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PB 27 of 2021 Arrangements as amended, taking into account amendments up to National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (June Update) Instrument 2022
Administered by: Health
Registered 22 Jun 2022
Start Date 01 Jun 2022

Commonwealth Coat of Arms of Australia

National Health (Highly Specialised Drugs Program) Special Arrangement 2021

PB 27 of 2021

made under sections 85, 85A, 88, 99 and 100 of the

National Health Act 1953

Compilation No. 15

Compilation date:                              1 June 2022

Includes amendments up to:            F2022L00732

Registered:                                         22 June 2022

About this compilation

This compilation

This is a compilation of the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 that shows the text of the law as amended and in force on 1 June 2022 (the compilation date).

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

Uncommenced amendments

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

Application, saving and transitional provisions for provisions and amendments

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

Editorial changes

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

Modifications

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

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Part 1—Preliminary                                                                                                                                        1

Division 1—General                                                                                                                                1

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

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

5............ Simplified outline of this instrument.............................................................................. 1

6............ Definitions..................................................................................................................... 1

7............ Definition of authorised prescriber.............................................................................. 6

8............ Definition of eligible patient.......................................................................................... 8

Division 2—Supplies of HSD pharmaceutical benefits from hospitals                        10

9............ Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals.................................................................................................................................... 10

Division 3—HSD hospital authorities                                                                                           11

10.......... HSD hospital authorities............................................................................................. 11

11.......... References to approved suppliers and approved hospital authorities........................... 11

12.......... Numbers allotted to HSD hospital authorities............................................................. 11

Part 2—Special arrangement supplies of HSD pharmaceutical benefits                     12

Division 1—Preliminary                                                                                                                      12

13.......... Definition of special arrangement supply................................................................... 12

Division 2—Prescribing of HSD pharmaceutical benefits                                                 14

14.......... Prescribing of HSD pharmaceutical benefits—authorised prescribers (Act s 88(1) and (1E)) 14

15.......... Prescription circumstances—general (Act s 85(7)(a) and (b))..................................... 14

16.......... Prescription circumstances—authority required procedures........................................ 15

17.......... Prescription circumstances—modifications during COVID‑19 pandemic (Act s 85(7)(a) and (b))         15

18.......... When medication chart prescriptions not to be written................................................ 16

19.......... Prescriptions not to direct repeated supplies for visitors to Australia.......................... 16

20.......... Maximum quantity or number of units (Act s 85A(2)(a))........................................... 16

21.......... Maximum number of repeats (Act s 85A(2)(b))......................................................... 17

22.......... No variation of application of determination of maximum number of repeats or maximum number or quantity of units—HSD pharmaceutical benefits that have CAR drugs.................................................... 18

23.......... Records to be kept—prescriptions for HSD pharmaceutical benefits that contain eculizumab for the treatment of atypical haemolytic uraemic syndrome..................................................................................... 18

Division 3—Supplying HSD pharmaceutical benefits                                                          19

24.......... Special patient contribution for certain HSD pharmaceutical benefits.......................... 19

25.......... Modified application of conditions of approval of approved pharmacists................... 19

26.......... Supplies by HSD hospital authorities need not be directly to persons......................... 19

27.......... Repeated supplies of pharmaceutical benefits.............................................................. 20

Part 3—Payment for special arrangement supplies of HSD pharmaceutical benefits    21

Division 1—Supplies by approved hospital authorities for public hospitals            21

28.......... Rates of payment for approved hospital authorities for public hospitals (Act s 99(4)) 21

29.......... Dispensed price for approved hospital authorities for public hospitals........................ 21

Division 2—Supplies by other approved suppliers                                                                23

30.......... Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners   23

31.......... Rates of payment for approved hospital authorities for private hospitals (Act s 99(4)) 23

32.......... Dispensed price for approved suppliers other than approved hospital authorities for public hospitals     23

33.......... Mark‑up for ready‑prepared pharmaceutical benefits.................................................. 24

34.......... Dispensing fee............................................................................................................. 25

Part 4—Claims for payment for special arrangement supplies of HSD pharmaceutical benefits           26

35.......... Rules for providing information about supplies—definition of under co‑payment data 26

Part 5—Miscellaneous                                                                                                                                 27

36.......... Compliance and audit arrangements............................................................................ 27

37.......... Value for safety net purposes for supplies................................................................... 27

Part 6—Application, saving and transitional provisions                                                        28

Division 1—Provisions relating to this instrument as made                                             28

38.......... HSD hospital authorities............................................................................................. 28

Schedule 1—HSD pharmaceutical benefits and related information 29

1............ Highly specialised drugs and HSD pharmaceutical benefits........................................ 29

Schedule 2—Maximum quantities and repeats for certain HSD pharmaceutical benefits                                                                                                                            139

1............ Maximum quantity or number of units and maximum number of repeats................. 139

Schedule 3—Circumstances and purposes                                                                144

1............ Circumstances and purposes..................................................................................... 144

Schedule 4—HSD pharmaceutical benefits with modified prescription circumstances during COVID‑19 pandemic                                                                   584

1............ HSD pharmaceutical benefits with modified prescription circumstances during COVID‑19 pandemic   584

Endnotes                                                                                                                                                             587

Endnote 1—About the endnotes                                                                                                    587

Endnote 2—Abbreviation key                                                                                                        588

Endnote 3—Legislation history                                                                                                     589

Endnote 4—Amendment history                                                                                                   592


Part 1Preliminary

Division 1General

1  Name

             (1)  This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement 2021.

             (2)  This instrument may also be cited as PB 27 of 2021.

3  Authority

                   This instrument is made under sections 85, 85A, 88, 99 and 100 of the National Health Act 1953.

5  Simplified outline of this instrument

This instrument makes a special arrangement for the supply of pharmaceutical benefits that contain highly specialised drugs for the treatment of chronic conditions.

Restrictions apply to the prescribing and supply of these benefits because of their clinical use and other special features.

The prescribing of these benefits is in most cases limited to practitioners who have undertaken particular training or are affiliated with a specialised hospital unit.

The supply of these benefits is restricted to persons who are receiving treatment by medical practitioners and authorised nurse practitioners.

These benefits will be supplied by approved suppliers (public and private hospitals, community pharmacies and certain medical practitioners).

This instrument also deals with payments for supplies of these pharmaceutical benefits.

Note:          Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).

6  Definitions

Note 1:       A number of expressions used in this instrument are defined in the Act, including the following:

(a)    Chief Executive Medicare;

(b)    hospital;

(c)    public hospital.

Note 2:       Under subsection 4(1A) of the Act, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that are defined in that Act include the following:

(a)    eligible person;

(b)    medical practitioner;

(c)    private hospital;

(d)    specialist.

                   In this instrument:

accredited prescriber of medication for the treatment of hepatitis B means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis B in accordance with this instrument.

accredited prescriber of medication for the treatment of hepatitis C means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis C in accordance with this instrument.

accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS in accordance with this instrument.

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 in accordance with this instrument.

Act means the National Health Act 1953.

affiliated: a specialist is affiliated with a hospital if the specialist is:

                     (a)  a staff specialist of the hospital; or

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

approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

approved hospital authority has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.

approved medical practitioner has the same meaning as in Part VII of the Act.

approved pharmacist has the same meaning as in Part VII of the Act.

approved supplier has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.

authorised nurse practitioner has the same meaning as in Part VII of the Act.

authorised prescriber has the meaning given by section 7.

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

                     (a)  abatacept;

                     (b)  adalimumab;

                     (c)  ambrisentan;

                     (d)  azacitidine;

                     (e)  benralizumab;

                      (f)  bosentan;

                     (g)  dupilumab;

                     (h)  eculizumab;

                      (i)  elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;

                      (j)  eltrombopag;

                     (k)  epoprostenol;

                      (l)  etanercept;

                    (m)  iloprost;

                     (n)  infliximab;

                     (o)  ivacaftor;

                     (p)  lenalidomide;

                     (q)  lumacaftor with ivacaftor;

                      (r)  macitentan;

                      (s)  mepolizumab;

                      (t)  midostaurin;

                     (u)  nusinersen;

                     (v)  omalizumab;

                    (w)  onasemnogene abeparvovec;

                     (x)  pasireotide;

                     (y)  pegvisomant;

                     (z)  pomalidomide;

                    (aa)  ravulizumab

                   (bb)  riociguat;

                    (cc)  risdiplam

                   (dd)  rituximab;

                    (ee)  romiplostim;

                    (ff)  sildenafil;

                    (gg)  tadalafil;

                   (hh)  teduglutide;

                     (ii)  tezacaftor with ivacaftor and ivacaftor;

                     (jj)  tocilizumab;

                   (kk)  ustekinumab;

                     (ll)  vedolizumab.

circumstances code means the letter “C” followed by a number.

community access medication means any of the following:

                     (a)  medication for the treatment of hepatitis B;

                     (b)  medication for the treatment of HIV or AIDS, other than a pharmaceutical benefit that has the drug:

                              (i)  azithromycin; or

                             (ii)  doxorubicin ‑ pegylated liposomal; or

                            (iii)  rifabutin;

                     (c)  medication for continuing treatment of schizophrenia;

                     (d)  lanreotide, if:

                              (i)  the description of its form does not include “Powder for suspension for injection”; and

                             (ii)  it is for continuing treatment;

                     (e)  octreotide, if:

                              (i)  the description of its form includes “Injection (modified release)”; and

                             (ii)  it is for continuing treatment.

day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:

                     (a)  is admitted to the hospital (other than through the hospital’s emergency department); and

                     (b)  receives treatment; and

                     (c)  is discharged from the hospital;

in accordance with a pre‑existing plan for the person’s treatment.

dispensed price:

                     (a)  for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 29; and

                     (b)  for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital—has the meaning given by section 32.

eligible patient has the meaning given by section 8.

