 mg in 0.4 mL pre‑filled syringe

Injection

Humira

VE

EMP

C4464 C4465 C4491 C4500 C4546

 

See Note 1

See Note 2

C

 

Injection 40 mg in 0.8 mL pre‑filled syringe

Injection

Humira

VE

EMP

C4464 C4465 C4491 C4500 C4546

 

See Note 1

See Note 2

C

 

Injection 40 mg in 0.8 mL pre‑filled pen

Injection

Humira

VE

EMP

C4464 C4465 C4491 C4500 C4546

 

See Note 1

See Note 2

C

Adefovir

Tablet containing adefovir dipivoxil 10 mg

Oral

APO‑Adefovir

TX

EMP

C4490 C4510

 

60

5

D

 

 

 

Hepsera

GI

EMP

C4490 C4510

 

60

5

D

Alemtuzumab

Solution concentrate for I.V. infusion 12 mg in 1.2 mL

Injection

Lemtrada

GZ

EMP

C6847 C6877 C6878 C6884

P6847 P6878

3

0

D

 

 

 

 

 

EMP

C6847 C6877 C6878 C6884

P6877 P6884

5

0

D

Ambrisentan

Tablet 5 mg

Oral

Volibris

GK

EMP

C6089 C6711 C6722 C6734 C6748 C6765

 

See Note 1

See Note 2

D

 

Tablet 10 mg

Oral

Volibris

GK

EMP

C6089 C6711 C6722 C6734 C6748 C6765

 

See Note 1

See Note 2

D

Anakinra

Injection 100 mg in 0.67 mL single use pre‑filled syringe

Injection

Kineret

FK

EMP

C5450

 

28

5

D

Apomorphine

Injection containing apomorphine hydrochloride 20 mg in 2 mL

Injection

Movapo

TD

EMP

C4833 C4860

 

360

5

D

 

Injection containing apomorphine hydrochloride 50 mg in 5 mL

Injection

Movapo

TD

EMP

C4833 C4860

 

180

5

D

 

Injection containing apomorphine hydrochloride 100 mg in 20 mL

Injection

Apomine Solution for Infusion

PF

EMP

C4860 C6813

 

90

5

D

 

Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre‑filled syringe

Injection

Movapo PFS

TD

EMP

C4833 C4860

 

180

5

D

Atazanavir

Capsule 150 mg (as sulfate)

Oral

Reyataz

BQ

EMP

C4454 C4512

 

120

5

D

 

Capsule 200 mg (as sulfate)

Oral

Reyataz

BQ

EMP

C4454 C4512

 

120

5

D

 

Capsule 300 mg (as sulfate)

Oral

Reyataz

BQ

EMP

C4454 C4512

 

60

5

D

Atazanavir with cobicistat

Tablet containing 300 mg atazanavir and 150 mg cobicistat

Oral

Evotaz

BQ

EMP

C4454 C4512

 

60

5

D

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine Accord

OC

EMP

C6132 C6143 C6144 C6177 C6186 C6199

 

See Note 1

See Note 2

D

 

 

 

AZACITIDINE DR.REDDY’S

RI

EMP

C6132 C6143 C6144 C6177 C6186 C6199

 

See Note 1

See Note 2

D

 

 

 

Azadine

RZ

EMP

C6132 C6143 C6144 C6177 C6186 C6199

 

See Note 1

See Note 2

D

 

 

 

Celazadine

JU

EMP

C6132 C6143 C6144 C6177 C6186 C6199

 

See Note 1

See Note 2

D

 

 

 

Vidaza

CJ

EMP

C6132 C6143 C6144 C6177 C6186 C6199

 

See Note 1

See Note 2

D

Azithromycin

Tablet 600 mg (as dihydrate)

Oral

Zithromax

PF

EMP

C6356 C6361

 

16

5

PB

Baclofen

Intrathecal injection 10 mg in 5 mL

Injection

Bacthecal

DZ

EMP

C6911 C6912 C6925 C6929 C6930 C6935 C6939 C6940

 

10

0

PB

 

 

 

Lioresal Intrathecal

NV

EMP

C6911 C6912 C6925 C6929 C6930 C6935 C6939 C6940

 

10

0

PB

 

 

 

