National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023 (Cth)

Case

PB 57 of 2023

National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023

I, Adriana Platona, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated               23 June 2023

Adriana Platona
First Assistant Secretary
Technology Assessment and Access Division

Department of Health and Aged Care

Contents

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

2............ Commencement............................................................................................................. 1

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

4............ Schedules...................................................................................................................... 1

Schedule 1—Opioid dependence treatment  2

National Health (Highly Specialised Drugs Program) Special Arrangement 2021             2

Schedule 2—Maximum dispensed quantities  13

National Health (Listing of Pharmaceutical Benefits) Instrument 2012  13

1  Name

(1)  This instrument is the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023.

(2)  This instrument may also be cited as PB 57 of 2023.

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table 1 July 2023. 1 July 2023
2.  Schedule 1 1 July 2023. 1 July 2023
3.  Schedule 2 1 September 2023. 1 September 2023

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88, 99 and 100 of the National Health Act 1953.

4  Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Opioid dependence treatment

National Health (Highly Specialised Drugs Program) Special Arrangement 2021

1  Section 6

Insert:

Approved Pharmacists Commonwealth Price Determination means the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.

Approved Pharmacists Conditions Determination means the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.

2  Section 6 (after paragraph (b) of the definition of community access medication)

Insert:

(ba)  medication for the treatment of opioid dependence;

3  Section 6

Insert:

dangerous drug has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

dangerous drug fee has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.

medication for the treatment of opioid dependence means any of the following:

(a)  buprenorphine;

(b)  buprenorphine with naloxone;

(c)  methadone.

ODT pharmaceutical benefit means an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of opioid dependence.

4  Section 6 (definition of shelf life)

Repeal the definition.

5  Section 6 (definition of special arrangement supply)

Omit “section 13”, substitute “sections 13 and 41”.

6  Paragraph 7(4)(a)

Before “a medication”, insert “a benefit that has a drug that is”.

7  Paragraph 7(4)(b)

Before “lanreotide”, insert “a benefit that has the drug”.

8  Paragraph 7(4)(c)

Before “octreotide”, insert “a benefit that has the drug”.

9  Subsection 7(5)

Repeal the subsection, substitute:

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

(5)  The following table has effect.

Authorised prescribers for certain HSD pharmaceutical benefits
Item Column 1
The following person … 		Column 2
is an authorised prescriber for an HSD pharmaceutical benefit that has a drug that is …
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.

10  At the end of section 7

Add:

Authorised nurse practitioners and medical practitioners—ODT pharmaceutical benefits

(6)  Each of the following is an authorised prescriber for an ODT pharmaceutical benefit:

(a)  an authorised nurse practitioner;

(b)  a medical practitioner.

11  Subsection 8(2)

Before “is a medication”, insert “has a drug that”.

12  Subsection 8(3)

Omit “contains”, substitute “has the drug”.

13  Subsection 8(5)

Before “is a medication”, insert “has a drug that”.

14  Subsection 8(6) (heading)

Before “are”, insert “have drugs that”.

15  Paragraph 8(6)(a)

After “benefit”, insert “has a drug that”.

16  Paragraph 13(3)(a)

After “benefit”, insert “has a drug that”.

17  Subsection 14(2)

Repeal the subsection, substitute:

(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 the following:

(a)  a benefit that has a drug that is a medication for the treatment of hepatitis C;

(b)  a benefit that has the drug methadone.

18  At the end of section 14

Add:

(4)  Subsection 9(4) of the Listing Instrument (which provides for the pharmaceutical benefits for which authorised nurse practitioners are authorised to write prescriptions) does not apply to an HSD pharmaceutical benefit other than the following:

(a)  a benefit that has a drug that is a medication for the treatment of hepatitis C;

(b)  a benefit that has the drug methadone.

19  Before subsection 20(5)

Insert:

Application of this section

20  Before subsection 21(5)

Insert:

Application of this section

21  Section 23 (heading)

Omit “contain”, substitute “have”.

22  Subsection 23(1)

Omit “contains”, substitute “has the drug”.

23  Sections 25 and 26

Repeal the sections, substitute:

25  Conditions for approved pharmacists

Special arrangement supplies of certain HSD pharmaceutical benefits

(1)  The Approved Pharmacists Conditions Determination does not apply to the dispensing or supply of an HSD pharmaceutical benefit if:

(a)  the manner of administration of the benefit is injection or extracorporeal circulation; and

(b)  the benefit does not have a drug that is a community access medication; and

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

ODT pharmaceutical benefits—special arrangement supplies through agents

(2)  If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph 6(e), subsection 9(1), section 10, paragraphs 14(a) and (b) and section 15 of that Determination were omitted.

ODT pharmaceutical benefits—special arrangement supplies other than through agents

(3)  If a supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit other than a special arrangement supply of the benefit mentioned in subsection 26(2) of this instrument, the Approved Pharmacists Conditions Determination applies to the dispensing and supply of the benefit as if paragraph (c) of the definition of dispensing step in section 5 of that Determination were omitted.

26  Supplies need not be directly to persons

Supplies of HSD pharmaceutical benefits by HSD hospital authorities

(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.

Supplies of ODT pharmaceutical benefits by approved pharmacists and approved hospital authorities

(2)  An approved pharmacist or an approved hospital authority may make a special arrangement supply of an ODT pharmaceutical benefit to a person through a person or organisation:

(a)  that has premises in a State or Territory; and

(b)  that is authorised (however described) by an authority of the State or Territory for the purposes of supplying medication for the treatment of opioid dependence.

Application of this section

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

24  At the end of subsection 28(1)

Add:

Note: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

25  At the end of subsection 30(2)

Add:

Note: Section 87 of the Act limits the amounts that approved pharmacists and approved medical practitioners can charge patients for the supply of pharmaceutical benefits.

26  At the end of subsection 31(1)

Add:

Note: Section 87 of the Act limits the amounts that approved hospital authorities can charge patients for the supply of pharmaceutical benefits.

27  At the end of paragraph 32(1)(a)

Add:

and (iv)  if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee;

28  At the end of paragraph 32(1)(b)

Add:

and (iii)  if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee;

29  At the end of subsection 32(1)

Add:

and (v)  if the benefit is a ready‑prepared pharmaceutical benefit and a dangerous drug—the dangerous drug fee.

30  Subparagraph 34(1)(a)(i)

Omit “Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020 (PB 66 of 2020)”, substitute “Approved Pharmacists Commonwealth Price Determination”.

31  Subparagraph 34(1)(a)(ii)

Omit “determination”, substitute “Determination”.

32  Paragraph 34(1)(b)

Repeal the paragraph, substitute:

(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, the dispensed price for the supply of the benefit includes:

(i)  only one dispensing fee; and

(ii)  only one dangerous drug fee.

33  Subsection 35(1)

Omit “National Health (Claims and under co‑payment data) Rules 2012 (PB 19 of 2012)”, substitute “National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022”.

34  Before subsection 37(3)

Insert:

Application of this section

35  At the end of Part 6

Add:

Division 2—Provisions relating to the National Health Legislation Amendment (Opioid Dependence Treatment and Maximum Dispensed Quantities) Instrument 2023

39  Purpose of this Division

This Division makes provision in relation to certain pre‑commencement prescriptions for the purpose of the application of Part VII of the Act, and regulations and other instruments made for the purposes of that Part, to those prescriptions.

40  Definitions

In this Division:

Claims Rules means the National Health (Supply of Pharmaceutical Benefits—Under Co‑payment Data and Claims for Payment) Rules 2022.

pre‑commencement benefit: see section 50.

pre‑commencement prescription: a prescription is a pre‑commencement prescription if:

(a)  the prescription was written:

(i)  before 1 July 2023; and

(ii)  by an authorised nurse practitioner or a medical practitioner; and

(iii)  for the supply to a person of a drug that is a medication for the treatment of opioid dependence; and

(iv)  in the circumstance that the prescription was for the treatment of opiate dependence, including for detoxification (withdrawal) and maintenance of withdrawal; and

(b)  immediately before 1 July 2023, a pre‑commencement benefit could have been supplied to the person on the basis of the prescription.

41  Definition of special arrangement supply

A supply of an ODT pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:

(a)  on or after 1 July 2023; and

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

(c)  by an approved supplier; and

(d)  on the basis of a pre‑commencement prescription (as affected by this Division, if applicable); and

(e)  in accordance with this Division.

42  Prescriptions directing supply for dispensing over time

(1)  This section applies if a pre‑commencement prescription directed the supply of a specified quantity or number of units (whether expressed as a total or as a dose) to be dispensed over a specified period of time (the directed dispensing period).

Deemed variation of application of determination of maximum number or quantity of units

(2)  If the specified quantity or number of units, or the quantity or number of units required for the doses over the directed dispensing period, is more than the maximum quantity or number of units mentioned in Schedule 1 for the pharmaceutical benefit to be supplied on the basis of the prescription:

(a) the application of the determination of the maximum quantity or number of units under paragraph 85A(2)(a) of the Act for the benefit is taken to have been varied under section 30 of the Regulations; and

(b)  the prescription is taken to have been authorised in accordance with subsection 30(4) of the Regulations; and

(c)  the number P2023OD is taken to have been allotted to, and marked on, the prescription as mentioned in subsection 30(5) of the Regulations.