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

hospital authority has the same meaning as in Part VII of the Act.

HSD hospital authority means a hospital authority for which:

                     (a)  an approval under section 94 of the Act, as modified by section 10 of this instrument, is in force; or

                     (b)  an approval mentioned in section 38 of this instrument is in force.

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

listed drug has the same meaning as in Part VII of the Act.

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

medication chart prescription has the same meaning as in the Regulations.

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

                     (a)  adefovir;

                     (b)  entecavir;

                     (c)  lamivudine;

                     (d)  tenofovir.

medication for the treatment of hepatitis C means medication mentioned in the table in paragraph 3 of the General Statement for drugs for the treatment of hepatitis C set out in Part 3 of Schedule 4 to the Listing Instrument.

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;

                     (e)  atazanavir with cobicistat;

                      (f)  azithromycin;

                     (g)  bictegravir with emtricitabine with tenofovir alafenamide;

                     (h)  cabotegravir;

                      (i)  cabotegravir and rilpivirine;

                      (j)  darunavir;

                     (k)  darunavir with cobicistat;

                      (l)  darunavir with cobicistat, emtricitabine and tenofovir alafenamide;

                    (m)  dolutegravir;

                     (n)  dolutegravir with abacavir and lamivudine;

                     (o)  dolutegravir with lamivudine;

                     (p)  dolutegravir with rilpivirine;

                     (q)  doxorubicin ‑ pegylated liposomal;

                      (r)  efavirenz;

                      (s)  emtricitabine with rilpivirine with tenofovir alafenamide;

                      (t)  emtricitabine with tenofovir alafenamide;

                     (u)  enfuvirtide;

                     (v)  etravirine;

                    (w)  fosamprenavir;

                     (x)  ganciclovir;

                     (y)  lamivudine;

                     (z)  lamivudine with zidovudine;

                    (aa)  lopinavir with ritonavir;

                   (bb)  maraviroc;

                    (cc)  nevirapine;

                   (dd)  raltegravir;

                    (ee)  rifabutin;

                    (ff)  rilpivirine;

                    (gg)  ritonavir;

                   (hh)  saquinavir;

                     (ii)  tenofovir;

                     (jj)  tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;

                   (kk)  tenofovir with emtricitabine;

                     (ll)  tenofovir with emtricitabine and efavirenz;

                 (mm)  tipranavir;

                   (nn)  valganciclovir;

                   (oo)  zidovudine.

medication for the treatment of schizophrenia means clozapine.

non‑CAR drug means a highly specialised drug that is not a CAR drug.

pack quantity has the same meaning as in Part VII of the Act.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

pharmaceutical item has the same meaning as in Part VII of the Act.

proportional ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.

purposes code means the letter “P” followed by a number.

Regulations means the National Health (Pharmaceutical Benefit) Regulations 2017.

residential care service has the same meaning as in the Regulations.

shelf life, of a medicine, means the period of time that the medicine can be stored and still be considered safe and effective for use.

special arrangement supply has the meaning given by section 13.

7  Definition of authorised prescriber

Specialists affiliated with hospitals

             (1)  A specialist is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if the specialist is affiliated with the hospital.

Medical practitioners—with the agreement of specialists

             (2)  A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient receiving treatment in, at or from a hospital if all of the following apply:

                     (a)  the benefit is for continuing treatment for the patient;

                     (b)  the patient’s treatment is being managed by a specialist;

                     (c)  it is impractical for the patient to obtain a prescription for the benefit from the specialist;

                     (d)  the specialist has agreed to the prescribing of the benefit for the patient by the medical practitioner.

Medical practitioners—if authorised by Commonwealth and State authorities

             (3)  A medical practitioner is an authorised prescriber for an HSD pharmaceutical benefit for a patient if all of the following apply:

                     (a)  the HSD pharmaceutical benefit is for continuing treatment for the patient;

                     (b)  the medical practitioner is authorised (however described) by an authority of the Commonwealth for the purposes of this provision;

                     (c)  the medical practitioner is authorised (however described) by an authority of the State or Territory in which the hospital is located for the purposes of this provision.

Medical practitioners—medication for the treatment of hepatitis C, lanreotide and octreotide

             (4)  A medical practitioner is an authorised prescriber for the following HSD pharmaceutical benefits:

                     (a)  a medication for the treatment of hepatitis C;

                     (b)  lanreotide, if:

                              (i)  the description of its form does not include “Powder for suspension for injection”; and

                             (ii)  it is for continuing treatment;

                     (c)  octreotide, if:

                              (i)  the description of its form includes “Injection (modified release)”; and

                             (ii)  it is for continuing treatment.

Accredited prescribers—for HSD pharmaceutical benefits for the treatment of hepatitis B, hepatitis C, HIV or AIDS, and schizophrenia

             (5)  A person mentioned in column 1 of an item of the following table is an authorised prescriber for an HSD pharmaceutical benefit mentioned in column 2 of the item.

 

Authorised prescribers for certain HSD pharmaceutical benefits

Item

Column 1
Person

Column 2
HSD pharmaceutical benefit

1

An accredited prescriber of medication for the treatment of hepatitis B

A medication for the treatment of hepatitis B

2

An accredited prescriber of medication for the treatment of hepatitis C

A medication for the treatment of hepatitis C

3

An accredited prescriber of medication for the treatment of HIV or AIDS

A medication for the treatment of HIV or AIDS

4

An accredited prescriber of medication for the treatment of schizophrenia

A medication for the treatment of schizophrenia

8  Definition of eligible patient

Persons receiving treatment by medical practitioners at or from public hospitals other than as admitted patients

             (1)  A person is an eligible patient for an HSD pharmaceutical benefit if the person:

                     (a)  is, or is to be treated as, an eligible person; and

                     (b)  is receiving medical treatment by a medical practitioner at or from a public hospital; and

                     (c)  is receiving that treatment as:

                              (i)  a non‑admitted patient of the hospital; or

                             (ii)  a day admitted patient of the hospital; or

                            (iii)  a patient on discharge from the hospital.

Persons receiving treatment by authorised nurse practitioners at or from public hospitals other than as admitted patients—medication for the treatment of hepatitis C

             (2)  A person is an eligible patient for an HSD pharmaceutical benefit that is a medication for the treatment of hepatitis C if the person:

                     (a)  is, or is to be treated as, an eligible person; and

                     (b)  is receiving medical treatment by an authorised nurse practitioner at or from a public hospital; and

                     (c)  is receiving that treatment as:

                              (i)  a non‑admitted patient of the hospital; or

                             (ii)  a day admitted patient of the hospital; or

                            (iii)  a patient on discharge from the hospital.

Persons receiving treatment by medical practitioners in public hospitals as admitted patients—HSD pharmaceutical benefits that contain eculizumab for the treatment of atypical haemolytic uraemic syndrome

             (3)  A person is an eligible patient for an HSD pharmaceutical benefit that contains eculizumab for the treatment of atypical haemolytic uraemic syndrome if the person:

                     (a)  is, or is to be treated as, an eligible person; and

                     (b)  is receiving medical treatment by a medical practitioner in a public hospital; and

                     (c)  is receiving that treatment as an admitted patient (other than a day admitted patient) of the hospital.

Persons receiving treatment by medical practitioners in, at or from private hospitals

             (4)  A person is an eligible patient for an HSD pharmaceutical benefit if the person:

                     (a)  is, or is to be treated as, an eligible person; and

                     (b)  is receiving medical treatment by a medical practitioner in, at or from a private hospital.

Persons receiving treatment by authorised nurse practitioners in, at or from private hospitals—medication for the treatment of hepatitis C

             (5)  A person is an eligible patient for an HSD pharmaceutical benefit that is a medication for the treatment of hepatitis C if the person:

                     (a)  is, or is to be treated as, an eligible person; and

                     (b)  is receiving medical treatment by an authorised nurse practitioner in, at or from a private hospital.

Persons receiving HSD pharmaceutical benefits that are community access medications

             (6)  A person is an eligible patient for an HSD pharmaceutical benefit if:

                     (a)  the benefit is a community access medication; and

                     (b)  the person is, or is to be treated as, an eligible person.

Division 2Supplies of HSD pharmaceutical benefits from hospitals

9  Supplies of HSD pharmaceutical benefits by approved hospital authorities to patients receiving treatment from hospitals

             (1)  In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved hospital authority supplying pharmaceutical benefits to patients receiving treatment in or at the hospital of which it is the governing body or proprietor includes a reference to the hospital authority supplying HSD pharmaceutical benefits to patients receiving treatment from the hospital.

             (2)  This section applies in addition to section 94 of the Act.

Division 3HSD hospital authorities

10  HSD hospital authorities

             (1)  Section 94 of the Act applies as if that section permitted the Minister to approve a hospital authority for the purpose of its supplying HSD pharmaceutical benefits to patients receiving treatment in, at or from the hospital of which it is the governing body or proprietor if the dispensing of those benefits is performed:

                     (a)  other than at the hospital; and

                     (b)  by or under the direct supervision of a medical practitioner or pharmacist.

             (2)  Subsection (1) applies despite subsection 94(5) of the Act.

11  References to approved suppliers and approved hospital authorities

                   In this instrument, and in Part VII of the Act and regulations or other instruments made for the purposes of that Part, a reference to an approved supplier or an approved hospital authority includes a reference to an HSD hospital authority.