Sintetica Baclofen Intrathecal

BZ

EMP

C6911 C6912 C6925 C6929 C6930 C6935 C6939 C6940

 

10

0

PB

 

Intrathecal injection 40 mg in 20 mL

Injection

Sintetica Baclofen Intrathecal

BZ

EMP

C7134 C7148 C7152 C7153 C7156 C7157 C7159 C7162

 

2

0

PB

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

Bosentan APOTEX

TX

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Bosentan Mylan

AF

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Bosentan RBX

RA

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Bosentan Sandoz

SZ

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

BOSENTAN‑DRLA

RZ

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

BOSLEER

RW

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Tracleer

AT

EMP

C4628 C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

Tablet 125 mg (as monohydrate)

Oral

Bosentan APOTEX

TX

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Bosentan GH

GQ

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Bosentan Mylan

AF

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Bosentan RBX

RA

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Bosentan Sandoz

SZ

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

BOSENTAN‑DRLA

RZ

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

BOSLEER

RW

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

 

 

 

Tracleer

AT

EMP

C6089 C6710 C6734 C6748 C6764 C6776

 

See Note 1

See Note 2

D

Clarithromycin

Tablet 500 mg

Oral

APO Clarithromycin

TX

EMP

C5873 C5874

 

100

2

PB

Clozapine

Tablet 25 mg

Oral

Clopine 25

PF

EMP

C4998 C5001 C5015

 

200

0

D

 

 

 

Clozaril 25

GO

EMP

C4998 C5001 C5015

 

200

0

D

 

Tablet 50 mg

Oral

Clopine 50

PF

EMP

C4998 C5001 C5015

 

200

0

D

 

Tablet 100 mg

Oral

Clopine 100

PF

EMP

C4998 C5001 C5015

 

200

0

D

 

 

 

Clozaril 100

GO

EMP

C4998 C5001 C5015

 

200

0

D

 

Tablet 200 mg

Oral

Clopine 200

PF

EMP

C4998 C5001 C5015

 

200

0

D

 

Oral liquid 50 mg per mL, 100 mL

Oral

Clopine Suspension

PF

EMP

C4998 C5001 C5015

 

1

0

D

Cyclosporin

Capsule 10 mg

Oral

Neoral 10

NV

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

120

5

C

 

Capsule 25 mg

Oral

Cyclosporin Sandoz

SZ

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

120

5

C

 

 

 

Neoral 25

NV

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

120

5

C

 

Capsule 50 mg

Oral

Cyclosporin Sandoz

SZ

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

120

5

C

 

 

 

Neoral 50

NV

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

120

5

C

 

Capsule 100 mg

Oral

Cyclosporin Sandoz

SZ

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

120

5

C

 

 

 

Neoral 100

NV

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

120

5

C

 

Oral liquid 100 mg per mL, 50 mL

Oral

Neoral

NV

EMP

C6629 C6630 C6631 C6638 C6643 C6659 C6660 C6670 C6671 C6676

 

4

5

C

 

Solution concentrate for I.V. infusion    50 mg in 1 mL

Injection

Sandimmun

NV

EMP

C6628 C6677

 

10

0

PB

Daclatasvir

Tablet 30 mg

Oral

Daklinza

BQ

EMP

C5969 C5972

P5969

28

2

 

 

 

 

 

 

EMP

C5969 C5972

P5972

28

5

 

 

Tablet 60 mg

Oral

Daklinza

BQ

EMP

C5969 C5972

P5969

28

2

 

 

 

 

 

 

EMP

C5969 C5972

P5972

28

5

 

Darbepoetin Alfa

Injection 10 micrograms in 0.4 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 20 micrograms in 0.5 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 20 micrograms in 0.5 mL pre‑filled injection pen

Injection

Aranesp SureClick

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 30 micrograms in 0.3 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 40 micrograms in 0.4 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 40 micrograms in 0.4 mL pre‑filled injection pen

Injection

Aranesp SureClick

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 50 micrograms in 0.5 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 60 micrograms in 0.3 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 60 micrograms in 0.3 mL pre‑filled injection pen

Injection

Aranesp SureClick

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 80 micrograms in 0.4 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 80 micrograms in 0.4 mL pre‑filled injection pen

Injection

Aranesp SureClick

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 100 micrograms in 0.5 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 100 micrograms in 0.5 mL pre‑filled injection pen