Deemed modification of prescription—remaining period of up to 28 days

(3)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the period remaining in the directed dispensing period (the remaining period) is not more than 28 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for the remaining period.

Deemed modification of prescription—remaining period of 29 to 55 days

(4)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 28 days but not more than 55 days, the prescription is taken to direct the supply on one occasion of the total quantity or number of units required for 28 days.

Deemed modification of prescription—remaining period of 56 to 83 days

(5)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is more than 55 days but not more than 83 days, the prescription is taken to direct:

(a)  the supply on any one occasion of the total quantity or number of units required for 28 days; and

(b)  that the supply be repeated once.

Deemed modification of prescription—remaining period of 84 days or more

(6)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining period is 84 days or more, the prescription is taken to direct:

(a)  the supply on any one occasion of the total quantity or number of units required for 28 days; and

(b)  that the supply be repeated twice.

43  Prescriptions directing supply of buprenorphine for injection

(1)  This section applies if:

(a)  a pre‑commencement prescription is for the supply of the drug buprenorphine with the manner of administration injection (the medication); and

(b)  the prescription directed the supply of a specified quantity or number of units of the medication (the directed quantity) that is more than the quantity of the medication mentioned in subsection (2) (the standard quantity for the medication).

(2)  For the purposes of paragraph (1)(b), the standard quantity for the medication is:

(a)  if the brand of the medication is Buvidal Weekly—4; or

(b)  if the brand of the medication is Buvidal Monthly or Sublocade—1.

Deemed modification of prescription—remaining quantity of not more than standard quantity

(3)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the quantity or number of units of the medication that remains to be supplied (the remaining quantity) is not more than the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the remaining quantity.

Deemed modification of prescription—remaining quantity of more than standard quantity but less than twice standard quantity

(4)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than the standard quantity for the medication but is less than twice the standard quantity for the medication, the prescription is taken to direct the supply on one occasion of the standard quantity for the medication.

Deemed modification of prescription—remaining quantity of more than twice standard quantity but less than 3 times standard quantity

(5)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is more than twice the standard quantity for the medication but is less than 3 times the standard quantity for the medication, the prescription is taken to direct:

(a)  the supply on any one occasion of the standard quantity for the medication; and

(b)  that the supply be repeated once.

Deemed modification of prescription—remaining quantity of 3 times standard quantity or more

(6)  If, when the prescription is first presented to an approved supplier on or after 1 July 2023, the remaining quantity is 3 times the standard quantity for the medication or more, the prescription is taken to direct:

(a)  the supply on any one occasion of the standard quantity for the medication; and

(b)  that the supply be repeated twice.

44  Prescriptions directing supply of methadone

(1)  This section applies if a pre‑commencement prescription is for the supply of the drug methadone.

(2)  On the basis of the prescription, the person for whom the prescription was written is entitled to receive, and an approved supplier may supply to the person, any ODT pharmaceutical benefit that has the drug methadone.

(3)  This section applies despite section 89 and paragraph 103(2)(a) of the Act.

  1. First supply on or after 1 July 2023 deemed to be supply on first presentation

If the first supply of an ODT pharmaceutical benefit by an approved supplier on the basis of a pre‑commencement prescription on or after 1 July 2023 is not a supply of that benefit on first presentation of the prescription, it is taken to be a supply of that benefit on first presentation of the prescription.

  1. Supply on first presentation of prescription (Regulations s 44)

Subparagraphs 44(2)(a)(i) and (3)(a)(i) of the Regulations do not apply to a special arrangement supply of an ODT pharmaceutical benefit on the basis of a pre‑commencement prescription.

  1. Repeat authorisations (Regulations s 52)

(1)  Section 52 of the Regulations applies to the supply of an ODT pharmaceutical benefit on the basis of a pre‑commencement prescription to which subsection 42(5) or (6) or 43(5) or (6) of this instrument applies as if the benefit were supplied in the circumstances set out in subsection 52(2) of the Regulations.

(2)  Subsection 52(3) of the Regulations applies in relation to a pre‑commencement prescription as if the prescription had been authorised in accordance with authority required procedures that are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit to be supplied on the basis of the prescription.

48  Prescriptions written in electronic form—additional procedures for giving information (Claims Rules s 7) and keeping documents

Additional procedures for giving information

(1)  Section 7 of the Claims Rules applies in relation to a pre‑commencement prescription written in electronic form as if a reference in that section to the prescription were a reference to a print‑out of the prescription.

Keeping print‑outs of prescriptions

(2)  If an approved supplier supplies a pharmaceutical benefit on the basis of a pre‑commencement prescription written in electronic form, the approved supplier must keep a print‑out of the prescription for at least 2 years from the date the pharmaceutical benefit was supplied by the approved supplier.

49  Information to be given using Claims Transmission System (Claims Rules Sch 1)

General

(1)  The table in clause 1 of Schedule 1 to the Claims Rules applies to a pre‑commencement prescription as follows:

(a)  as if, for the purposes of item 2 of the table, the Authority Prescription Number for the prescription were 00000641;

(b)  as if, for the purposes of item 8 of the table, the prescription were signed on 1 July 2023;

(c)  if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their PBS prescriber number on the prescription—as if, for the purposes of item 28 of the table, that number were written on the prescription;

(d)  if the authorised nurse practitioner or medical practitioner who wrote the prescription did not write their prescriber ID on the prescription—as if, for the purposes of item 31 of the table, that number were written on the prescription;

(e)  if the prescription was written in electronic form—as if, for the purposes of item 32 of the table, the prescription were a paper‑based prescription;

(f)  as if, for the purposes of item 40 of the table, the authorised nurse practitioner or medical practitioner who wrote the prescription had written on the prescription:

(i)  the words “Streamlined Authority Code”; and

(ii)  the relevant streamlined authority code included in any circumstances mentioned in an item of the table in Part 1 of Schedule 4 to the Listing Instrument for the writing of a prescription for a pharmaceutical benefit for the treatment of opioid dependence.

Pre‑commencement prescriptions written in electronic form

(2)  Clause 2 of Schedule 1 to the Claims Rules does not apply to a pre‑commencement prescription written in electronic form.

50  Pre‑commencement benefits

Each pharmaceutical benefit specified in the following table is a pre‑commencement benefit.

Pre‑commencement benefits
Item Listed drug Form Manner of administration Brand
1 Buprenorphine Injection (modified release) 8 mg in 0.16 mL pre‑filled syringe Injection Buvidal Weekly
2 Buprenorphine Injection (modified release) 16 mg in 0.32 mL pre‑filled syringe Injection Buvidal Weekly
3 Buprenorphine Injection (modified release) 24 mg in 0.48 mL pre‑filled syringe Injection Buvidal Weekly
4 Buprenorphine Injection (modified release) 32 mg in 0.64 mL pre‑filled syringe Injection Buvidal Weekly
5 Buprenorphine Injection (modified release) 64 mg in 0.18 mL pre‑filled syringe Injection Buvidal Monthly
6 Buprenorphine Injection (modified release) 96 mg in 0.27 mL pre‑filled syringe Injection Buvidal Monthly
7 Buprenorphine Injection (modified release) 128 mg in 0.36 mL pre‑filled syringe Injection Buvidal Monthly
8 Buprenorphine Injection (modified release) 160 mg in 0.45 mL pre‑filled syringe Injection Buvidal Monthly
9 Buprenorphine Injection (modified release) 100 mg in 0.50 mL pre‑filled syringe Injection Sublocade
10 Buprenorphine Injection (modified release) 300 mg in 1.50 mL pre‑filled syringe Injection Sublocade
11 Buprenorphine Tablet (sublingual) 400 micrograms (as hydrochloride) Sublingual Subutex
12 Buprenorphine Tablet (sublingual) 2 mg (as hydrochloride) Sublingual Subutex
13 Buprenorphine Tablet (sublingual) 8 mg (as hydrochloride) Sublingual Subutex
14 Buprenorphine with naloxone Film (soluble) 2 mg (as hydrochloride)‑0.5 mg (as hydrochloride) Sublingual Suboxone Film 2/0.5
15 Buprenorphine with naloxone Film (soluble) 8 mg (as hydrochloride)‑2 mg (as hydrochloride) Sublingual Suboxone Film 8/2
16 Methadone Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL Oral Biodone Forte
17 Methadone Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL Oral Aspen Methadone Syrup
18 Methadone Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L Oral Biodone Forte
19 Methadone Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 1 L Oral Aspen Methadone Syrup

Note: The drugs mentioned in the table were declared by the Minister under subsection 85(2) of the Act, and the forms, manners of administration and brands mentioned in the table were determined by the Minister under subsections 85(3), (5) and (6) of the Act respectively—see the Listing Instrument as in force before 1 July 2023.