12  Numbers allotted to HSD hospital authorities

                   For the purposes of Part VII of the Act and regulations or other instruments made for the purposes of that Part, a number allotted to an HSD hospital authority under either of the following provisions is taken to have been allotted by the Minister under subsection 16(4) of the Regulations:

                     (a)  subsection 52(3) of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010);

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

Part 2Special arrangement supplies of HSD pharmaceutical benefits

Division 1Preliminary

13  Definition of special arrangement supply

Prescriptions written for public hospital patients

             (1)  A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

                     (a)  the person is an eligible patient for the benefit; and

                     (b)  the benefit is supplied by:

                              (i)  for any benefit—an approved hospital authority for a public hospital; or

                             (ii)  for a benefit that has a CAR drug—an approved pharmacist; and

                     (c)  the benefit is supplied on the basis of a prescription written:

                              (i)  when the person was receiving medical treatment in, at or from a public hospital; and

                             (ii)  by an authorised prescriber for the benefit; and

                            (iii)  in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Prescriptions written for private hospital patients

             (2)  A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

                     (a)  the person is an eligible patient for the benefit; and

                     (b)  the benefit is supplied by:

                              (i)  an approved hospital authority for a private hospital; or

                             (ii)  an approved pharmacist; and

                     (c)  the benefit is supplied on the basis of a prescription written:

                              (i)  when the person was receiving medical treatment in, at or from a private hospital; and

                             (ii)  by an authorised prescriber for the benefit; and

                            (iii)  in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Community access arrangements

             (3)  A supply of an HSD pharmaceutical benefit to a person is a special arrangement supply of the benefit if:

                     (a)  the benefit is a community access medication; and

                     (b)  the person is an eligible patient for the benefit; and

                     (c)  the benefit is supplied by an approved supplier; and

                     (d)  the benefit is supplied on the basis of a prescription written:

                              (i)  by an authorised prescriber for the benefit; and

                             (ii)  in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 for the benefit.

Division 2Prescribing of HSD pharmaceutical benefits

14  Prescribing of HSD pharmaceutical benefits—authorised prescribers (Act s 88(1) and (1E))

Medical practitioners

             (1)  For the purposes of subsection 88(1) of the Act applying to a medical practitioner who is an authorised prescriber for an HSD pharmaceutical benefit, the benefit is determined.

             (2)  Subsection 9(1A) of the Listing Instrument (which provides for the pharmaceutical benefits for which medical practitioners are authorised to write prescriptions) does not apply to an HSD pharmaceutical benefit other than a medication for the treatment of hepatitis C.

Authorised nurse practitioners

             (3)  For the purposes of subsection 88(1E) of the Act applying to an authorised nurse practitioner who is an authorised prescriber for an HSD pharmaceutical benefit, the benefit is determined.

“Supply only” pharmaceutical benefits

             (4)  Subsections (1) and (3) do not apply to an HSD pharmaceutical benefit mentioned in Part 2 of Schedule 1 to the Listing Instrument (ready‑prepared pharmaceutical benefits for supply only).

15  Prescription circumstances—general (Act s 85(7)(a) and (b))

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

             (2)  For the purposes of paragraph 85(7)(b) of the Act, the circumstances in which a prescription for a special arrangement supply of an HSD pharmaceutical benefit may be written are the circumstances mentioned in Schedule 3 to this instrument for a circumstances code mentioned in the column headed “Circumstances” in Schedule 1 to this instrument for the benefit.

             (3)  This section applies in addition to section 10 of the Listing Instrument.

             (4)  This section has effect subject to section 17 (which temporarily modifies the circumstances mentioned in Schedule 3 for circumstances codes for HSD pharmaceutical benefits that are pharmaceutical items described in Schedule 4).

16  Prescription circumstances—authority required procedures

             (1)  This section applies to a prescription for a special arrangement supply of an HSD pharmaceutical benefit if the circumstances mentioned in Schedule 3 in which the prescription is written include:

                     (a)  Compliance with Authority Required procedures; or

                     (b)  Compliance with Written Authority Required procedures.

             (2)  Sections 11 to 14 of the Listing Instrument apply to the prescription as if:

                     (a)  a reference in those provisions to “Part 1 of Schedule 4” or “Schedule 4” were a reference to Schedule 3 to this instrument; and

                     (b)  a reference in those provisions to an “authorised prescriber” were a reference to an authorised prescriber within the meaning of this instrument.

17  Prescription circumstances—modifications during COVID‑19 pandemic (Act s 85(7)(a) and (b))

             (1)  This section affects the circumstances in which a prescription may be written by an authorised prescriber for the supply of an HSD pharmaceutical benefit that is a listed brand of a pharmaceutical item described in Schedule 4 to a person (the patient) if the authorised prescriber is satisfied the patient has, in accordance with this instrument, already been supplied with the benefit on the basis of a prescription:

                     (a)  written, on or after 1 April 2021, in circumstances determined by subsection 10(1) of the Listing Instrument unaffected by this section; or

                     (b)  written, before 1 April 2021, in circumstances determined by subsection 9(1) of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) unaffected by section 9AA of that instrument.

             (2)  For the purposes of subsection 10(1) of the Listing Instrument and subsection 15(2) of this instrument, Part 1 of Schedule 4 to the Listing Instrument and Schedule 3 to this instrument have effect as if each circumstances code for the HSD pharmaceutical benefit:

                     (a)  did not mention any circumstance that, having regard to the patient’s situation and the state of affairs associated with precautions against the spread of the coronavirus known as COVID‑19, it is not reasonably practicable to establish in relation to the patient; and

                     (b)  mentioned the circumstance that the authorised prescriber keeps a written record of the reason it is not practicable to establish the circumstance described in paragraph (a).

             (3)  This section, subsection 15(4) and Schedule 4 to this instrument are repealed at the start of 1 July 2022.

18  When medication chart prescriptions not to be written

HSD pharmaceutical benefits that have CAR drugs

             (1)  Subparagraph 39(a)(ii) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug.

Persons receiving treatment in residential care services

             (2)  Subparagraph 41(1)(a)(i) of the Regulations does not apply to a prescription for a special arrangement supply of an HSD pharmaceutical benefit.

19  Prescriptions not to direct repeated supplies for visitors to Australia

             (1)  An authorised prescriber for an HSD pharmaceutical benefit must not write a prescription directing a repeated supply of an HSD pharmaceutical benefit to 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.

             (2)  This section applies despite section 85A of the Act.

20  Maximum quantity or number of units (Act s 85A(2)(a))

             (1)  For the purposes of paragraph 85A(2)(a) of the Act, this section sets out the maximum quantity or number of units of the pharmaceutical item in an HSD pharmaceutical benefit that may, in one prescription for a special arrangement supply of the benefit, be directed by an authorised prescriber to be supplied on any one occasion.

Supply for particular purposes

             (2)  If:

                     (a)  a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

                     (b)  the supply of the benefit is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum quantity or number of units is the quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

             (3)  If:

                     (a)  a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

                     (b)  a quantity or number of units is mentioned in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit;

the maximum quantity or number of units is that quantity or number of units.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

             (4)  If:

                     (a)  a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

                     (b)  the words “See Schedule 2” appear in the column headed “Maximum quantity” in Schedule 1 to this instrument for the benefit; and

                     (c)  the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum quantity or number of units is the quantity or number of units that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

             (5)  To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

             (6)  To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

21  Maximum number of repeats (Act s 85A(2)(b))

             (1)  For the purposes of paragraph 85A(2)(b) of the Act, this section sets out the maximum number of occasions an authorised prescriber may, in one prescription, direct that a special arrangement supply of an HSD pharmaceutical benefit be repeated.

Supply for particular purposes

             (2)  If:

                     (a)  a purposes code is mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

                     (b)  the supply is for purposes mentioned in Schedule 3 to this instrument for the purposes code;

the maximum number is the number mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit and the purposes code.

Supply for all purposes—HSD pharmaceutical benefits not in Schedule 2

             (3)  If:

                     (a)  a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

                     (b)  a number is mentioned in the column headed “Maximum repeats” in Schedule 1 to this instrument for the benefit;

the maximum number is that number.

Supply for all purposes—HSD pharmaceutical benefits in Schedule 2

             (4)  If:

                     (a)  a purposes code is not mentioned in the column headed “Purposes” in Schedule 1 to this instrument for the benefit; and

                     (b)  the words “See Schedule 2” appear in the column headed “Maximum repeats” in Schedule 1 for the benefit; and

                     (c)  the prescription is written in circumstances mentioned in Schedule 3 for a circumstances code mentioned in the column headed “Circumstances” in Schedule 2 to this instrument for the benefit;

the maximum number is the number that is applicable under Schedule 2 to this instrument for the benefit and the circumstances code.

             (5)  To the extent that this section provides for a matter not provided for in the Listing Instrument, this section applies in addition to the Listing Instrument.

             (6)  To the extent that this section makes a different provision for a matter provided for in the Listing Instrument, this section applies despite the Listing Instrument.

22  No variation of application of determination of maximum number of repeats or maximum number or quantity of units—HSD pharmaceutical benefits that have CAR drugs

                   Section 30 of the Regulations does not apply in relation to a practitioner (within the meaning of section 29 of the Regulations) who has written a prescription for a special arrangement supply of an HSD pharmaceutical benefit that has a CAR drug.

Note:          Section 30 of the Regulations allows the Minister to vary the application of a determination under paragraph 85A(2)(a) or (b) of the Act in certain circumstances.