Injection

Aranesp SureClick

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 150 micrograms in 0.3 mL pre‑filled syringe

Injection

Aranesp

AN

EMP

C6260 C6294

 

8

5

D

 

Injection 150 micrograms in 0.3 mL pre‑filled injection pen

Injection

Aranesp SureClick

AN

EMP

C6260 C6294

 

8

5

D

Darunavir

Tablet 150 mg (as ethanolate)

Oral

Prezista

JC

EMP

C5094

 

240

5

D

 

Tablet 600 mg (as ethanolate)

Oral

Prezista

JC

EMP

C5094

 

120

5

D

 

Tablet 800mg (as ethanolate)

Oral

Prezista

JC

EMP

C4313

 

60

5

D

Darunavir with cobicistat

Tablet containing darunavir 800mg with cobicistat 150 mg

Oral

Prezcobix

JC

EMP

C6377 C6413 C6428

 

60

5

D

 

Deferasirox

Tablet, dispersible, 125 mg

Oral

Exjade

NV

EMP

C6420 C6432

 

168

5

D

 

Tablet, dispersible, 250 mg

Oral

Exjade

NV

EMP

C6420 C6432

 

168

5

D

 

Tablet, dispersible, 500 mg

Oral

Exjade

NV

EMP

C6420 C6432

 

168

5

D

Deferiprone

Tablet 500 mg

Oral

Ferriprox

TX

EMP

C6380 C6403 C6442 C6448

 

600

5

D

 

Oral solution 100 mg per mL, 250 mL

Oral

Ferriprox

TX

EMP

C6380 C6403 C6442 C6448

 

5

5

D

Desferrioxamine

Powder for injection containing desferrioxamine mesylate 500 mg

Injection

Hospira Pty Limited

PF

EMP

C6394 C6408

 

400

5

D

 

Powder for injection containing desferrioxamine mesylate 2 g

Injection

Hospira Pty Limited

PF

EMP

C6394 C6408

 

60

5

D

Didanosine

Capsule 250 mg (containing enteric coated beadlets)

Oral

Videx EC

BQ

EMP

C4454 C4512

 

60

5

D

 

Capsule 400 mg (containing enteric coated beadlets)

Oral

Videx EC

BQ

EMP

C4454 C4512

 

60

5

D

Dolutegravir

Tablet 50mg (as sodium)

Oral

Tivicay

VI

EMP

C4454 C4512

 

60

5

D

Dolutegravir with abacavir and lamivudine

Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg

Oral

Triumeq

VI

EMP

C4480 C4495

 

60

5

D

Dornase Alfa

Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL

Inhalation

Pulmozyme

RO

EMP

C5634 C5635 C5715 C5740 C5768 C5800

 

60

5

D

Doxorubicin ‑
Pegylated Liposomal

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

Injection

Caelyx

JC

EMP

C6233 C6234 C6264 C6274

 

4

5

D

 

 

 

Liposomal Doxorubicin SUN

RA

EMP

C6233 C6234 C6264 C6274

 

4

5

D

Eculizumab

Solution concentrate for I.V. infusion  300 mg in 30 mL

Injection

Soliris

XI

EMP

C6626 C6637 C6642 C6668 C6686 C6687 C6688

P6626

1

0

D

 

 

 

 

 

 

C6626 C6637 C6642 C6668 C6686 C6687 C6688

P6642

1

4

D

 

 

 

 

 

 

C6626 C6637 C6642 C6668 C6686 C6687 C6688

P6668 P6686

P6687 P6688

1

5

D

 

 

 

 

 

 

C6626 C6637 C6642 C6668 C6686 C6687 C6688

P6637

1

6

D

Efavirenz

Tablet 200 mg

Oral

Stocrin

MK

EMP

C4454 C4512

 

180

5

D

 

Tablet 600 mg

Oral

Stocrin

MK

EMP

C4454 C4512

 

60

5

D

 

Oral solution 30 mg per mL, 180 mL

Oral

Stocrin

MK

EMP

C4454 C4512

 

7

5

D

Eltrombopag

Tablet 25 mg (as olamine)

Oral

Revolade

NV

EMP

C6724 C6725 C6738 C6739 C6790

 

See Note 1

See Note 2

D

 

Tablet 50 mg (as olamine)