Schedule 2—Maximum dispensed quantities

National Health (Listing of Pharmaceutical Benefits) Instrument 2012

  1. Schedule 1, Part 1, entry for Adapalene with benzoyl peroxide

substitute:

Adapalene with benzoyl peroxide Gel 1 mg‑25 mg per g, 30 g Application Epiduo GA MP C4898 C4961 C14133 P4961 1 1 1
MP C4898 C4961 C14133 P4898 1 3 1
NP C4898 C14133 P4898 1 3 1
MP C4898 C4961 C14133 P14133 2 3 1
NP C4898 C14133 P14133 2 3 1

  1. Schedule 1, Part 1, entry for Alendronic acid

substitute:

Alendronic acid Tablet 70 mg (as alendronate sodium) Oral a Alendronate Sandoz SZ MP NP C6310 C6323 C6327 C14027 C14028 C14089 P6310 P6323 P6327 4 5 4
a APO‑Alendronate TX MP NP C6310 C6323 C6327 C14027 C14028 C14089 P6310 P6323 P6327 4 5 4
a Fonat AL MP NP C6310 C6323 C6327 C14027 C14028 C14089 P6310 P6323 P6327 4 5 4
a Alendronate Sandoz SZ MP NP C6310 C6323 C6327 C14027 C14028 C14089 P14027 P14028 P14089 8 5 4
a APO‑Alendronate TX MP NP C6310 C6323 C6327 C14027 C14028 C14089 P14027 P14028 P14089 8 5 4
a Fonat AL MP NP C6310 C6323 C6327 C14027 C14028 C14089 P14027 P14028 P14089 8 5 4

  1. Schedule 1, Part 1, entry for Allopurinol

substitute:

Allopurinol Tablet 100 mg Oral a Allopurinol APOTEX GX MP NP 200 2 200
a Allopurinol Sandoz SZ MP NP 200 2 200
a Allosig RF MP NP 200 2 200
a NOUMED ALLOPURINOL VO MP NP 200 2 200
a Progout 100 AF MP NP 200 2 200
a Zyloprim RW MP NP 200 2 200
a Allopurinol APOTEX GX MP NP P14141 400 2 200
a Allopurinol Sandoz SZ MP NP P14141 400 2 200
a Allosig RF MP NP P14141 400 2 200
a NOUMED ALLOPURINOL VO MP NP P14141 400 2 200
a Progout 100 AF MP NP P14141 400 2 200
a Zyloprim RW MP NP P14141 400 2 200
Tablet 300 mg Oral a Allopurinol APOTEX GX MP NP 60 2 60
a Allopurinol Sandoz SZ MP NP 60 2 60
a Allosig RF MP NP 60 2 60
a NOUMED ALLOPURINOL VO MP NP 60 2 60
a Progout 300 AF MP NP 60 2 60
a Zyloprim RW MP NP 60 2 60
a Allopurinol APOTEX GX MP NP P14141 120 2 60
a Allopurinol Sandoz SZ MP NP P14141 120 2 60
a Allosig RF MP NP P14141 120 2 60
a NOUMED ALLOPURINOL VO MP NP P14141 120 2 60
a Progout 300 AF MP NP P14141 120 2 60
a Zyloprim RW MP NP P14141 120 2 60

  1. Schedule 1, Part 1, entry for Amlodipine

substitute:

Amlodipine Tablet 5 mg (as besilate) Oral a Amlo 5 RW MP NP 30 5 30
a Amlodipine Amneal EF MP NP 30 5 30
a Amlodipine APOTEX GX MP NP 30 5 30
a Amlodipine GH GQ MP NP 30 5 30
a Amlodipine Sandoz SZ MP NP 30 5 30
a APO‑Amlodipine TX MP NP 30 5 30
a Blooms Amlodipine BG MP NP 30 5 30
a Blooms the Chemist Amlodipine IB MP NP 30 5 30
a BTC Amlodipine JB MP NP 30 5 30
a Nordip AF MP NP 30 5 30
a Norvapine ED MP NP 30 5 30
a Norvasc AS MP NP 30 5 30
a NOUMED AMLODIPINE VO MP NP 30 5 30
a Pharmacor Amlodipine CR MP NP 30 5 30
a Amlo 5 RW MP NP P14141 60 5 30
a Amlodipine Amneal EF MP NP P14141 60 5 30
a Amlodipine APOTEX GX MP NP P14141 60 5 30
a Amlodipine GH GQ MP NP P14141 60 5 30
a Amlodipine Sandoz SZ MP NP P14141 60 5 30
a APO‑Amlodipine TX MP NP P14141 60 5 30
a Blooms Amlodipine BG MP NP P14141 60 5 30
a Blooms the Chemist Amlodipine IB MP NP P14141 60 5 30
a BTC Amlodipine JB MP NP P14141 60 5 30
a Nordip AF MP NP P14141 60 5 30
a Norvapine ED MP NP P14141 60 5 30
a Norvasc AS MP NP P14141 60 5 30
a NOUMED AMLODIPINE VO MP NP P14141 60 5 30
a Pharmacor Amlodipine CR MP NP P14141 60 5 30
Tablet 10 mg (as besilate) Oral a Amlo 10 RW MP NP 30 5 30
a Amlodipine Amneal EF MP NP 30 5 30
a Amlodipine APOTEX GX MP NP 30 5 30
a Amlodipine GH GQ MP NP 30 5 30
a Amlodipine Sandoz SZ MP NP 30 5 30
a APO‑Amlodipine TX MP NP 30 5 30
a Blooms Amlodipine BG MP NP 30 5 30
a Blooms the Chemist Amlodipine IB MP NP 30 5 30
a BTC Amlodipine JB MP NP 30 5 30
a Nordip AF MP NP 30 5 30
a Norvapine ED MP NP 30 5 30
a Norvasc AS MP NP 30 5 30
a NOUMED AMLODIPINE VO MP NP 30 5 30
a Pharmacor Amlodipine CR MP NP 30 5 30
a Amlo 10 RW MP NP P14141 60 5 30
a Amlodipine Amneal EF MP NP P14141 60 5 30
a Amlodipine APOTEX GX MP NP P14141 60 5 30
a Amlodipine GH GQ MP NP P14141 60 5 30
a Amlodipine Sandoz SZ MP NP P14141 60 5 30
a APO‑Amlodipine TX MP NP P14141 60 5 30
a Blooms Amlodipine BG MP NP P14141 60 5 30
a Blooms the Chemist Amlodipine IB MP NP P14141 60 5 30
a BTC Amlodipine JB MP NP P14141 60 5 30
a Nordip AF MP NP P14141 60 5 30
a Norvapine ED MP NP P14141 60 5 30
a Norvasc AS MP NP P14141 60 5 30
a NOUMED AMLODIPINE VO MP NP P14141 60 5 30
a Pharmacor Amlodipine CR MP NP P14141 60 5 30

  1. Schedule 1, Part 1, entry for Amlodipine with atorvastatin

substitute:

Amlodipine with atorvastatin Tablet 5 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) Oral Cadivast 5/10 AF MP NP 30 5 30
MP NP P14141 60 5 30
Tablet 5 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) Oral Cadivast 5/20 AF MP NP 30 5 30
MP NP P14141 60 5 30
Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) Oral a Cadivast 5/40 AF MP NP 30 5 30
a Caduet 5/40 AS MP NP 30 5 30
a Cadivast 5/40 AF MP NP P14141 60 5 30
a Caduet 5/40 AS MP NP P14141 60 5 30
Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) Oral a Cadivast 5/80 AF MP NP 30 5 30
a Caduet 5/80 AS MP NP 30 5 30
a Cadivast 5/80 AF MP NP P14141 60 5 30
a Caduet 5/80 AS MP NP P14141 60 5 30
Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium) Oral a Cadivast 10/10 AF MP NP 30 5 30
a Caduet 10/10 AS MP NP 30 5 30
a Cadivast 10/10 AF MP NP P14141 60 5 30
a Caduet 10/10 AS MP NP P14141 60 5 30
Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium) Oral a Cadivast 10/20 AF MP NP 30 5 30
a Caduet 10/20 AS MP NP 30 5 30
a Cadivast 10/20 AF MP NP P14141 60 5 30
a Caduet 10/20 AS MP NP P14141 60 5 30
Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium) Oral a Cadivast 10/40 AF MP NP 30 5 30
a Caduet 10/40 AS MP NP 30 5 30
a Cadivast 10/40 AF MP NP P14141 60 5 30
a Caduet 10/40 AS MP NP P14141 60 5 30
Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium) Oral a Cadivast 10/80 AF MP NP 30 5 30
a Caduet 10/80 AS MP NP 30 5 30
a Cadivast 10/80 AF MP NP P14141 60 5 30
a Caduet 10/80 AS MP NP P14141 60 5 30

  1. Schedule 1, Part 1, entry for Amlodipine with valsartan

substitute:

Amlodipine with valsartan Tablet 5 mg (as besilate)‑80 mg Oral a Exforge 5/80 NV MP NP C4373 C14043 P4373 28 5 28
a Valsartan/Amlodipine Novartis 80/5 NM MP NP C4373 C14043 P4373 28 5 28
a Exforge 5/80 NV MP NP C4373 C14043 P14043 56 5 28
a Valsartan/Amlodipine Novartis 80/5 NM MP NP C4373 C14043 P14043 56 5 28
Tablet 5 mg (as besilate)‑160 mg Oral a Exforge 5/160 NV MP NP C4373 C14043 P4373 28 5 28
a Valsartan/Amlodipine Novartis 160/5 NM MP NP C4373 C14043 P4373 28 5 28
a Exforge 5/160 NV MP NP C4373 C14043 P14043 56 5 28
a Valsartan/Amlodipine Novartis 160/5 NM MP NP C4373 C14043 P14043 56 5 28
Tablet 5 mg (as besilate)‑320 mg Oral a Exforge 5/320 NV MP NP C4373 C14043 P4373 28 5 28
a Valsartan/Amlodipine Novartis 320/5 NM MP NP C4373 C14043 P4373 28 5 28
a Exforge 5/320 NV MP NP C4373 C14043 P14043 56 5 28
a Valsartan/Amlodipine Novartis 320/5 NM MP NP C4373 C14043 P14043 56 5 28
Tablet 10 mg (as besilate)‑160 mg Oral a Exforge 10/160 NV MP NP C4373 C14043 P4373 28 5 28
a Valsartan/Amlodipine Novartis 160/10 NM MP NP C4373 C14043 P4373 28 5 28
a Exforge 10/160 NV MP NP C4373 C14043 P14043 56 5 28
a Valsartan/Amlodipine Novartis 160/10 NM MP NP C4373 C14043 P14043 56 5 28
Tablet 10 mg (as besilate)‑320 mg Oral a Exforge 10/320 NV MP NP C4373 C14043 P4373 28 5 28
a Valsartan/Amlodipine Novartis 320/10 NM MP NP C4373 C14043 P4373 28 5 28
a Exforge 10/320 NV MP NP C4373 C14043 P14043 56 5 28
a Valsartan/Amlodipine Novartis 320/10 NM MP NP C4373 C14043 P14043 56 5 28

[7]          Schedule 1, Part 1, entry for Amlodipine with valsartan and hydrochlorothiazide

substitute:

Amlodipine with valsartan and hydrochlorothiazide Tablet 5 mg (as besilate)‑160 mg‑12.5 mg Oral a Exforge HCT 5/160/12.5 NV MP NP C4311 C14062 P4311 28 5 28
a Valsartan/Amlodipine/HCT Novartis 160/5/12.5 NM MP NP C4311 C14062 P4311 28 5 28
a Exforge HCT 5/160/12.5 NV MP NP C4311 C14062 P14062 56 5 28
a Valsartan/Amlodipine/HCT Novartis 160/5/12.5 NM MP NP C4311 C14062 P14062 56 5 28
Tablet 5 mg (as besilate)‑160 mg‑25 mg Oral a Exforge HCT 5/160/25 NV MP NP C4311 C14062 P4311 28 5 28
a Valsartan/Amlodipine/HCT Novartis 160/5/25 NM MP NP C4311 C14062 P4311 28 5 28
a Exforge HCT 5/160/25 NV MP NP C4311 C14062 P14062 56 5 28
a Valsartan/Amlodipine/HCT Novartis 160/5/25 NM MP NP C4311 C14062 P14062 56 5 28
Tablet 10 mg (as besilate)‑160 mg‑12.5 mg Oral a Exforge HCT 10/160/12.5 NV MP NP C4311 C14062 P4311 28 5 28
a Valsartan/Amlodipine/HCT Novartis 160/10/12.5 NM MP NP C4311 C14062 P4311 28 5 28
a Exforge HCT 10/160/12.5 NV MP NP C4311 C14062 P14062 56 5 28
a Valsartan/Amlodipine/HCT Novartis 160/10/12.5 NM MP NP C4311 C14062 P14062 56 5 28
Tablet 10 mg (as besilate)‑160 mg‑25 mg Oral a Exforge HCT 10/160/25 NV MP NP C4311 C14062 P4311 28 5 28
a Valsartan/Amlodipine/HCT Novartis 160/10/25 NM MP NP C4311 C14062 P4311 28 5 28
a Exforge HCT 10/160/25 NV MP NP C4311 C14062 P14062 56 5 28
a Valsartan/Amlodipine/HCT Novartis 160/10/25 NM MP NP C4311 C14062 P14062 56 5 28
Tablet 10 mg (as besilate)‑320 mg‑25 mg Oral a Exforge HCT 10/320/25 NV MP NP C4311 C14062 P4311 28 5 28
a Valsartan/Amlodipine/HCT Novartis 320/10/25 NM MP NP C4311 C14062 P4311 28 5 28
a Exforge HCT 10/320/25 NV MP NP C4311 C14062 P14062 56 5 28
a Valsartan/Amlodipine/HCT Novartis 320/10/25 NM MP NP C4311 C14062 P14062 56 5 28

  1. Schedule 1, Part 1, entry for Apixaban

substitute:

Apixaban Tablet 2.5 mg Oral Eliquis BQ MP NP C4132 C4269 C4359 C4381 C4382 C4402 C4409 C14078 C14139 P4359 P4381 20 0 20
MP NP C4132 C4269 C4359 C4381 C4382 C4402 C4409 C14078 C14139 P4382 P4409 30 0 30
MP NP C4132 C4269 C4359 C4381 C4382 C4402 C4409 C14078 C14139 P4402 60 0 60
MP NP C4132 C4269 C4359 C4381 C4382 C4402 C4409 C14078 C14139 P4132 P4269 60 5 60
MP NP C4132 C4269 C4359 C4381 C4382 C4402 C4409 C14078 C14139 P14078 P14139 120 5 60
Tablet 5 mg Oral Eliquis BQ MP NP C4098 C4099 C4269 C5083 C5098 C14078 C14095 C14129 P4098 P5098 28 0 28
MP NP C4098 C4099 C4269 C5083 C5098 C14078 C14095 C14129 P4099 P4269 P5083 60 5 60
MP NP C4098 C4099 C4269 C5083 C5098 C14078 C14095 C14129 P14078 P14095 P14129 120 5 60

  1. Schedule 1, Part 1, entry for Atenolol

substitute:

Atenolol Oral solution 50 mg in 10 mL, 300 mL Oral Atenolol‑AFT AE MP NP C4076 C14039 P4076 1 5 1
MP NP C4076 C14039 P14039 2 5 1
Tablet 50 mg Oral a APO‑Atenolol TX MP NP 30 5 30
a APX‑Atenolol TY MP NP 30 5 30
a Atenolol Amneal EF MP NP 30 5 30
a Atenolol GH GQ MP NP 30 5 30
a Atenolol Sandoz SZ MP NP 30 5 30
a Noten AF MP NP 30 5 30
a Tenormin IX MP NP 30 5 30
a Tensig RW MP NP 30 5 30
a APO‑Atenolol TX MP NP P14141 60 5 30
a APX‑Atenolol TY MP NP P14141 60 5 30
a Atenolol Amneal EF MP NP P14141 60 5 30
a Atenolol GH GQ MP NP P14141 60 5 30
a Atenolol Sandoz SZ MP NP P14141 60 5 30
a Noten AF MP NP P14141 60 5 30
a Tenormin IX MP NP P14141 60 5 30
a Tensig RW MP NP P14141 60 5 30

  1. Schedule 1, Part 1, entry for Atorvastatin

substitute:

Atorvastatin Tablet 10 mg (as calcium) Oral a APO‑Atorvastatin TX MP NP 30 5 30
a Atorvachol RF MP NP 30 5 30
a Atorvastatin GH GQ MP NP 30 5 30
a Atorvastatin SZ HX MP NP 30 5 30
a Blooms the Chemist Atorvastatin IB MP NP 30 5 30
a Lipitor AS MP NP 30 5 30
a Lorstat 10 AF MP NP 30 5 30
a NOUMED ATORVASTATIN VO MP NP 30 5 30
a Pharmacor Atorvastatin CR MP NP 30 5 30
a Trovas RA MP NP 30 5 30
a APO‑Atorvastatin TX MP P7598 30 11 30
a Atorvachol RF MP P7598 30 11 30
a Atorvastatin GH GQ MP P7598 30 11 30
a Atorvastatin SZ HX MP P7598 30 11 30
a Blooms the Chemist Atorvastatin IB MP P7598 30 11 30
a Lipitor AS MP P7598 30 11 30
a Lorstat 10 AF MP P7598 30 11 30
a NOUMED ATORVASTATIN VO MP P7598 30 11 30
a Pharmacor Atorvastatin CR MP P7598 30 11 30
a Trovas RA MP P7598 30 11 30
a APO‑Atorvastatin TX MP P14141 60 5 30
a Atorvachol RF MP P14141 60 5 30
a Atorvastatin GH GQ MP P14141 60 5 30
a Atorvastatin SZ HX MP P14141 60 5 30
a Blooms the Chemist Atorvastatin IB MP P14141 60 5 30
a Lipitor AS MP P14141 60 5 30
a Lorstat 10 AF MP P14141 60 5 30
a NOUMED ATORVASTATIN VO MP P14141 60 5 30
a Pharmacor Atorvastatin CR MP P14141 60 5 30
a Trovas RA MP P14141 60 5 30
Tablet 20 mg (as calcium) Oral a APO‑Atorvastatin TX MP NP 30 5 30
a Atorvachol RF MP NP 30 5 30
a Atorvastatin GH GQ MP NP 30 5 30
a Atorvastatin SZ HX MP NP 30 5 30
a Blooms the Chemist Atorvastatin IB MP NP 30 5 30
a Lipitor AS MP NP 30 5 30
a Lorstat 20 AF MP NP 30 5 30
a NOUMED ATORVASTATIN VO MP NP 30 5 30
a Pharmacor Atorvastatin CR MP NP 30 5 30
a Trovas RA MP NP 30 5 30
a APO‑Atorvastatin TX MP P7598 30 11 30
a Atorvachol RF MP P7598 30 11 30
a Atorvastatin GH GQ MP P7598 30 11 30
a Atorvastatin SZ HX MP P7598 30 11 30
a Blooms the Chemist Atorvastatin IB MP P7598 30 11 30
a Lipitor AS MP P7598 30 11 30
a Lorstat 20 AF MP P7598 30 11 30
a NOUMED ATORVASTATIN VO MP P7598 30 11 30
a Pharmacor Atorvastatin CR MP P7598 30 11 30
a Trovas RA MP P7598 30 11 30
a APO‑Atorvastatin TX MP P14141 60 5 30
a Atorvachol RF MP P14141 60 5 30
a Atorvastatin GH GQ MP P14141 60 5 30
a Atorvastatin SZ HX MP P14141 60 5 30
a Blooms the Chemist Atorvastatin IB MP P14141 60 5 30
a Lipitor AS MP P14141 60 5 30
a Lorstat 20 AF MP P14141 60 5 30
a NOUMED ATORVASTATIN VO MP P14141 60 5 30
a Pharmacor Atorvastatin CR MP P14141 60 5 30
a Trovas RA MP P14141 60 5 30
Tablet 40 mg (as calcium) Oral a APO‑Atorvastatin TX MP NP 30 5 30
a Atorvachol RF MP NP 30 5 30
a Atorvastatin GH GQ MP NP 30 5 30
a Atorvastatin SZ HX MP NP 30 5 30
a Blooms the Chemist Atorvastatin IB MP NP 30 5 30
a Lipitor AS MP NP 30 5 30
a Lorstat 40 AF MP NP 30 5 30
a NOUMED ATORVASTATIN VO MP NP 30 5 30
a Pharmacor Atorvastatin CR MP NP 30 5 30
a Trovas RA MP NP 30 5 30
a APO‑Atorvastatin TX MP P7598 30 11 30
a Atorvachol RF MP P7598 30 11 30
a Atorvastatin GH GQ MP P7598 30 11 30
a Atorvastatin SZ HX MP P7598 30 11 30
a Blooms the Chemist Atorvastatin IB MP P7598 30 11 30
a Lipitor AS MP P7598 30 11 30
a Lorstat 40 AF MP P7598 30 11 30
a NOUMED ATORVASTATIN VO MP P7598 30 11 30
a Pharmacor Atorvastatin CR MP P7598 30 11 30
a Trovas RA MP P7598 30 11 30
a APO‑Atorvastatin TX MP P14141 60 5 30
a Atorvachol RF MP P14141 60 5 30
a Atorvastatin GH GQ MP P14141 60 5 30
a Atorvastatin SZ HX MP P14141 60 5 30
a Blooms the Chemist Atorvastatin IB MP P14141 60 5 30
a Lipitor AS MP P14141 60 5 30
a Lorstat 40 AF MP P14141 60 5 30
a NOUMED ATORVASTATIN VO MP P14141 60 5 30
a Pharmacor Atorvastatin CR MP P14141 60 5 30
a Trovas RA MP P14141 60 5 30
Tablet 80 mg (as calcium) Oral a APO‑Atorvastatin TX MP NP 30 5 30
a Atorvachol RF MP NP 30 5 30
a Atorvastatin GH GQ MP NP 30 5 30
a Atorvastatin SZ HX MP NP 30 5 30
a Blooms the Chemist Atorvastatin IB MP NP 30 5 30
a Lipitor AS MP NP 30 5 30
a Lorstat 80 AF MP NP 30 5 30
a NOUMED ATORVASTATIN VO MP NP 30 5 30
a Pharmacor Atorvastatin CR MP NP 30 5 30
a Trovas RA MP NP 30 5 30
a APO‑Atorvastatin TX MP P7598 30 11 30
a Atorvachol RF MP P7598 30 11 30
a Atorvastatin GH GQ MP P7598 30 11 30
a Atorvastatin SZ HX MP P7598 30 11 30
a Blooms the Chemist Atorvastatin IB MP P7598 30 11 30
a Lipitor AS MP P7598 30 11 30
a Lorstat 80 AF MP P7598 30 11 30
a NOUMED ATORVASTATIN VO MP P7598 30 11 30
a Pharmacor Atorvastatin CR MP P7598 30 11 30
a Trovas RA MP P7598 30 11 30
a APO‑Atorvastatin TX MP P14141 60 5 30
a Atorvachol RF MP P14141 60 5 30
a Atorvastatin GH GQ MP P14141 60 5 30
a Atorvastatin SZ HX MP P14141 60 5 30
a Blooms the Chemist Atorvastatin IB MP P14141 60 5 30
a Lipitor AS MP P14141 60 5 30
a Lorstat 80 AF MP P14141 60 5 30
a NOUMED ATORVASTATIN VO MP P14141 60 5 30
a Pharmacor Atorvastatin CR MP P14141 60 5 30
a Trovas RA MP P14141 60 5 30

  1. Schedule 1, Part 1, entry for Baclofen in the form Tablet 10 mg

substitute:

Tablet 10 mg Oral a APO‑Baclofen TX MP NP 100 5 100
a Clofen 10 AF MP NP 100 5 100
a Lioresal 10 NV MP NP 100 5 100
a Stelax 10 RW MP NP 100 5 100
a APO‑Baclofen TX MP NP P14141 200 5 100
a Clofen 10 AF MP NP P14141 200 5 100
a Lioresal 10 NV MP NP P14141 200 5 100
a Stelax 10 RW MP NP P14141 200 5 100

  1. Schedule 1, Part 1, entry for Baclofen in the form Tablet 25 mg

substitute:

Tablet 25 mg Oral a APO‑Baclofen TX MP NP 100 5 100
a Clofen 25 AF MP NP 100 5 100
a Lioresal 25 NV MP NP 100 5 100
a Stelax 25 RW MP NP 100 5 100
a APO‑Baclofen TX MP NP P14141 200 5 100
a Clofen 25 AF MP NP P14141 200 5 100
a Lioresal 25 NV MP NP P14141 200 5 100
a Stelax 25 RW MP NP P14141 200 5 100

  1. Schedule 1, Part 1, entry for Balsalazide

substitute:

Balsalazide Capsule containing balsalazide sodium 750 mg Oral Colazide PK MP NP C7621 C14084 P7621 280 5 280
MP NP C7621 C14084 P14084 560 5 280

  1. Schedule 1, Part 1, entry for Bisoprolol

substitute:

Bisoprolol Tablet containing bisoprolol fumarate 2.5 mg Oral a APO‑Bisoprolol TX MP NP C5324 C14033 P5324 28 5 28
a Bicard 2.5 RW MP NP C5324 C14033 P5324 28 5 28
a Bicor AL MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol Dr.Reddy's RI MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol generichealth GQ MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol Sandoz SZ MP NP C5324 C14033 P5324 28 5 28
a Bispro 2.5 AF MP NP C5324 C14033 P5324 28 5 28
a Cipla Bisoprolol LR MP NP C5324 C14033 P5324 28 5 28
a NOUMED BISOPROLOL VO MP NP C5324 C14033 P5324 28 5 28
a APO‑Bisoprolol TX MP NP C5324 C14033 P14033 56 5 28
a Bicard 2.5 RW MP NP C5324 C14033 P14033 56 5 28
a Bicor AL MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol Dr.Reddy's RI MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol generichealth GQ MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol Sandoz SZ MP NP C5324 C14033 P14033 56 5 28
a Bispro 2.5 AF MP NP C5324 C14033 P14033 56 5 28
a Cipla Bisoprolol LR MP NP C5324 C14033 P14033 56 5 28
a NOUMED BISOPROLOL VO MP NP C5324 C14033 P14033 56 5 28
Tablet containing bisoprolol fumarate 5 mg Oral a APO‑Bisoprolol TX MP NP C5324 C14033 P5324 28 5 28
a Bicard 5 RW MP NP C5324 C14033 P5324 28 5 28
a Bicor AL MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol Dr.Reddy's RI MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol generichealth GQ MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol Sandoz SZ MP NP C5324 C14033 P5324 28 5 28
a Bispro 5 AF MP NP C5324 C14033 P5324 28 5 28
a Cipla Bisoprolol LR MP NP C5324 C14033 P5324 28 5 28
a NOUMED BISOPROLOL VO MP NP C5324 C14033 P5324 28 5 28
a APO‑Bisoprolol TX MP NP C5324 C14033 P14033 56 5 28
a Bicard 5 RW MP NP C5324 C14033 P14033 56 5 28
a Bicor AL MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol Dr.Reddy's RI MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol generichealth GQ MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol Sandoz SZ MP NP C5324 C14033 P14033 56 5 28
a Bispro 5 AF MP NP C5324 C14033 P14033 56 5 28
a Cipla Bisoprolol LR MP NP C5324 C14033 P14033 56 5 28
a NOUMED BISOPROLOL VO MP NP C5324 C14033 P14033 56 5 28
Tablet containing bisoprolol fumarate 10 mg Oral a APO‑Bisoprolol TX MP NP C5324 C14033 P5324 28 5 28
a Bicard 10 RW MP NP C5324 C14033 P5324 28 5 28
a Bicor AL MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol Dr.Reddy's RI MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol generichealth GQ MP NP C5324 C14033 P5324 28 5 28
a Bisoprolol Sandoz SZ MP NP C5324 C14033 P5324 28 5 28
a Bispro 10 AF MP NP C5324 C14033 P5324 28 5 28
a Cipla Bisoprolol LR MP NP C5324 C14033 P5324 28 5 28
a NOUMED BISOPROLOL VO MP NP C5324 C14033 P5324 28 5 28
a APO‑Bisoprolol TX MP NP C5324 C14033 P14033 56 5 28
a Bicard 10 RW MP NP C5324 C14033 P14033 56 5 28
a Bicor AL MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol Dr.Reddy's RI MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol generichealth GQ MP NP C5324 C14033 P14033 56 5 28
a Bisoprolol Sandoz SZ MP NP C5324 C14033 P14033 56 5 28
a Bispro 10 AF MP NP C5324 C14033 P14033 56 5 28
a Cipla Bisoprolol LR MP NP C5324 C14033 P14033 56 5 28
a NOUMED BISOPROLOL VO MP NP C5324 C14033 P14033 56 5 28

  1. Schedule 1, Part 1, entry for Calcipotriol with betamethasone

substitute:

Calcipotriol with betamethasone Foam containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g Application Enstilar LO MP NP C6809 C14091 P6809 1 1 1
MP NP C6809 C14091 P14091 2 1 1
Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g Application a Calcipotriol/Betamethasone Sandoz 50/500 SZ MP NP C6809 C14091 P6809 1 1 1
a Daivobet LO MP NP C6809 C14091 P6809 1 1 1
a Calcipotriol/Betamethasone Sandoz 50/500 SZ MP NP C6809 C14091 P14091 2 1 1
a Daivobet LO MP NP C6809 C14091 P14091 2 1 1

  1. Schedule 1, Part 1, entry for Calcitriol

substitute:

Calcitriol Capsule 0.25 microgram Oral a APO‑Calcitriol TX MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P5089 P5114 P5255 P5401 P5402 100 3 100
a Calciprox ZS MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P5089 P5114 P5255 P5401 P5402 100 3 100
a Calcitriol AN EA MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P5089 P5114 P5255 P5401 P5402 100 3 100
a CALITROL ED MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P5089 P5114 P5255 P5401 P5402 100 3 100
a Kosteo RW MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P5089 P5114 P5255 P5401 P5402 100 3 100
a Rocaltrol IX MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P5089 P5114 P5255 P5401 P5402 100 3 100
a Sical AF MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P5089 P5114 P5255 P5401 P5402 100 3 100
a APO‑Calcitriol TX MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P14071 P14087 P14088 P14100 P14111 200 3 100
a Calciprox ZS MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P14071 P14087 P14088 P14100 P14111 200 3 100
a Calcitriol AN EA MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P14071 P14087 P14088 P14100 P14111 200 3 100
a CALITROL ED MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P14071 P14087 P14088 P14100 P14111 200 3 100
a Kosteo RW MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P14071 P14087 P14088 P14100 P14111 200 3 100
a Rocaltrol IX MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P14071 P14087 P14088 P14100 P14111 200 3 100
a Sical AF MP NP C5089 C5114 C5255 C5401 C5402 C14071 C14087 C14088 C14100 C14111 P14071 P14087 P14088 P14100 P14111 200 3 100

  1. Schedule 1, Part 1, entry for Calcium

substitute:

Calcium Tablet, chewable, 500 mg (as carbonate) Oral Cal‑500 PP MP NP C4586 C14054 P4586 240 1 120
MP NP C4586 C14054 P14054 480 1 120
Tablet 600 mg (as carbonate) Oral Calci‑Tab 600 AE MP NP C4586 C14054 P4586 240 1 240
MP NP C4586 C14054 P14054 480 1 240

  1. Schedule 1, Part 1, entry for Candesartan

substitute:

Candesartan Tablet containing candesartan cilexetil 4 mg Oral a Adesan AF MP NP 30 5 30
a APO‑Candesartan TX MP NP 30 5 30
a Atacand AP MP NP 30 5 30
a Blooms the Chemist Candesartan IB MP NP 30 5 30
a BTC Candesartan BG MP NP 30 5 30
a CANDESAN RF MP NP 30 5 30
a Candesartan Sandoz SZ MP NP 30 5 30
a NOUMED CANDESARTAN VO MP NP 30 5 30
a Adesan AF MP NP P14141 60 5 30
a APO‑Candesartan TX MP NP P14141 60 5 30
a Atacand AP MP NP P14141 60 5 30
a Blooms the Chemist Candesartan IB MP NP P14141 60 5 30
a BTC Candesartan BG MP NP P14141 60 5 30
a CANDESAN RF MP NP P14141 60 5 30
a Candesartan Sandoz SZ MP NP P14141 60 5 30
a NOUMED CANDESARTAN VO MP NP P14141 60 5 30
Tablet containing candesartan cilexetil 8 mg Oral a Adesan AF MP NP 30 5 30
a APO‑Candesartan TX MP NP 30 5 30
a Atacand AP MP NP 30 5 30
a Blooms the Chemist Candesartan IB MP NP 30 5 30
a BTC Candesartan BG MP NP 30 5 30
a CANDESAN RF MP NP 30 5 30
a Candesartan Sandoz SZ MP NP 30 5 30
a NOUMED CANDESARTAN VO MP NP 30 5 30
a Adesan AF MP NP P14141 60 5 30
a APO‑Candesartan TX MP NP P14141 60 5 30
a Atacand AP MP NP P14141 60 5 30
a Blooms the Chemist Candesartan IB MP NP P14141 60 5 30
a BTC Candesartan BG MP NP P14141 60 5 30
a CANDESAN RF MP NP P14141 60 5 30
a Candesartan Sandoz SZ MP NP P14141 60 5 30
a NOUMED CANDESARTAN VO MP NP P14141 60 5 30
Tablet containing candesartan cilexetil 16 mg Oral a Adesan AF MP NP 30 5 30
a APO‑Candesartan TX MP NP 30 5 30
a Atacand AP MP NP 30 5 30
a Blooms the Chemist Candesartan IB MP NP 30 5 30
a BTC Candesartan BG MP NP 30 5 30
a CANDESAN RF MP NP 30 5 30
a Candesartan Sandoz SZ MP NP 30 5 30
a NOUMED CANDESARTAN VO MP NP 30 5 30
a Adesan AF MP NP P14141 60 5 30
a APO‑Candesartan TX MP NP P14141 60 5 30
a Atacand AP MP NP P14141 60 5 30
a Blooms the Chemist Candesartan IB MP NP P14141 60 5 30
a BTC Candesartan BG MP NP P14141 60 5 30
a CANDESAN RF MP NP P14141 60 5 30
a Candesartan Sandoz SZ MP NP P14141 60 5 30
a NOUMED CANDESARTAN VO MP NP P14141 60 5 30
Tablet containing candesartan cilexetil 32 mg Oral a Adesan AF MP NP 30 5 30
a APO‑Candesartan TX MP NP 30 5 30
a Atacand AP MP NP 30 5 30
a Blooms the Chemist Candesartan IB MP NP 30 5 30
a BTC Candesartan BG MP NP 30 5 30
a CANDESAN RF MP NP 30 5 30
a Candesartan Sandoz SZ MP NP 30 5 30
a NOUMED CANDESARTAN VO MP NP 30 5 30
a Adesan AF MP NP P14141 60 5 30
a APO‑Candesartan TX MP NP P14141 60 5 30
a Atacand AP MP NP P14141 60 5 30
a Blooms the Chemist Candesartan IB MP NP P14141 60 5 30
a BTC Candesartan BG MP NP P14141 60 5 30
a CANDESAN RF MP NP P14141 60 5 30
a Candesartan Sandoz SZ MP NP P14141 60 5 30
a NOUMED CANDESARTAN VO MP NP P14141 60 5 30

  1. Schedule 1, Part 1, entry for Candesartan with hydrochlorothiazide

substitute:

Candesartan with hydrochlorothiazide Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg Oral a Adesan HCT 16/12.5 AF MP NP C4374 C14061 P4374 30 5 30
a APO‑Candesartan HCTZ 16/12.5 TX MP NP C4374 C14061 P4374 30 5 30
a Atacand Plus 16/12.5 AP MP NP C4374 C14061 P4374 30 5 30
a Blooms the Chemist Candesartan HCTZ 16/12.5 IB MP NP C4374 C14061 P4374 30 5 30
a CANDESAN COMBI 16/12.5 RF MP NP C4374 C14061 P4374 30 5 30
a Candesartan/HCT Sandoz SZ MP NP C4374 C14061 P4374 30 5 30
a NOUMED CANDESARTAN/HCT VO MP NP C4374 C14061 P4374 30 5 30
a Adesan HCT 16/12.5 AF MP NP C4374 C14061 P14061 60 5 30
a APO‑Candesartan HCTZ 16/12.5 TX MP NP C4374 C14061 P14061 60 5 30
a Atacand Plus 16/12.5 AP MP NP C4374 C14061 P14061 60 5 30
a Blooms the Chemist Candesartan HCTZ 16/12.5 IB MP NP C4374 C14061 P14061 60 5 30
a CANDESAN COMBI 16/12.5 RF MP NP C4374 C14061 P14061 60 5 30
a Candesartan/HCT Sandoz SZ MP NP C4374 C14061 P14061 60 5 30
a NOUMED CANDESARTAN/HCT VO MP NP C4374 C14061 P14061 60 5 30
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg Oral a Adesan HCT 32/12.5 AF MP NP C4374 C14061 P4374 30 5 30
a APO‑Candesartan HCTZ 32/12.5 TX MP NP C4374 C14061 P4374 30 5 30
a Atacand Plus 32/12.5 AP MP NP C4374 C14061 P4374 30 5 30
a Blooms the Chemist Candesartan HCTZ 32/12.5 IB MP NP C4374 C14061 P4374 30 5 30
a CANDESAN COMBI 32/12.5 RF MP NP C4374 C14061 P4374 30 5 30
a Candesartan/HCT Sandoz SZ MP NP C4374 C14061 P4374 30 5 30
a NOUMED CANDESARTAN/HCT VO MP NP C4374 C14061 P4374 30 5 30
a Adesan HCT 32/12.5 AF MP NP C4374 C14061 P14061 60 5 30
a APO‑Candesartan HCTZ 32/12.5 TX MP NP C4374 C14061 P14061 60 5 30
a Atacand Plus 32/12.5 AP MP NP C4374 C14061 P14061 60 5 30
a Blooms the Chemist Candesartan HCTZ 32/12.5 IB MP NP C4374 C14061 P14061 60 5 30
a CANDESAN COMBI 32/12.5 RF MP NP C4374 C14061 P14061 60 5 30
a Candesartan/HCT Sandoz SZ MP NP C4374 C14061 P14061 60 5 30
a NOUMED CANDESARTAN/HCT VO MP NP C4374 C14061 P14061 60 5 30
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg Oral a Adesan HCT 32/25 AF MP NP C4374 C14061 P4374 30 5 30
a APO‑Candesartan HCTZ 32/25 TX MP NP C4374 C14061 P4374 30 5 30
a Atacand Plus 32/25 AP MP NP C4374 C14061 P4374 30 5 30
a Blooms the Chemist Candesartan HCTZ 32/25 IB MP NP C4374 C14061 P4374 30 5 30
a CANDESAN COMBI 32/25 RF MP NP C4374 C14061 P4374 30 5 30
a Candesartan/HCT Sandoz SZ MP NP C4374 C14061 P4374 30 5 30
a NOUMED CANDESARTAN/HCT VO MP NP C4374 C14061 P4374 30 5 30
a Adesan HCT 32/25 AF MP NP C4374 C14061 P14061 60 5 30
a APO‑Candesartan HCTZ 32/25 TX MP NP C4374 C14061 P14061 60 5 30
a Atacand Plus 32/25 AP MP NP C4374 C14061 P14061 60 5 30
a Blooms the Chemist Candesartan HCTZ 32/25 IB MP NP C4374 C14061 P14061 60 5 30
a CANDESAN COMBI 32/25 RF MP NP C4374 C14061 P14061 60 5 30
a Candesartan/HCT Sandoz SZ MP NP C4374 C14061 P14061 60 5 30
a NOUMED CANDESARTAN/HCT VO MP NP C4374 C14061 P14061 60 5 30

  1. Schedule 1, Part 1, entry for Carvedilol in the form Tablet 6.25 mg

substitute:

Tablet 6.25 mg Oral a APO‑Carvedilol TX MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Carvedilol Sandoz SZ MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Carvidol RF MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Dicarz AF MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Dilatrend 6.25 PB MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Vedilol 6.25 RW MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Volirop 6.25 ZS MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a APO‑Carvedilol TX MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Carvedilol Sandoz SZ MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Carvidol RF MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Dicarz AF MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Dilatrend 6.25 PB MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Vedilol 6.25 RW MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Volirop 6.25 ZS MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60

  1. Schedule 1, Part 1, entry for Carvedilol in the form Tablet 12.5 mg

substitute:

Tablet 12.5 mg Oral a APO‑Carvedilol TX MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Carvedilol Sandoz SZ MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Carvidol RF MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Dicarz AF MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Dilatrend 12.5 PB MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Vedilol 12.5 RW MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Volirop 12.5 ZS MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a APO‑Carvedilol TX MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Carvedilol Sandoz SZ MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Carvidol RF MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Dicarz AF MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Dilatrend 12.5 PB MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Vedilol 12.5 RW MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Volirop 12.5 ZS MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60

  1. Schedule 1, Part 1, entry for Carvedilol in the form Tablet 25 mg

substitute:

Tablet 25 mg Oral a APO‑Carvedilol TX MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Carvedilol Sandoz SZ MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Carvidol RF MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Dicarz AF MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Dilatrend 25 PB MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Vedilol 25 RW MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a Volirop 25 ZS MP NP C5324 C5394 C14033 C14115 P5324 P5394 60 5 60
a APO‑Carvedilol TX MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Carvedilol Sandoz SZ MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Carvidol RF MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Dicarz AF MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Dilatrend 25 PB MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Vedilol 25 RW MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60
a Volirop 25 ZS MP NP C5324 C5394 C14033 C14115 P14033 P14115 120 5 60

  1. Schedule 1, Part 1, entry for Chlortalidone

substitute:

Chlortalidone Tablet 25 mg Oral Hygroton 25 GH MP NP 100 1 50
MP NP P14141 200 1 50

  1. Schedule 1, Part 1, entry for Clonidine

substitute:

Clonidine Tablet containing clonidine hydrochloride 100 micrograms Oral a APO‑Clonidine TX MP NP 100 5 100
a Catapres 100 IX MP NP 100 5 100
a APO‑Clonidine TX MP NP P14141 200 5 100
a Catapres 100 IX MP NP P14141 200 5 100
Tablet containing clonidine hydrochloride 150 micrograms Oral Catapres IX MP NP 100 5 100
MP NP P14141 200 5 100

  1. Schedule 1, Part 1, entry for Clopidogrel

substitute:

Clopidogrel Tablet 75 mg (as besilate) Oral BTC Clopidogrel JB MP NP 28 5 28
Clopidogrel GH GQ MP NP 28 5 28
Clovix 75 RW MP NP 28 5 28
Plidogrel RF MP NP 28 5 28
BTC Clopidogrel JB MP NP P14141 56 5 28
Clopidogrel GH GQ MP NP P14141 56 5 28
Clovix 75 RW MP NP P14141 56 5 28
Plidogrel RF MP NP P14141 56 5 28
Tablet 75 mg (as hydrogen sulfate) Oral Clopidogrel Lupin GQ MP NP 28 5 28
Clopidogrel Sandoz Pharma HX MP NP 28 5 28
Clopidogrel Winthrop WA MP NP 28 5 28
Iscover AV MP NP 28 5 28
Piax AF MP NP 28 5 28
Plavicor 75 CR MP NP 28 5 28
Clopidogrel Lupin GQ MP NP P14141 56 5 28
Clopidogrel Sandoz Pharma HX MP NP P14141 56 5 28
Clopidogrel Winthrop WA MP NP P14141 56 5 28
Iscover AV MP NP P14141 56 5 28
Piax AF MP NP P14141 56 5 28
Plavicor 75 CR MP NP P14141 56 5 28

  1. Schedule 1, Part 1, entry for Clopidogrel with aspirin

substitute:

Clopidogrel with aspirin Tablet 75 mg (as hydrogen sulfate)‑100 mg Oral a APX‑Clopidogrel/Aspirin 75/100 TY MP NP 30 5 30
a Clopidogrel Winthrop plus aspirin WA MP NP 30 5 30
a CLOPIDOGREL/ASPIRIN AN 75/100 ED MP NP 30 5 30
a DuoCover AV MP NP 30 5 30
a DuoPlidogrel GZ MP NP 30 5 30
a Piax Plus Aspirin AF MP NP 30 5 30
a APX‑Clopidogrel/Aspirin 75/100 TY MP NP P14141 60 5 30
a Clopidogrel Winthrop plus aspirin WA MP NP P14141 60 5 30
a CLOPIDOGREL/ASPIRIN AN 75/100 ED MP NP P14141 60 5 30
a DuoCover AV MP NP P14141 60 5 30
a DuoPlidogrel GZ MP NP P14141 60 5 30
a Piax Plus Aspirin AF MP NP P14141 60 5 30