23  Records to be kept—prescriptions for HSD pharmaceutical benefits that contain eculizumab for the treatment of atypical haemolytic uraemic syndrome

             (1)  If an authorised prescriber for an HSD pharmaceutical benefit that contains eculizumab for the treatment of atypical haemolytic uraemic syndrome writes a prescription for a special arrangement supply of the benefit, a copy of any clinical records relating to the prescription, including records required to demonstrate that the prescription was written in compliance with the circumstances and purposes determined in relation to the benefit under subsection 85(7) of the Act, must be kept by:

                     (a)  the approved hospital authority for the hospital in, at or from which the eligible patient is receiving treatment; or

                     (b)  if the approved hospital authority is not able to keep the records—the authorised prescriber.

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

Division 3Supplying HSD pharmaceutical benefits

24  Special patient contribution for certain HSD pharmaceutical benefits

             (1)  This section applies to a special arrangement supply of an HSD pharmaceutical benefit mentioned in the following table.

 

Special patient contribution for certain HSD pharmaceutical benefits

Item

Drug

Form

Manner of administration

Brand

Pack quantity

Claimed price ($)

1

Lamivudine

Tablet 100 mg

Oral

Zeffix

28

35.30

2

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

Valtrex

100

44.64

             (2)  The special patient contribution for a pack quantity of a listed brand of a pharmaceutical item mentioned in the table is the amount that is the difference between:

                     (a)  the price that would have been the dispensed price for that quantity of the brand of the pharmaceutical item if that dispensed price had been based on the claimed price (within the meaning of Part VII of the Act) mentioned in the table for that quantity; and

                     (b)  the dispensed price for that quantity of the brand of the pharmaceutical item.

             (3)  This section applies despite subsection 85B(5) of the Act.

25  Modified application of conditions of approval of approved pharmacists

                   Section 8 of the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2017 (PB 70 of 2017) does not apply to a special arrangement supply of an HSD pharmaceutical benefit, once prepared as a final product ready for infusion to a person, if the benefit has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.

26  Supplies by HSD hospital authorities need not be directly to persons

             (1)  An HSD hospital authority may make a special arrangement supply of an HSD pharmaceutical benefit to a person:

                     (a)  other than directly to the person; or

                     (b)  through an agent.

             (2)  This section applies in addition to section 94 of the Act.

27  Repeated supplies of pharmaceutical benefits

                   Section 51 of the Regulations does not apply to a special arrangement supply of HSD pharmaceutical benefits.

Part 3Payment for special arrangement supplies of HSD pharmaceutical benefits

Division 1Supplies by approved hospital authorities for public hospitals

28  Rates of payment for approved hospital authorities for public hospitals (Act s 99(4))

             (1)  For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a public hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the hospital authority was entitled to charge under section 87 of the Act in respect of the supply.

             (2)  This section applies despite the National Health (Commonwealth Price—Pharmaceutical Benefits Supplied By Public Hospitals) Determination 2017 (PB 25 of 2017).

Note:          See subsection 99(4) of the Act (read with section 9 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

29  Dispensed price for approved hospital authorities for public hospitals

             (1)  The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital is as follows:

                     (a)  if the quantity of the benefit 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 (as applicable) for each pack quantity;

                     (b)  if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the amount worked out in accordance with subsection (2);

                     (c)  if the quantity of the benefit 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 (as applicable) for each pack quantity; and

                             (ii)  the amount calculated in accordance with subsection (2) for the remainder of the quantity that is a broken quantity.

Broken quantities

             (2)  For the purposes of paragraph (1)(b) and subparagraph (1)(c)(ii), the amount for a broken quantity is worked out 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 (as applicable) for the pack quantity.

Rounding

             (3)  The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

Division 2Supplies by other approved suppliers

30  Entitlement to, and amount of, payment for approved pharmacists and approved medical practitioners

             (1)  This section applies if:

                     (a)  an approved pharmacist or approved medical practitioner has supplied an HSD pharmaceutical benefit; and

                     (b)  the supply is a special arrangement supply of the benefit.

             (2)  The approved pharmacist or approved medical practitioner is, subject to section 99AAA of the Act and the conditions determined under section 98C of the Act that are applicable at the time of the supply, entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the approved pharmacist or approved medical practitioner was entitled to charge under section 87 of the Act in respect of the supply.

             (3)  This section applies despite subsections 99(2) and (2AA) of the Act.

31  Rates of payment for approved hospital authorities for private hospitals (Act s 99(4))

             (1)  For the purposes of subsection 99(4) of the Act, the amount payable to an approved hospital authority for a private hospital in respect of a special arrangement supply of an HSD pharmaceutical benefit by the authority is the amount, if any, by which the dispensed price for the supply of the benefit exceeds the amount that the authority was entitled to charge under section 87 of the Act in respect of the supply.

             (2)  This section applies despite the National Health (Commonwealth Price ‑ Pharmaceutical benefits supplied by private hospitals) Determination 2020 (PB 99 of 2020).

Note:          See subsection 99(4) of the Act (read with section 9 of this instrument) for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in, at or from a hospital in respect of which the authority is approved.

32  Dispensed price for approved suppliers other than approved hospital authorities for public hospitals

             (1)  The dispensed price for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital is as follows:

                     (a)  if the quantity of the benefit supplied is equal to a multiple of a pack quantity of the benefit—the sum of:

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

                             (ii)  if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

                            (iii)  the dispensing fee for the benefit in accordance with section 34;

                     (b)  if the quantity of the benefit supplied is less than a pack quantity of the benefit (a broken quantity)—the sum of:

                              (i)  the amount worked out in accordance with subsection (2); and

                             (ii)  the dispensing fee for the benefit in accordance with section 34;

                     (c)  if the quantity of the benefit 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 (as applicable) for each pack quantity; and

                             (ii)  if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for each pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards); and

                            (iii)  the amount worked out in accordance with subsection (2) for the remainder of the quantity that is a broken quantity; and

                            (iv)  the dispensing fee for the benefit in accordance with section 34.

Broken quantities

             (2)  For the purposes of subparagraphs (1)(b)(i) and (c)(iii), the amount for a broken quantity is worked out 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 sum of:

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

                             (ii)  if the benefit is a ready‑prepared pharmaceutical benefit—the mark‑up mentioned in section 33 for the pack quantity, rounded to the nearest cent (rounding 0.5 cents upwards).

Rounding

             (3)  The dispensed price under subsection (1) is rounded to the nearest cent (rounding 0.5 cents upwards).

33  Mark‑up for ready‑prepared pharmaceutical benefits

                   For the purposes of subparagraphs 32(1)(a)(ii), (c)(ii) and (2)(b)(ii), the mark‑up for a pack quantity of an HSD pharmaceutical benefit that is a ready‑prepared pharmaceutical benefit is:

                     (a)  if the pack quantity of the benefit is equal to the maximum quantity of the benefit mentioned in section 20—the amount mentioned in the following table for the approved ex‑manufacturer price (AEMP) or proportional ex‑manufacturer price (PEMP) (as applicable) for that quantity; or

                     (b)  if the pack quantity of the benefit is less than the maximum quantity of the benefit mentioned in section 20:

                              (i)  if the mark‑up mentioned in the following table for the maximum quantity is a monetary amount—that monetary amount reduced proportionately for the relative quantities; or

                             (ii)  if the mark‑up mentioned in the following table for the maximum quantity is a percentage of the AEMP or PEMP (as applicable)—that percentage of the AEMP or PEMP for the pack quantity.

 

Mark‑up for ready‑prepared pharmaceutical benefits

Item

If the AEMP or PEMP (as applicable) for the maximum quantity is …

the mark‑up for the maximum quantity is …

1

less than $40

10% of the AEMP or PEMP

2

at least $40 but not more than $100

$4

3

more than $100 but not more than $1,000

4% of the AEMP or PEMP

4

more than $1,000

$40

34  Dispensing fee

             (1)  For the purposes of subparagraphs 32(1)(a)(iii), (b)(ii) and (c)(iv):

                     (a)  the dispensing fee for the supply of an HSD pharmaceutical benefit is:

                              (i)  if the benefit has a drug mentioned in subsection (2) in the form mentioned in that subsection for the drug—the extemporaneously‑prepared dispensing fee (within the meaning of the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020 (PB 66 of 2020)); or

                             (ii)  if subparagraph (i) does not apply—the ready‑prepared dispensing fee (within the meaning of that determination); and

                     (b)  if the authorised prescriber who prescribed the benefit, instead of directing a repeated supply of the benefit, directed the supply on one occasion of a quantity or number of units of the benefit, not exceeding the total quantity or number of units that could be prescribed if the authorised prescriber directed a repeated supply, only one dispensing fee is included in the dispensed price for the supply of the benefit.

Note:          See section 49 of the Regulations for the circumstances in which such a supply may be directed.

             (2)  For the purpose of subparagraph (1)(a)(i), 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;

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

Part 4Claims for payment for special arrangement supplies of HSD pharmaceutical benefits

  

35  Rules for providing information about supplies—definition of under co‑payment data

                   The National Health (Claims and under co‑payment data) Rules 2012 (PB 19 of 2012) apply to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier as if the definition of under co‑payment data in that instrument were replaced with the following definition:

under co‑payment data means information relating to a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier where the amount payable by the Commonwealth is nil because the dispensed price for the supply of the benefit does not exceed the amount that the supplier was entitled to charge under section 87 of the Act in respect of the supply.

Part 5Miscellaneous

  

36  Compliance and audit arrangements

             (1)  If an approved supplier makes a special arrangement supply of an HSD pharmaceutical benefit, the approved supplier 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.

37  Value for safety net purposes for supplies

Supplies by approved hospital authorities

             (1)  The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved hospital authority is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under subsection 87(5) of the Act for the supply of the benefit less the amount chargeable under that subsection because of subsection 87(2A) of the Act.