Oral

Revolade

NV

EMP

C6724 C6725 C6738 C6739 C6790

 

See Note 1

See Note 2

D

Emtricitabine

Capsule 200 mg

Oral

Emtriva

GI

EMP

C4454 C4512

 

60

5

D

Emtricitabine with rilpivirine with tenofovir alafenamide

Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg

Oral

Odefsey

GI

EMP

C4470 C4522

 

60

5

D

Emtricitabine with tenofovir alafenamide

Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg

Oral

Descovy

GI

EMP

C4454 C4512

 

60

5

D

 

Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg

Oral

Descovy

GI

EMP

C4454 C4512

 

60

5

D

Enfuvirtide

Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)

Injection

Fuzeon

RO

EMP

C5014

 

2

5

D

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

Baraclude

BQ

EMP

C4993 C5036

 

60

5

D

 

 

 

ENTAC

LR

EMP

C4993 C5036

 

60

5

D

 

 

 

Entecavir Amneal

EA

EMP

C4993 C5036

 

60

5

D

 

 

 

Entecavir APOTEX

TX

EMP

C4993 C5036

 

60

5

D

 

 

 

Entecavir GH

GQ

EMP

C4993 C5036

 

60

5

D

 

 

 

Entecavir Mylan

AF

EMP

C4993 C5036

 

60

5

D

 

 

 

ENTECAVIR RBX

RA

EMP

C4993 C5036

 

60

5

D

 

 

 

Entecavir Sandoz

SZ

EMP

C4993 C5036

 

60

5

D

 

 

 

ENTECLUDE

RW

EMP

C4993 C5036

 

60

5

D

 

Tablet 1 mg (as monohydrate)

Oral

Baraclude

BQ

EMP

C5037 C5044

 

60

5

D

 

 

 

ENTAC

LR

EMP

C5037 C5044

 

60

5

D

 

 

 

Entecavir Amneal

EA

EMP

C5037 C5044

 

60

5

D

 

 

 

Entecavir APOTEX

TX

EMP

C5037 C5044

 

60

5

D

 

 

 

Entecavir GH

GQ

EMP

C5037 C5044

 

60

5

D

 

 

 

Entecavir Mylan

AF

EMP

C5037 C5044

 

60

5

D

 

 

 

ENTECAVIR RBX

RA

EMP

C5037 C5044

 

60

5

D

 

 

 

Entecavir Sandoz

SZ

EMP

C5037 C5044

 

60

5

D

 

 

 

ENTECLUDE

RW

EMP

C5037 C5044

 

60

5

D

Epoetin Alfa

Injection 1,000 units in 0.5 mL pre‑filled syringe

Injection

Eprex 1000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 2,000 units in 0.5 mL pre‑filled syringe

Injection

Eprex 2000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 3,000 units in 0.3 mL pre‑filled syringe

Injection

Eprex 3000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 4,000 units in 0.4 mL pre‑filled syringe

Injection

Eprex 4000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 5,000 units in 0.5 mL pre‑filled syringe

Injection

Eprex 5000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 6,000 units in 0.6 mL pre‑filled syringe

Injection

Eprex 6000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 8,000 units in 0.8 mL pre‑filled syringe

Injection

Eprex 8000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 10,000 units in 1 mL pre‑filled syringe

Injection

Eprex 10000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 20,000 units in 0.5 mL pre‑filled syringe

Injection

Eprex 20,000

JC

EMP

C6260 C6294

 

12

5

D

 

Injection 40,000 units in 1 mL pre‑filled syringe

Injection

Eprex 40,000

JC

EMP

C6260 C6294

 

2

5

D

Epoetin Beta

Injection 2,000 units in 0.3 mL pre‑filled syringe

Injection

NeoRecormon

RO

EMP

C6260 C6294

 

12

5

D

 

Injection 3,000 units in 0.3 mL pre‑filled syringe

Injection

NeoRecormon

RO

EMP

C6260 C6294

 

12

5

D

 

Injection 4,000 units in 0.3 mL pre‑filled syringe

Injection

NeoRecormon

RO

EMP

C6260 C6294

 

12

5

D

 

Injection 5,000 units in 0.3 mL pre‑filled syringe

Injection

NeoRecormon

RO

EMP

C6260 C6294

 

12

5

D

 