Supplies by approved pharmacists and approved medical practitioners

             (2)  The value for safety net purposes for a special arrangement supply of an HSD pharmaceutical benefit to a person by an approved pharmacist or approved medical practitioner is the amount paid by the person for the supply of the benefit that is equivalent to the amount chargeable under section 87 of the Act for the supply of the benefit less the amount chargeable under subsection 87(2A) of the Act.

             (3)  This section applies despite regulation 17A of the Regulations.

Part 6Application, saving and transitional provisions

Division 1Provisions relating to this instrument as made

38  HSD hospital authorities

                   Despite the repeal of the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010):

                     (a)  an approval that was in force under subsection 52(2) of that instrument immediately before 1 April 2021; and

                     (b)  an approval that was continued in force under section 53 of that instrument as if it were an approval under subsection 52(2) of that instrument, and was in force immediately before 1 April 2021;

continues in force as if it were an approval under section 94 of the Act, as modified by section 10 of this instrument.


Schedule 1HSD pharmaceutical benefits and related information

  

  

Note:       See the definitions of highly specialised drug and HSD pharmaceutical benefit in section 6, and sections 13, 15, 20 and 21.

1  Highly specialised drugs and HSD pharmaceutical benefits

             (1)  Each listed drug specified in the following table is a highly specialised drug.

             (2)  Each pharmaceutical benefit specified in the following table is an HSD pharmaceutical benefit.

             (3)  The following table also specifies circumstances, purposes, maximum quantities and maximum repeats for HSD pharmaceutical benefits.

Note:          The drugs mentioned in the table have been declared by the Minister under subsection 85(2) of the Act. The forms, manners of administration and brands mentioned in the table have been determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively.

 

HSD pharmaceutical benefits and related information

Listed drug

Form

Manner of administration

Brand

Circumstances

Purposes

Maximum quantity

Maximum repeats

Abacavir

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

Oral

Ziagen

C4454 C4512

 

8

5

 

Tablet 300 mg (as sulfate)

Oral

Ziagen

C4454 C4512

 

120

5

Abacavir with Lamivudine

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

Oral

Abacavir/Lamivudine GH 600/300

C4527 C4528

 

60

5

 

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

Oral

ABACAVIR/LAMIVUDINE 600/300 SUN

C4527 C4528

 

60

5

 

 

 

Abacavir/
Lamivudine Mylan

C4527 C4528

 

60

5

 

 

 

Kivexa

C4527 C4528

 

60

5

Abacavir with Lamivudine and Zidovudine

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

Oral

Trizivir

C4480 C4495

 

120

5

Abatacept

Powder for I.V. infusion 250 mg

Injection

Orencia

C8627 C8638 C8655 C8748 C11795 C11806 C12372 C12375 C12384

 

See Schedule 2

See Schedule 2

Adalimumab

Injection 20 mg in 0.2 mL pre‑filled syringe

Injection

Humira

C12111 C12112 C12114 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

Injection 20 mg in 0.4 mL pre‑filled syringe

Injection

Amgevita

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

Injection 40 mg in 0.4 mL pre‑filled pen

Injection

Humira

C12111 C12112 C12114 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

Injection 40 mg in 0.4 mL pre‑filled syringe

Injection

Humira

C12111 C12112 C12114 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

Injection 40 mg in 0.8 mL pre‑filled pen

Injection

Amgevita

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

 

 

Hadlima

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

 

 

Hyrimoz

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

 

 

Idacio

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

Injection 40 mg in 0.8 mL pre‑filled syringe

Injection

Amgevita

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

 

 

Hadlima

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

 

 

Hyrimoz

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

 

 

 

Idacio

C11526 C12111 C12112 C12114 C12116 C12117 C12120 C12166 C12169 C12355 C12373

 

See Schedule 2

See Schedule 2

Adefovir

Tablet containing adefovir dipivoxil 10 mg

Oral

APO‑Adefovir

C4490 C4510

 

60

5

Alemtuzumab

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

Injection

Lemtrada

C6847 C7714 C9589 C9636

P6847 P9589

3

0

 

 

 

 

C6847 C7714 C9589 C9636

P7714 P9636

5

0

Ambrisentan

Tablet 5 mg

Oral

Ambrisentan Mylan

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

 

 

 

Cipla Ambrisentan

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

 

 

 

PULMORIS

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

 

 

 

Volibris

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

 

Tablet 10 mg

Oral

Ambrisentan Mylan

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

 

 

 

Cipla Ambrisentan

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

 

 

 

PULMORIS

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

 

 

 

Volibris

C11229 C11312 C11313 C11314 C12433 C12446 C12447 C12460

 

See Schedule 2

See Schedule 2

Anakinra

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

Injection

Kineret

C5450

 

28

5

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 20 mg in 2 mL

Injection

Movapo

C11385 C11445

 

360

5

 

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

Injection

Movapo

C11385 C11445

 

180

5

 

Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

Injection

Apomine Solution for Infusion

C10830 C10863

 

90

5

 

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

Injection

Movapo PFS

C11385 C11445

 

180

5

 

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre‑filled pen

Injection

Apomine Intermittent

C10830 C10863

 

100

5

 

 

 

Movapo Pen

C10830 C10863

 

100

5

Atazanavir

Capsule 200 mg (as sulfate)

Oral

Reyataz

C4454 C4512

 

120

5

 

Capsule 300 mg (as sulfate)

Oral

Reyataz

C4454 C4512

 

60

5

Atazanavir with cobicistat

Tablet containing 300 mg atazanavir and 150 mg cobicistat

Oral

Evotaz

C4454 C4512

 

60

5

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine Accord

C6132 C6143 C6144 C6177 C6186 C6199 C12439

 

See Schedule 2

See Schedule 2

 

 

 

AZACITIDINE DR.REDDY’S

C6132 C6143 C6144 C6177 C6186 C6199 C12439

 

See Schedule 2

See Schedule 2

 

 

 

Azacitidine Juno

C6132 C6143 C6144 C6177 C6186 C6199 C12439

 

See Schedule 2

See Schedule 2

 

 

 

Azacitidine MSN

C6132 C6143 C6144 C6177 C6186 C6199 C12439

 

See Schedule 2

See Schedule 2

 

 

 

Azacitidine‑Teva

C6132 C6143 C6144 C6177 C6186 C6199 C12439

 

See Schedule 2

See Schedule 2

 

 

 

Azadine

C6132 C6143 C6144 C6177 C6186 C6199 C12439

 

See Schedule 2

See Schedule 2

Azithromycin

Tablet 600 mg (as dihydrate)

Oral

Zithromax

C6356 C9604

 

16

5

Baclofen

Intrathecal injection 10 mg in 5 mL

Injection

Bacthecal

C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637

 

10

0

 

 

 

Lioresal Intrathecal

C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637

 

10

0

 

 

 

Sintetica Baclofen Intrathecal

C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637

 

10

0

 

Intrathecal injection 40 mg in 20 mL

Injection

Sintetica Baclofen Intrathecal

C7134 C7148 C7152 C7153 C9525 C9562 C9606 C9638

 

2

0

Benralizumab

Injection 30 mg in 1 mL single dose pre‑filled pen

Injection

Fasenra Pen

C11841 C11842 C11892 C11893

 

See Schedule 2

See Schedule 2

 

Injection 30 mg in 1 mL single dose pre‑filled syringe

Injection

Fasenra

C11841 C11842 C11892 C11893

 

See Schedule 2

See Schedule 2

Bictegravir with emtricitabine with tenofovir alafenamide

Tablet containing bictegravir 50 mg with emtricitabine 200 mg with tenofovir alafenamide 25 mg

Oral

Biktarvy

C4470 C4522

 

60

5

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

Bosentan APO

C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Bosentan Cipla

C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

BOSENTAN DR.REDDY’S

C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Bosentan Mylan

C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Bosentan RBX

C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

BOSLEER

C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Tracleer

C11229 C11312 C11313 C11314 C12406 C12423 C12425 C12427 C12458

 

See Schedule 2

See Schedule 2

 

Tablet 125 mg (as monohydrate)

Oral

Bosentan APO

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Bosentan Cipla

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

BOSENTAN DR.REDDY’S

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Bosentan GH

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Bosentan Mylan

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Bosentan RBX

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

BOSLEER

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

 

 

 

Tracleer

C11229 C11312 C11313 C11314 C12406 C12423 C12427 C12458

 

See Schedule 2

See Schedule 2

Cabotegravir

Tablet 30 mg

Oral

Vocabria

C12619

 

30

0

Cabotegravir and rilpivirine

Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3 mL

Injection

Cabenuva

C12636

 

1

5

Ciclosporin

Capsule 10 mg

Oral

Neoral 10

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

Capsule 25 mg

Oral

APO‑Ciclosporin

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

 

 

Cyclosporin Sandoz

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

 

 

Neoral 25

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

Capsule 50 mg

Oral

APO‑Ciclosporin

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

 

 

Cyclosporin Sandoz

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

 

 

Neoral 50

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

Capsule 100 mg

Oral

APO‑Ciclosporin

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

 

 

Cyclosporin Sandoz

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

 

 

Neoral 100

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

120

5

 

Oral liquid 100 mg per mL, 50 mL

Oral

Neoral

C6631 C6638 C6643 C6660 C6676 C9694 C9695 C9742 C9763 C9764

 

4

5

 

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

Injection

Sandimmun

C6628 C9831

 

10

0

Cinacalcet

Tablet 30 mg (as hydrochloride)

Oral

Cinacalcet Mylan

C10063 C10067 C10073

 

56

5

 

 

 

Pharmacor Cinacalcet

C10063 C10067 C10073

 

56

5

 