Injection 6,000 units in 0.3 mL pre‑filled syringe

Injection

NeoRecormon

RO

EMP

C6260 C6294

 

12

5

D

 

Injection 10,000 units in 0.6 mL pre‑filled syringe

Injection

NeoRecormon

RO

EMP

C6260 C6294

 

12

5

D

Epoetin lambda

Injection 1,000 units in 0.5 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

 

Injection 2,000 units in 1 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

 

Injection 3,000 units in 0.3 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

 

Injection 4,000 units in 0.4 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

 

Injection 5,000 units in 0.5 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

 

Injection 6,000 units in 0.6 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

 

Injection 8,000 units in 0.8 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

 

Injection 10,000 units in 1 mL pre‑filled syringe

Injection

Novicrit

SZ

EMP

C6260 C6294

 

12

5

D

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium)

Injection

Veletri

AT

EMP

C6123 C6734 C6748 C6945 C6955

 

See Note 1

See Note 2

D

 

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

GK

EMP

C6123 C6734 C6748 C6945 C6955

 

See Note 1

See Note 2

D

 

Powder for I.V. infusion 1.5 mg (as sodium)

Injection

Veletri

AT

EMP

C6123 C6734 C6748 C6945 C6955

 

See Note 1

See Note 2

D

 

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

GK

EMP

C6123 C6734 C6748 C6945 C6955

 

See Note 1

See Note 2

D

Etanercept

Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL

Injection

Enbrel

PF

EMP

C4459 C4461 C4486 C4487 C4540

 

See Note 1

See Note 2

C

 

Injections 50 mg in 1 mL single use pre‑filled syringes, 4

Injection

Enbrel

PF

EMP

C4459 C4461 C4486 C4487 C4540

 

See Note 1

See Note 2

C

 

Injection 50 mg in 1 mL single use auto‑injector, 4

Injection

Enbrel

PF

EMP

C4459 C4461 C4486 C4487 C4540

 

See Note 1

See Note 2

C

Etravirine

Tablet 200 mg

Oral

Intelence

JC

EMP

C5014

 

120

5

D

Everolimus

Tablet 0.25 mg

Oral

Certican

NV

EMP

C5554 C5555 C5794 C5795

 

120

5

C

 

Tablet 0.5 mg

Oral

Certican

NV

EMP

C5554 C5555 C5794 C5795

 

120

5

C

 

Tablet 0.75 mg

Oral

Certican

NV

EMP

C5554 C5555 C5794 C5795

 

240

5

C

 

Tablet 1 mg

Oral

Certican

NV

EMP

C5554 C5555 C5794 C5795

 

240

5

C

Filgrastim

 

Injection 120 micrograms in 0.2 mL single use pre‑filled syringe (Nivestim)

Injection

Nivestim

PF

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 300 micrograms in 0.5 mL single use pre‑filled syringe (Neupogen)

Injection

Neupogen

AN

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 300 micrograms in 0.5 mL single use pre‑filled syringe (Nivestim)

Injection

Nivestim

PF

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 300 micrograms in 0.5 mL single use pre‑filled syringe (TevaGrastim)

Injection

TevaGrastim

TB

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 300 micrograms in 0.5 mL single use pre‑filled syringe (Zarzio)

Injection

Zarzio

SZ

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 300 micrograms in 1 mL

Injection

Neupogen

AN

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 480 micrograms in 0.5 mL single use pre‑filled syringe (Neupogen)

Injection

Neupogen

AN

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 480 micrograms in 0.5 mL single use pre‑filled syringe (Nivestim)

Injection

Nivestim

PF

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 480 micrograms in 0.5 mL single use pre‑filled syringe (Zarzio)

Injection

Zarzio

SZ

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 480 micrograms in 0.8 mL single use pre‑filled syringe (TevaGrastim)

Injection

TevaGrastim

TB

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

 

Injection 480 micrograms in 1.6 mL

Injection

Neupogen

AN

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6494 C6501 C6502 C6507 C6512 C6513 C6514 C6515 C6516 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6546 C6554 C6555 C6619 C6620 C6621 C6633 C6640 C6649 C6650 C6651 C6652 C6653 C6654 C6655 C6679 C6680

 

20

11

D

Fosamprenavir

Tablet 700 mg (as calcium)