Tablet 60 mg (as hydrochloride)

Oral

Cinacalcet Mylan

C10063 C10067 C10073

 

56

5

 

 

 

Pharmacor Cinacalcet

C10063 C10067 C10073

 

56

5

 

Tablet 90 mg (as hydrochloride)

Oral

Cinacalcet Mylan

C10063 C10067 C10073

 

56

5

 

 

 

Pharmacor Cinacalcet

C10063 C10067 C10073

 

56

5

Clozapine

Oral liquid 50 mg per mL, 100 mL

Oral

Clopine Suspension

C4998 C5015 C9490

 

1

0

 

 

 

Versacloz

C4998 C5015 C9490

 

1

0

 

Tablet 25 mg

Oral

Clopine 25

C4998 C5015 C9490

 

200

0

 

 

 

Clozaril 25

C4998 C5015 C9490

 

200

0

 

 

 

Clozitor

C4998 C5015 C9490

 

200

0

 

Tablet 50 mg

Oral

Clopine 50

C4998 C5015 C9490

 

200

0

 

 

 

Clozitor

C4998 C5015 C9490

 

200

0

 

Tablet 100 mg

Oral

Clopine 100

C4998 C5015 C9490

 

200

0

 

 

 

Clozaril 100

C4998 C5015 C9490

 

200

0

 

 

 

Clozitor

C4998 C5015 C9490

 

200

0

 

Tablet 200 mg

Oral

Clopine 200

C4998 C5015 C9490

 

200

0

 

 

 

Clozitor

C4998 C5015 C9490

 

200

0

Darbepoetin alfa

Injection 10 micrograms in 0.4 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 20 micrograms in 0.5 mL pre‑filled injection pen

Injection

Aranesp SureClick

C6294 C9688

 

8

5

 

Injection 20 micrograms in 0.5 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 30 micrograms in 0.3 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 40 micrograms in 0.4 mL pre‑filled injection pen

Injection

Aranesp SureClick

C6294 C9688

 

8

5

 

Injection 40 micrograms in 0.4 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 50 micrograms in 0.5 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 60 micrograms in 0.3 mL pre‑filled injection pen

Injection

Aranesp SureClick

C6294 C9688

 

8

5

 

Injection 60 micrograms in 0.3 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 80 micrograms in 0.4 mL pre‑filled injection pen

Injection

Aranesp SureClick

C6294 C9688

 

8

5

 

Injection 80 micrograms in 0.4 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 100 micrograms in 0.5 mL pre‑filled injection pen

Injection

Aranesp SureClick

C6294 C9688

 

8

5

 

Injection 100 micrograms in 0.5 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

 

Injection 150 micrograms in 0.3 mL pre‑filled injection pen

Injection

Aranesp SureClick

C6294 C9688

 

8

5

 

Injection 150 micrograms in 0.3 mL pre‑filled syringe

Injection

Aranesp

C6294 C9688

 

8

5

Darunavir

Tablet 600 mg

Oral

Darunavir Juno

C5094

 

120

5

 

Tablet 600 mg (as ethanolate)

Oral

Prezista

C5094

 

120

5

 

Tablet 800 mg

Oral

Darunavir Juno

C4313

 

60

5

 

Tablet 800mg (as ethanolate)

Oral

Prezista

C4313

 

60

5

Darunavir with cobicistat

Tablet containing darunavir 800mg with cobicistat 150 mg

Oral

Prezcobix

C6377 C6413 C6428

 

60

5

Darunavir with cobicistat, emtricitabine and tenofovir alafenamide

Tablet containing darunavir
800 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg

Oral

Symtuza

C10317 C10324

 

60

5

Deferasirox

Tablet 90 mg

Oral

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Deferasirox ARX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Deferasirox Sandoz

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

DEFERASIROX‑TEVA

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Eferas

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Jadenu

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Pharmacor Deferasirox FC

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Deferasirox ARX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Deferasirox Sandoz

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

DEFERASIROX‑TEVA

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Eferas

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Jadenu

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Pharmacor Deferasirox FC

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

Tablet 180 mg

Oral

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Deferasirox ARX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Deferasirox Sandoz

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

DEFERASIROX‑TEVA

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Eferas

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Jadenu

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Pharmacor Deferasirox FC

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Deferasirox ARX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Deferasirox Sandoz

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

DEFERASIROX‑TEVA

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Eferas

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Jadenu

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Pharmacor Deferasirox FC

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

Tablet 360 mg

Oral

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Deferasirox ARX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Deferasirox Sandoz

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

DEFERASIROX‑TEVA

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Eferas

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Jadenu

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

Pharmacor Deferasirox FC

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

2

 

 

 

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Deferasirox ARX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Deferasirox Sandoz

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

DEFERASIROX‑TEVA

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Eferas

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Jadenu

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

 

 

Pharmacor Deferasirox FC

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

5

 

Tablet, dispersible, 125 mg

Oral

Deferasirox Juno

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

 

 

 

 

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

 

Tablet, dispersible, 250 mg

Oral

Deferasirox Juno

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

 

 

 

 

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

 

Tablet, dispersible, 500 mg

Oral

Deferasirox Juno

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

168

2

 

 

 

 

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

168

5

Deferiprone

Oral solution 100 mg per mL, 250 mL

Oral

Ferriprox

C6403 C6448 C9228 C9286

 

5

5

 

Tablet 500 mg

Oral

Ferriprox

C6403 C6448 C9228 C9286

 

300

5

 

Tablet 1000 mg

Oral

Ferriprox

C6403 C6448 C9590 C9623

 

300

5

Desferrioxamine

Powder for injection containing desferrioxamine mesilate 500 mg

Injection

DBL Desferrioxamine Mesilate

C6394 C9696

 

400

5

 

Powder for injection containing desferrioxamine mesilate 2 g

Injection

DBL Desferrioxamine Mesilate

C6394 C9696

 

60

5

Dolutegravir

Tablet 50mg (as sodium)

Oral

Tivicay

C4454 C4512

 

60

5

Dolutegravir with abacavir and lamivudine

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

Oral

Triumeq

C9981 C10116

 

60

5

Dolutegravir with lamivudine

Tablet containing dolutegravir
50 mg (as sodium) with lamivudine 300 mg

Oral

Dovato

C9987 C11066

 

60

5

Dolutegravir with rilpivirine

Tablet containing dolutegravir 50 mg (as sodium) with rilpivirine 25 mg (as hydrochloride)

Oral

Juluca

C8214 C8226

 

60

5

Dornase Alfa

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

Inhalation

Pulmozyme

C5634 C5635 C5740 C9591 C9592 C9624

 

60

5

Doxorubicin ‑
Pegylated Liposomal

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

Injection

Caelyx

C6234 C6274 C9223 C9287

 

4

5

 

 

 

Liposomal Doxorubicin SUN

C6234 C6274 C9223 C9287

 

4

5

Dupilumab

Injection 200 mg in 1.14 mL single dose pre‑filled syringe

Injection

Dupixent

C11897 C11924 C11964

 

See Schedule 2

See Schedule 2

 

Injection 300 mg in 2 mL single dose pre‑filled syringe

Injection

Dupixent

C11844 C11924 C11926

 

See Schedule 2

See Schedule 2

Eculizumab

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

Injection

Soliris

C6626 C6637 C6642 C6668 C6686 C6687 C6688 C12944 C12945 C12953 C12954 C12955 C12964 C12969

 

See Schedule 2

See Schedule 2

Efavirenz

Tablet 200 mg

Oral

Stocrin

C4454 C4512

 

180

5

 

Tablet 600 mg

Oral

Stocrin

C4454 C4512

 

60

5

Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg

Oral

Trikafta

C12962 C12972

 

See Schedule 2

See Schedule 2

Eltrombopag

Tablet 25 mg (as olamine)

Oral

Revolade

C11199 C11202 C11244 C11262 C11263

 

See Schedule 2

See Schedule 2

 

Tablet 50 mg (as olamine)

Oral

Revolade

C11199 C11202 C11244 C11262 C11263

 

See Schedule 2

See Schedule 2

Emtricitabine with rilpivirine with tenofovir alafenamide

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

Oral

Odefsey

C4470 C4522

 

60

5

Emtricitabine with tenofovir alafenamide

Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg

Oral

Descovy

C4454 C4512

 

60

5

 

Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg

Oral

Descovy

C4454 C4512

 

60

5

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

C5014

 

2

5

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

ENTAC

C4993 C5036

 

60

5

 

 

 

ENTECAVIR APO

C4993 C5036

 

60

5

 

 

 

Entecavir GH

C4993 C5036

 

60

5

 

 

 

Entecavir Mylan

C4993 C5036

 

60

5

 

 

 

ENTECAVIR RBX

C4993 C5036

 

60

5

 

 

 

Entecavir Sandoz

C4993 C5036

 

60

5

 

 

 

ENTECLUDE

C4993 C5036

 

60

5

 

Tablet 1 mg (as monohydrate)

Oral

ENTAC

C5037 C5044

 

60

5

 

 

 

ENTECAVIR APO

C5037 C5044

 

60

5

 

 

 

Entecavir GH

C5037 C5044

 

60

5

 

 

 

Entecavir Mylan

C5037 C5044

 

60

5

 

 

 

ENTECAVIR RBX

C5037 C5044

 

60

5

 

 

 

Entecavir Sandoz

C5037 C5044

 

60

5

 

 

 

ENTECLUDE

C5037 C5044

 

60

5

Epoetin Alfa

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

Injection

Eprex 1000

C6294 C9688

 

12

5

 

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

Injection

Eprex 2000

C6294 C9688

 

12

5

 