Oral

Telzir

VI

EMP

C4454 C4512

 

120

5

D

Ganciclovir

Powder for I.V. infusion 500 mg (as sodium)

Injection

Cymevene

RO

EMP

C4972 C4990 C4999 C5000 C5025

 

10

1

D

Grazoprevir with elbasvir

Tablet containing grazoprevir 100 mg with elbasvir 50 mg

Oral

Zepatier

MK

EMP

C5969 C6625

P5969

28

2

 

 

 

 

 

 

EMP

C5969 C6625

P6625

28

3

 

Ibandronic acid

Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL

Injection

Bondronat

RO

EMP

C5257 C5291

 

1

11

PB

Iloprost

Solution for inhalation 20 micrograms (as trometamol) in 2 mL

Inhalation

Ventavis

BN

EMP

C6089 C6692 C6734 C6747 C6748 C6775

 

See Note 1

See Note 2

D

Indinavir

Capsule 400 mg (as sulfate)

Oral

Crixivan 400 mg

MK

EMP

C4454 C4512

 

360

5

D

Infliximab

Powder for I.V. infusion 100 mg

Injection

Inflectra

PF

EMP

C4524 C4535 C4626 C4627 C4705 C4718 C4846 C4854 C5077 C5084 C5097 C5103 C5109 C5110 C5118 C5440 C5484 C5485 C6379 C6400 C6414 C6441 C6446 C6461 C6712 C6729 C6741 C6757 C6767 C6768 C6780 C6791 C6901 C6909 C6943 C7008 C7009 C7010 C7011 C7037 C7145

 

See Note 1

See Note 2

D

 

 

 

Remicade

JC

EMP

C4524 C4535 C4626 C4627 C4705 C4718 C4846 C4854 C5077 C5084 C5097 C5103 C5109 C5110 C5118 C5440 C5484 C5485 C6379 C6400 C6414 C6441 C6446 C6461 C6712 C6729 C6741 C6757 C6767 C6768 C6780 C6791 C6901 C6909 C6943 C7008 C7009 C7010 C7011 C7037 C7145

 

See Note 1

See Note 2

D

 

 

 

Renflexis

MK

EMP

C4524 C4535 C4626 C4627 C4705 C4718 C4846 C4854 C5077 C5084 C5097 C5103 C5109 C5110 C5118 C5440 C5484 C5485 C6379 C6400 C6414 C6441 C6446 C6461 C6712 C6729 C6741 C6757 C6767 C6768 C6780 C6791 C6901 C6909 C6943 C7008 C7009 C7010 C7011 C7037 C7145

 

See Note 1

See Note 2

D

Interferon Alfa‑2a

Injection 3,000,000 I.U. in 0.5 mL single dose pre‑filled syringe

Injection

Roferon‑A

RO

EMP

C4993 C5003 C5036 C5042

 

30

5

C

 

Injection 9,000,000 I.U. in 0.5 mL single dose pre‑filled syringe

Injection

Roferon‑A

RO

EMP

C4993 C5003 C5036 C5042

 

30

5

C

Interferon Alfa‑2b

Solution for injection 10,000,000 I.U. in 1 mL single dose vial

Injection

Intron A

MK

EMP

C4974 C4993 C5003 C5033 C5036 C5042

 

15

5

PB

 

Solution for injection 18,000,000 I.U. in 1.2 mL multi‑dose injection pen

Injection

Intron A Redipen

MK

EMP

C4974 C4993 C5003 C5033 C5036 C5042

 

2

5

C

 

Solution for injection 18,000,000 I.U. in 3 mL single dose vial

Injection

Intron A

MK

EMP

C4974 C4993 C5003 C5033 C5036 C5042

 

15

5

PB

 

Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial

Injection

Intron A

MK

EMP

C4974 C4993 C5003 C5033 C5036 C5042

 

15

5

PB

 

Solution for injection 30,000,000 I.U. in 1.2 mL multi‑dose injection pen

Injection

Intron A Redipen

MK

EMP

C4974 C4993 C5003 C5033 C5036 C5042

 

2

5

C

 

Solution for injection 60,000,000 I.U. in 1.2 mL multi‑dose injection pen

Injection

Intron A Redipen

MK

EMP

C4974 C4993 C5003 C5033 C5036 C5042

 

2

5

PB

Interferon Gamma‑1b

Injection 2,000,000 I.U. in 0.5 mL

Injection

Imukin

BY

EMP

C6222 C6286

 

12

11

D

Ivacaftor

Sachet containing granules 50 mg

Oral

Kalydeco

VR

EMP

C6857 C6861 C6862

 

56

5

D

 

Sachet containing granules 75 mg

Oral

Kalydeco

VR

EMP

C6857 C6861 C6862

 

56

5

D

 

Tablet 150 mg

Oral

Kalydeco

VR

EMP

C6861 C6862

 

56

5

D

Lamivudine

Tablet 100 mg

Oral

Zeffix

RW

EMP

C4993 C5036

 

56

5

D

 

 

 

Zetlam

AF

EMP

C4993 C5036

 

56

5

D

 

Tablet 150 mg

Oral

3TC

VI

EMP

C4454 C4512

 

120

5

D

 

 

 

 Lamivudine Alphapharm

AF

EMP

C4454 C4512

 

120

5

D

 

Tablet 300 mg

Oral

3TC

VI

EMP

C4454 C4512

 

60

5

D

 

 

 

Lamivudine Alphapharm

AF

EMP

C4454 C4512

 

60

5

D

 

Oral solution 5 mg per mL, 240 mL

Oral

Zeffix

RW

EMP

C4993 C5036

 

5

5

D

 

Oral solution 10 mg per mL, 240 mL

Oral

3TC

VI

EMP

C4454 C4512

 

8

5

D

Lamivudine with Zidovudine

Tablet 150 mg‑300 mg

Oral

Combivir

VI

EMP

C4454 C4512

 

120

5

D

 

 

 

Lamivudine 150 mg + Zidovudine 300 mg Alphapharm

AF

EMP

C4454 C4512

 

120

5

D

Lanreotide

Powder for suspension for injection 30 mg (as acetate) with diluent

Injection

Somatuline LA

IS

EMP

C7042 C7063

 

2

11

D

 

Injection 60 mg (as acetate) in single dose pre‑filled syringe

Injection

Somatuline Autogel

IS

EMP

C4569 C4575 C7025 C7041

 

2

5

D

 

Injection 90 mg (as acetate) in single dose pre‑filled syringe

Injection

Somatuline Autogel

IS

EMP

C4569 C4575 C7025 C7041

 

2

5

D

 

Injection 120 mg (as acetate) in single dose pre‑filled syringe

Injection

Somatuline Autogel

IS

EMP

C4569 C4575 C7025 C7041

 

2

5

D

Lanthanum

Tablet, chewable, 500 mg (as carbonate hydrate)

Oral

Fosrenol

ZI

EMP

C5454 C5530

 

180

5

C

 

Tablet, chewable, 750 mg (as carbonate hydrate)

Oral

Fosrenol

ZI

EMP

C5454 C5530

 

180

5

C

 

Tablet, chewable, 1000 mg (as carbonate hydrate)

Oral

Fosrenol

ZI

EMP

C5454 C5530

 

180

5

C

Ledipasvir with sofosbuvir

Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir

Oral

Harvoni

GI

EMP

C5944 C5969 C5972

P5944

28

1

 

 

 

 

 

 

EMP

C5944 C5969 C5972

P5969

28

2

 

 

 

 

 

 

EMP

C5944 C5969 C5972

P5972

28

5

 

Lenalidomide

Capsule 5 mg

Oral

Revlimid

CJ

EMP

C4282 C4287 C7380 C7381 C7383 C7404

 

See Note 1

See Note 2

D

 

Capsule 10 mg

Oral

Revlimid

CJ

EMP

C4282 C4287 C7380 C7381 C7383 C7404

 

See Note 1

See Note 2

D

 

Capsule 15 mg

Oral

Revlimid

CJ

EMP

C7380 C7381 C7383 C7404

 

See Note 1

See Note 2

D

 

Capsule 25 mg

Oral

Revlimid

CJ

EMP

C7380 C7381 C7383 C7404

 

See Note 1

See Note 2

D

Lenograstim

Powder for injection 13,400,000 I.U. (105 micrograms)