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

Injection

Eprex 3000

C6294 C9688

 

12

5

 

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

Injection

Eprex 4000

C6294 C9688

 

12

5

 

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

Injection

Eprex 5000

C6294 C9688

 

12

5

 

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

Injection

Eprex 6000

C6294 C9688

 

12

5

 

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

Injection

Eprex 8000

C6294 C9688

 

12

5

 

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

Injection

Eprex 10000

C6294 C9688

 

12

5

 

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

Injection

Eprex 20,000

C6294 C9688

 

12

5

 

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

Injection

Eprex 40,000

C6294 C9688

 

2

5

Epoetin Beta

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

Injection

NeoRecormon

C6294 C9688

 

12

5

 

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

Injection

NeoRecormon

C6294 C9688

 

12

5

 

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

Injection

NeoRecormon

C6294 C9688

 

12

5

 

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

Injection

NeoRecormon

C6294 C9688

 

12

5

 

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

Injection

NeoRecormon

C6294 C9688

 

12

5

 

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

Injection

NeoRecormon

C6294 C9688

 

12

5

Epoetin lambda

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

Injection

Novicrit

C6294 C9688

 

12

5

 

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

Injection

Novicrit

C6294 C9688

 

12

5

 

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

Injection

Novicrit

C6294 C9688

 

12

5

 

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

Injection

Novicrit

C6294 C9688

 

12

5

 

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

Injection

Novicrit

C6294 C9688

 

12

5

 

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

Injection

Novicrit

C6294 C9688

 

12

5

 

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

Injection

Novicrit

C6294 C9688

 

12

5

 

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

Injection

Novicrit

C6294 C9688

 

12

5

Epoprostenol

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

Injection

EPOPROSTENOL SUN

C11322 C11323 C11329 C11330 C11345 C11356 C12411 C12454

 

See Schedule 2

See Schedule 2

 

 

 

Veletri

C11322 C11323 C11329 C11330 C11345 C11356 C12411 C12454

 

See Schedule 2

See Schedule 2

 

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

Injection

Flolan

C11322 C11323 C11329 C11330 C11345 C11356 C12411 C12454

 

See Schedule 2

See Schedule 2

 

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

Injection

EPOPROSTENOL SUN

C11322 C11323 C11329 C11330 C11345 C11356 C12411 C12454

 

See Schedule 2

See Schedule 2

 

 

 

Veletri

C11322 C11323 C11329 C11330 C11345 C11356 C12411 C12454

 

See Schedule 2

See Schedule 2

 

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

Injection

Flolan

C11322 C11323 C11329 C11330 C11345 C11356 C12411 C12454

 

See Schedule 2

See Schedule 2

Etanercept

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

Injection

Enbrel

C9384 C9417 C10548 C10578 C10579 C10599 C12357 C12407

 

1

0

 

Injection 50 mg in 1 mL single use dose‑dispenser cartridges, 4

Injection

Enbrel

C9384 C9417 C10548 C10578 C10579 C10599 C12357 C12407

 

1

0

 

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

Injection

Enbrel

C9384 C9417 C10548 C10578 C10579 C10599 C12357 C12407

 

1

0

 

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

Injection

Enbrel

C9384 C9417 C10548 C10578 C10579 C10599 C12357 C12407

 

1

0

Etravirine

Tablet 200 mg

Oral

Intelence

C5014

 

120

5

Everolimus

Tablet 0.25 mg

Oral

Certican

C5554 C5795 C9691 C9693

 

120

5

 

 

 

Everocan

C5554 C5795 C9691 C9693

 

120

5

 

Tablet 0.5 mg

Oral

Certican

C5554 C5795 C9691 C9693

 

120

5

 

 

 

Everocan

C5554 C5795 C9691 C9693

 

120

5

 

Tablet 0.75 mg

Oral

Certican

C5554 C5795 C9691 C9693

 

240

5

 

 

 

Everocan

C5554 C5795 C9691 C9693

 

240

5

 

Tablet 1 mg

Oral

Certican

C5554 C5795 C9691 C9693

 

240

5

 

 

 

Everocan

C5554 C5795 C9691 C9693

 

240

5

Filgrastim

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

Injection

Nivestim

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

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

Injection

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

 

 

Nivestim

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

 

 

Zarzio

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

Injection 300 micrograms in 1 mL

Injection

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

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

Injection

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

 

 

Nivestim

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

 

 

Zarzio

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

 

Injection 480 micrograms in 1.6 mL

Injection

Neupogen

C6621 C6640 C6653 C6654 C6655 C6679 C6680 C7822 C7843 C8667 C8668 C8669 C8670 C8671 C8672 C8673 C8674 C8696

 

20

11

Fosamprenavir

Tablet 700 mg (as calcium)

Oral

Telzir

C4454 C4512

 

120

5

Ganciclovir

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

Injection

Cymevene

C4972 C4999 C5000 C9404 C9526

 

10

1

 

 

 

GANCICLOVIR SXP

C4972 C4999 C5000 C9404 C9526

 

10

1

Glecaprevir with pibrentasvir

Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir

Oral

Maviret

C7593 C7615 C10268

P7593

84

1

 

 

 

 

C7593 C7615 C10268

P7615

84

2

 

 

 

 

C7593 C7615 C10268

P10268

84

3

Ibandronic acid

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

Injection

Bondronat

C5291 C9333

 

1

11

Iloprost

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

Inhalation

Ventavis

C10229 C11322 C11323 C11325 C11343 C11345 C11356 C11365

 

See Schedule 2

See Schedule 2

Infliximab

Powder for I.V. infusion 100 mg

Injection

Inflectra

C4524 C7777 C8296 C8646 C8745 C8800 C8844 C8881 C8883 C8886 C8940 C8941 C8962 C8983 C9065 C9067 C9068 C9110 C9111 C9169 C9188 C9191 C9400 C9401 C9402 C9472 C9481 C9487 C9558 C9559 C9584 C9587 C9602 C9621 C9632 C9668 C9669 C9677 C9719 C9721 C9732 C9751 C9752 C9754 C9775 C9779 C9783 C9787 C9799 C9803 C9877 C9900 C9994 C11094 C11095 C11111 C11112 C11127 C11128 C11129 C11158 C11159 C12003 C12004 C12007 C12024 C12025 C12039 C12042 C12043 C12049 C12051 C12058 C12059 C12061 C12063 C12067 C12069 C12074 C12075 C12076 C12313 C12361 C12362

 

See Schedule 2

See Schedule 2

 

 

 

Remicade

C4524 C7777 C8296 C8646 C8745 C8800 C8881 C8883 C8886 C8941 C8962 C8983 C9065 C9067 C9068 C9110 C9111 C9169 C9191 C9400 C9401 C9402 C9487 C9558 C9559 C9587 C9632 C9669 C9677 C9719 C9721 C9751 C9752 C9754 C9779 C9783 C9799 C9803 C9877 C9900 C9994 C11094 C11095 C11111 C11112 C11127 C11128 C11129 C11158 C11159 C12003 C12004 C12007 C12024 C12025 C12039 C12043 C12049 C12058 C12059 C12061 C12063 C12076 C12313 C12361 C12362

 

See Schedule 2

See Schedule 2

 

 

 

Renflexis

C4524 C7777 C8296 C8646 C8745 C8800 C8844 C8881 C8883 C8886 C8940 C8941 C8962 C8983 C9065 C9067 C9068 C9110 C9111 C9169 C9188 C9191 C9400 C9401 C9402 C9472 C9481 C9487 C9558 C9559 C9584 C9587 C9602 C9621 C9632 C9668 C9669 C9677 C9719 C9721 C9732 C9751 C9752 C9754 C9775 C9779 C9783 C9787 C9799 C9803 C9877 C9900 C9994 C11094 C11095 C11111 C11112 C11127 C11128 C11129 C11158 C11159 C12003 C12004 C12007 C12024 C12025 C12039 C12042 C12043 C12049 C12051 C12058 C12059 C12061 C12063 C12067 C12069 C12074 C12075 C12076 C12313 C12361 C12362

 

See Schedule 2

See Schedule 2

Interferon Gamma‑1b

Injection 2,000,000 I.U. in 0.5 mL

Injection

Imukin

C6222 C9639

 

12

11

Ivacaftor

Sachet containing granules
50 mg

Oral

Kalydeco

C12624 C12625

 

See Schedule 2

See Schedule 2

 

Sachet containing granules
75 mg

Oral

Kalydeco

C12624 C12625

 

See Schedule 2

See Schedule 2

 

Tablet 150 mg

Oral

Kalydeco

C12624 C12625

 

See Schedule 2

See Schedule 2

Lamivudine

Oral solution 10 mg per mL, 240 mL

Oral

3TC

C4454 C4512

 

8

5

 

Tablet 100 mg

Oral

Zeffix

C4993 C5036

 

56

5

 

 

 

Zetlam

C4993 C5036

 

56

5

 

Tablet 150 mg

Oral

3TC

C4454 C4512

 

120

5

 

 

 

Lamivudine Alphapharm

C4454 C4512

 

120

5

 

Tablet 300 mg

Oral

3TC

C4454 C4512

 

60

5

 

 

 

Lamivudine Alphapharm

C4454 C4512

 

60

5

Lamivudine with Zidovudine

Tablet 150 mg‑300 mg

Oral

Combivir

C4454 C4512

 

120

5

 

 

 

Lamivudine 150 mg + Zidovudine 300 mg Alphapharm

C4454 C4512

 

120

5

Lanreotide

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

Injection

Somatuline Autogel

C4575 C7025 C7509 C7532 C9260 C9261

 

2

5

 