Injection

Granocyte 13

PF

EMP

C6488 C6490 C6494 C6502 C6507 C6512 C6516 C6521 C6522 C6523 C6532 C6535 C6543 C6546 C6622 C6623 C6633 C6634 C6644 C6649 C6653 C6654 C6656 C6657 C6663 C6673 C6681 C6682

 

20

11

D

 

Powder for injection 33,600,000 I.U. (263 micrograms)

Injection

Granocyte 34

PF

EMP

C6488 C6490 C6494 C6502 C6507 C6512 C6516 C6521 C6522 C6523 C6532 C6535 C6543 C6546 C6622 C6623 C6633 C6634 C6644 C6649 C6653 C6654 C6656 C6657 C6663 C6673 C6681 C6682

 

20

11

D

Levodopa with Carbidopa

Intestinal gel 20 mg‑5 mg per mL ,100 mL

Intra‑
intestinal

Duodopa

VE

EMP

C6863 C6880

 

56

5

C

Lipegfilgrastim

 

Injection 6 mg in 0.6 mL single use pre‑filled syringe

Injection

Lonquex

TB

EMP

C6488 C6489 C6490 C6491 C6492 C6493 C6501 C6507 C6512 C6513 C6514 C6515 C6521 C6522 C6523 C6531 C6532 C6533 C6534 C6535 C6536 C6543 C6544 C6545 C6554 C6555

 

1

11

D

Lopinavir with Ritonavir

Tablet 100 mg‑25 mg

Oral

Kaletra

VE

EMP

C4454 C4512

 

120

5

D

 

Tablet 200 mg‑50 mg

Oral

Kaletra

VE

EMP

C4454 C4512

 

240

5

D

 

Oral liquid 400 mg‑100 mg per 5 mL, 60 mL

Oral

Kaletra

VE

EMP

C4454 C4512

 

10

5

D

Macitentan

Tablet 10 mg

Oral

Opsumit

AT

EMP

C6089 C6693 C6722 C6734 C6735 C6748

 

30

0

D

Mannitol

Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers

Inhalation by mouth

bronchitol

XA

EMP

C7349 C7362 C7364 C7367

 

4

5

D

Maraviroc

Tablet 150 mg

Oral

Celsentri

VI

EMP

C5008

 

120

5

D

 

Tablet 300 mg

Oral

Celsentri

VI

EMP

C5008

 

120

5

D

Mepolizumab

Powder for injection 100 mg

Injection

Nucala

GK

EMP

C6635 C6646 C6665

P6635 P6646

1

5

D

 

 

 

 

 

EMP

C6635 C6646 C6665

P6665

1

7

D

Methoxy polyethylene glycol‑epoetin beta

Injection 30 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

RO

EMP

C6260 C6294

 

2

5

D

 

Injection 50 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

RO

EMP

C6260 C6294

 

2

5

D

 

Injection 75 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

RO

EMP

C6260 C6294

 

2

5

D

 

Injection 100 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

RO

EMP

C6260 C6294

 

2

5

D

 

Injection 120 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

RO

EMP

C6260 C6294

 

2

5

D

 

Injection 200 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

RO

EMP

C6260 C6294

 

2

5

D

 

Injection 360 micrograms in 0.6 mL pre‑filled syringe

Injection

Mircera

RO

EMP

C6260 C6294

 

2

5

D

Mycophenolic Acid

Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid

Oral

Myfortic

NV

EMP

C4084 C4095 C4108 C4146

 

240

5

C

 

Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid

Oral

Myfortic

NV

EMP

C4084 C4095 C4108 C4146

 

240

5

C

 

Capsule containing mycophenolate mofetil 250 mg

Oral

APO-Mycophenolate

TX

EMP

C5600 C5601 C5626 C5653

 

600

5

C

 

 

 

CellCept

RO

EMP

C5600 C5601 C5626 C5653

 

600

5

C

 

 

 

Ceptolate

AF

EMP

C5600 C5601 C5626 C5653

 

600

5

C

 

 

 

Mycophenolate Sandoz

SZ

EMP

C5600 C5601 C5626 C5653

 

600

5

C

 

 

 

Pharmacor Mycophenolate 250

CR

EMP

C5600 C5601 C5626 C5653

 

600

5

C

 

Tablet containing mycophenolate mofetil 500 mg

Oral

APO-Mycophenolate

TX

EMP

C5554 C5555 C5794 C5795