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

Injection

Somatuline Autogel

C4575 C7025 C7509 C7532 C9260 C9261

 

2

5

 

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

Injection

Somatuline Autogel

C4575 C7025 C7509 C7532 C9260 C9261 C10061 C10075 C10077

 

2

5

Lanthanum

Tablet, chewable, 500 mg (as carbonate hydrate)

Oral

Fosrenol

C5530 C9762

 

180

5

 

Tablet, chewable, 750 mg (as carbonate hydrate)

Oral

Fosrenol

C5530 C9762

 

180

5

 

Tablet, chewable, 1000 mg (as carbonate hydrate)

Oral

Fosrenol

C5530 C9762

 

180

5

Ledipasvir with sofosbuvir

Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir

Oral

Harvoni

C5944 C5969 C5972

P5944

28

1

 

 

 

 

C5944 C5969 C5972

P5969

28

2

 

 

 

 

C5944 C5969 C5972

P5972

28

5

Lenalidomide

Capsule 5 mg

Oral

Revlimid

C4282 C4287 C10334 C10335 C10373 C10427 C10428 C10429 C10452 C10453 C12689 C12840 C12841

 

See Schedule 2

See Schedule 2

 

Capsule 10 mg

Oral

Revlimid

C4282 C4287 C10334 C10335 C10373 C10427 C10428 C10429 C10452 C10453 C12689 C12840 C12841

 

See Schedule 2

See Schedule 2

 

Capsule 15 mg

Oral

Revlimid

C10334 C10335 C10373 C10427 C10428 C10429 C10452 C10453 C12689 C12840 C12841

 

See Schedule 2

See Schedule 2

 

Capsule 25 mg

Oral

Revlimid

C10373 C10427 C10428 C10429 C10452 C10453 C12689 C12840 C12841

 

See Schedule 2

See Schedule 2

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL,
100 mL

Intra‑
intestinal

Duodopa

C10138 C10161 C10363 C10375

P10138 P10161

28

5

 

 

 

 

C10138 C10161 C10363 C10375

P10363 P10375

56

5

Lipegfilgrastim

 

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

Injection

Lonquex

C7822 C7843 C9224 C9322

 

1

11

Lopinavir with ritonavir

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

Oral

Kaletra

C4454 C4512

 

10

5

 

Tablet 100 mg‑25 mg

Oral

Kaletra

C4454 C4512

 

120

5

 

Tablet 200 mg‑50 mg

Oral

Kaletra

C4454 C4512

 

240

5

Lumacaftor with ivacaftor

Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg

Oral

Orkambi

C12610 C12621

 

See Schedule 2

See Schedule 2

 

Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg

Oral

Orkambi

C12610 C12621

 

See Schedule 2

See Schedule 2

 

Tablet containing lumacaftor
100 mg with ivacaftor 125 mg

Oral

Orkambi

C12627 C12633

 

See Schedule 2

See Schedule 2

 

Tablet containing lumacaftor
200 mg with ivacaftor 125 mg

Oral

Orkambi

C12612 C12623

 

See Schedule 2

See Schedule 2

Macitentan

Tablet 10 mg

Oral

Opsumit

C11229 C11312 C11313 C11314 C12402 C12403 C12420 C12463

 

See Schedule 2

See Schedule 2

Mannitol

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

Inhalation by mouth

Bronchitol

C7362 C7367 C9527 C9593

 

4

5

Maraviroc

Tablet 150 mg

Oral

Celsentri

C5008

 

120

5

 

Tablet 300 mg

Oral

Celsentri

C5008

 

120

5

Mepolizumab

Injection 100 mg in 1 mL single dose pre‑filled pen

Injection

Nucala

C11841 C11842 C11848 C11950

 

See Schedule 2

See Schedule 2

 

Powder for injection 100 mg

Injection

Nucala

C11841 C11842 C11848 C11950

 

See Schedule 2

See Schedule 2

Methoxsalen

Solution for blood fraction 20 microgram per mL, 10 mL

Extracorporeal Circulation

Uvadex

C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579

P10988 P10989

1

5

 

 

 

 

C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579

P12531 P12567

2

0

 

 

 

 

C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579

P10971 P10985

2

6

 

 

 

 

C10971 C10985 C10988 C10989 C12531 C12546 C12567 C12579

P12546 P12579

12

1

Methoxy polyethylene glycol‑epoetin beta

Injection 30 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

C6294 C9688

 

2

5

 

Injection 50 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

C6294 C9688

 

2

5

 

Injection 75 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

C6294 C9688

 

2

5

 

Injection 100 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

C6294 C9688

 

2

5

 

Injection 120 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

C6294 C9688

 

2

5

 

Injection 200 micrograms in 0.3 mL pre‑filled syringe

Injection

Mircera

C6294 C9688

 

2

5

 

Injection 360 micrograms in 0.6 mL pre‑filled syringe

Injection

Mircera

C6294 C9688

 

2

5

Midostaurin

Capsule 25 mg

Oral

Rydapt

C11699 C11801 C11814

 

See Schedule 2

See Schedule 2

Mycophenolic acid

Capsule containing mycophenolate mofetil 250 mg

Oral

APO‑Mycophenolate

C5600 C5653 C9689 C9690

 

600

5

 

 

 

CellCept

C5600 C5653 C9689 C9690

 

600

5

 

 

 

Ceptolate

C5600 C5653 C9689 C9690

 

600

5

 

 

 

Mycophenolate Sandoz

C5600 C5653 C9689 C9690

 

600

5

 

 

 

Pharmacor Mycophenolate 250

C5600 C5653 C9689 C9690

 

600

5

 

Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL

Oral

CellCept

C5554 C5795 C9691 C9693

 

2

5

 

Tablet containing mycophenolate mofetil 500 mg

Oral

CellCept

C5554 C5795 C9691 C9693

 

300

5

 

 

 

Ceptolate

C5554 C5795 C9691 C9693

 

300

5

 

 

 

MycoCept

C5554 C5795 C9691 C9693

 

300

5

 

 

 

Mycophenolate APOTEX

C5554 C5795 C9691 C9693

 

300

5

 

 

 

Mycophenolate GH

C5554 C5795 C9691 C9693

 

300

5

 

 

 

Mycophenolate Sandoz

C5554 C5795 C9691 C9693

 

300

5

 

 

 

Pharmacor Mycophenolate 500

C5554 C5795 C9691 C9693

 

300

5

 

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

Oral

Myfortic

C4084 C4095 C9692 C9809

 

240

5

 

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

Oral

Myfortic

C4084 C4095 C9692 C9809

 

240

5

Natalizumab

Solution concentrate for I.V. infusion 300 mg in 15 mL

Injection

Tysabri

C9744 C9818

 

1

5

Nevirapine

Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL

Oral

Viramune

C4454 C4512

 

10

5

 

Tablet 200 mg

Oral

Nevirapine Alphapharm

C4454 C4512

 

120

5

 

Tablet 400 mg (extended release)

Oral

Viramune XR

C4454 C4526

 

60

5

Nusinersen

Solution for injection 12 mg in 5 mL

Injection

Spinraza

C12643 C12667 C12672 C12676

 

See Schedule 2

See Schedule 2

Ocrelizumab

Solution concentrate for I.V. infusion 300 mg in 10 mL

Injection

Ocrevus

C7386 C7699 C9523 C9635

 

2

0

Octreotide

Injection 50 micrograms (as acetate) in 1 mL

Injection

Octreotide GH

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Octreotide MaxRx

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Octreotide (SUN)

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Sandostatin 0.05

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

Injection 100 micrograms (as acetate) in 1 mL

Injection

Octreotide GH

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Octreotide MaxRx

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Octreotide (SUN)

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Sandostatin 0.1

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

Injection 500 micrograms (as acetate) in 1 mL

Injection

Octreotide GH

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Octreotide MaxRx

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Octreotide (SUN)

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

 

 

Sandostatin 0.5

C6369 C6390 C8165 C9232 C9233 C9289

 

90

11

 

Injection (modified release) 10 mg (as acetate), vial and diluent syringe

Injection

Octreotide Depot

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313

 

2

5

 

 

 

Sandostatin LAR

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313

 

2

5

 

Injection (modified release) 20 mg (as acetate), vial and diluent syringe

Injection

Octreotide Depot

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313

 

2

5

 

 

 

Sandostatin LAR

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313

 

2

5

 

Injection (modified release) 30 mg (as acetate), vial and diluent syringe

Injection

Octreotide Depot

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313 C10061 C10075 C10077

 

2

5

 

 

 

Sandostatin LAR

C5901 C5906 C8161 C8197 C8198 C8208 C9262 C9288 C9313 C10061 C10075 C10077

 

2

5

Omalizumab

Injection 75 mg in 0.5 mL single dose pre‑filled syringe

Injection

Xolair

C10223 C10226 C10265 C11841 C11846 C11847 C11902

 

See Schedule 2

See Schedule 2

 

Injection 150 mg in 1 mL single dose pre‑filled syringe

Injection

Xolair

C7046 C7055 C10223 C10226 C10265 C11841 C11846 C11847 C11902

 

See Schedule 2

See Schedule 2

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

 

Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C12641

 

See Schedule 2

See Schedule 2

Pamidronic Acid

Concentrated injection containing pamidronate disodium 15 mg in 5 mL

Injection

Pamisol

C4433 C9234

 

4

2

 

Concentrated injection containing pamidronate disodium 30 mg in 10 mL

Injection

Pamisol

C4433 C9234

 

2

2

 

Concentrated injection containing pamidronate disodium 60 mg in 10 mL

Injection

Pamisol

C4433 C9234

 

1

2

 

Concentrated injection containing pamidronate disodium 90 mg in 10 mL