  1. Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 110 mg (as mesilate)

substitute:

Capsule 110 mg (as mesilate) Oral Pradaxa BY MP NP C4269 C4369 C4381 C4402 C14078 P4381 20 0 10
MP NP C4269 C4369 C4381 C4402 C14078 P4369 20 1 10
MP NP C4269 C4369 C4381 C4402 C14078 P4402 60 0 60
MP NP C4269 C4369 C4381 C4402 C14078 P4269 60 5 60
MP NP C4269 C4369 C4381 C4402 C14078 P14078 120 5 60

  1. Schedule 1, Part 1, entry for Dabigatran etexilate in the form Capsule 150 mg (as mesilate)

substitute:

Capsule 150 mg (as mesilate) Oral Pradaxa BY MP NP C4269 C14078 P4269 60 5 60
MP NP C4269 C14078 P14078 120 5 60

  1. Schedule 1, Part 1, entry for Enalapril

substitute:

Enalapril Tablet containing enalapril maleate 5 mg Oral a Acetec AL MP NP 30 5 30
a APO‑Enalapril TX MP NP 30 5 30
a Enalapril generichealth GQ MP NP 30 5 30
a Enalapril Sandoz SZ MP NP 30 5 30
a Malean RW MP NP 30 5 30
a Acetec AL MP NP P14141 60 5 30
a APO‑Enalapril TX MP NP P14141 60 5 30
a Enalapril generichealth GQ MP NP P14141 60 5 30
a Enalapril Sandoz SZ MP NP P14141 60 5 30
a Malean RW MP NP P14141 60 5 30
Tablet containing enalapril maleate 10 mg Oral a Acetec AL MP NP 30 5 30
a APO‑Enalapril TX MP NP 30 5 30
a Enalapril generichealth GQ MP NP 30 5 30
a Enalapril Sandoz SZ MP NP 30 5 30
a Malean RW MP NP 30 5 30
a Renitec AF MP NP 30 5 30
a Acetec AL MP NP P14141 60 5 30
a APO‑Enalapril TX MP NP P14141 60 5 30
a Enalapril generichealth GQ MP NP P14141 60 5 30
a Enalapril Sandoz SZ MP NP P14141 60 5 30
a Malean RW MP NP P14141 60 5 30
a Renitec AF MP NP P14141 60 5 30
Tablet containing enalapril maleate 20 mg Oral a Acetec AL MP NP 30 5 30
a APO‑Enalapril TX MP NP 30 5 30
a Enalapril generichealth GQ MP NP 30 5 30
a Enalapril Sandoz SZ MP NP 30 5 30
a Malean RW MP NP 30 5 30
a Renitec 20 AF MP NP 30 5 30
a Acetec AL MP NP P14141 60 5 30
a APO‑Enalapril TX MP NP P14141 60 5 30
a Enalapril generichealth GQ MP NP P14141 60 5 30
a Enalapril Sandoz SZ MP NP P14141 60 5 30
a Malean RW MP NP P14141 60 5 30
a Renitec 20 AF MP NP P14141 60 5 30

  1. Schedule 1, Part 1, entry for Enalapril with hydrochlorothiazide

substitute:

Enalapril with hydrochlorothiazide Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg Oral a Enalapril/HCT Sandoz SZ MP NP C4389 C14107 P4389 30 5 30
a Renitec Plus 20/6 AF MP NP C4389 C14107 P4389 30 5 30
a Enalapril/HCT Sandoz SZ MP NP C4389 C14107 P14107 60 5 30
a Renitec Plus 20/6 AF MP NP C4389 C14107 P14107 60 5 30

  1. Schedule 1, Part 1, entry for Eplerenone

substitute:

Eplerenone Tablet 25 mg Oral a APO‑Eplerenone TX MP NP C4937 C14035 P4937 30 5 30
a ESPLER RW MP NP C4937 C14035 P4937 30 5 30
a Inpler AF MP NP C4937 C14035 P4937 30 5 30
a Inspra UJ MP NP C4937 C14035 P4937 30 5 30
a APO‑Eplerenone TX MP NP C4937 C14035 P14035 60 5 30
a ESPLER RW MP NP C4937 C14035 P14035 60 5 30
a Inpler AF MP NP C4937 C14035 P14035 60 5 30
a Inspra UJ MP NP C4937 C14035 P14035 60 5 30
Tablet 50 mg Oral a APO‑Eplerenone TX MP NP C4937 C14035 P4937 30 5 30
a ESPLER RW MP NP C4937 C14035 P4937 30 5 30
a Inpler AF MP NP C4937 C14035 P4937 30 5 30
a Inspra UJ MP NP C4937 C14035 P4937 30 5 30
a APO‑Eplerenone TX MP NP C4937 C14035 P14035 60 5 30
a ESPLER RW MP NP C4937 C14035 P14035 60 5 30
a Inpler AF MP NP C4937 C14035 P14035 60 5 30
a Inspra UJ MP NP C4937 C14035 P14035 60 5 30

  1. Schedule 1, Part 1, entry for Ezetimibe

substitute:

Ezetimibe Tablet 10 mg Oral a APO‑Ezetimibe TX MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a Blooms The Chemist Ezetimibe IB MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a BTC Ezetimibe BG MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a EZEMICHOL RW MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a Ezetimibe GH GQ MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a Ezetimibe Sandoz SZ MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a Ezetrol AL MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a Pharmacor Ezetimibe 10 CR MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a Zient 10mg AF MP NP C7966 C7990 C7996 C14135 C14136 C14137 P7966 P7990 P7996 30 5 30
a APO‑Ezetimibe TX MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a Blooms The Chemist Ezetimibe IB MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a BTC Ezetimibe BG MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a EZEMICHOL RW MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a Ezetimibe GH GQ MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a Ezetimibe Sandoz SZ MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a Ezetrol AL MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a Pharmacor Ezetimibe 10 CR MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30
a Zient 10mg AF MP NP C7966 C7990 C7996 C14135 C14136 C14137 P14135 P14136 P14137 60 5 30

  1. Schedule 1, Part 1, entry for Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)

substitute:

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium) Oral a Ezalo Composite Pack 10mg+10mg AF MP NP C7957 C14057 P7957 1 5 1
a Pharmacor Ezetimibe Rosuvastatin Composite Pack CR MP NP C7957 C14057 P7957 1 5 1
a Rosuzet Composite Pack AL MP NP C7957 C14057 P7957 1 5 1
a Ezalo Composite Pack 10mg+10mg AF MP NP C7957 C14057 P14057 2 5 1
a Pharmacor Ezetimibe Rosuvastatin Composite Pack CR MP NP C7957 C14057 P14057 2 5 1
a Rosuzet Composite Pack AL MP NP C7957 C14057 P14057 2 5 1

  1. Schedule 1, Part 1, entry for Ezetimibe and rosuvastatin in the form Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)

substitute:

Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium) Oral a Ezalo Composite Pack 10mg+20mg AF MP NP C7957 C14057 P7957 1 5 1
a Pharmacor Ezetimibe Rosuvastatin Composite Pack CR MP NP C7957 C14057 P7957 1 5 1
a Rosuzet Composite Pack AL MP NP C7957 C14057 P7957 1 5 1
a Ezalo Composite Pack 10mg+20mg AF MP NP C7957 C14057 P14057 2 5 1
a Pharmacor Ezetimibe Rosuvastatin Composite Pack CR MP NP C7957 C14057 P14057 2 5 1
a Rosuzet Composite Pack AL MP NP C7957 C14057 P14057 2 5 1

  1. Schedule 4, Part 1, entry for Febuxostat

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C8921”: P8921

(b)insert in numerical order after existing text:

C14121 P14121 Chronic gout
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND
Patient must have a medical contraindication to allopurinol; OR
Patient must have a documented history of allopurinol hypersensitivity syndrome; OR
Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14121

  1. Schedule 4, Part 1, after entry for Febuxostat

insert:

Felodipine P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Fenofibrate

insert in numerical order after existing text:

P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Fluvastatin

insert in numerical order after existing text:

P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Fulvestrant

insert:

Furosemide P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Glucose indicator‑urine

insert:

Glyceryl trinitrate P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Hyaluronic acid

insert:

Hydralazine P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Hydralazine

insert:

Hydrochlorothiazide P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Hydrochlorothiazide

insert:

Hydrochlorothiazide with amiloride P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Indacaterol with mometasone

insert:

Indapamide P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Ipratropium

insert:

Irbesartan P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Irbesartan with hydrochlorothiazide

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4374”: P4374

(b)insert in numerical order after existing text:

C14061 P14061 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic.

  1. Schedule 4, Part 1, after entry for Isoleucine with carbohydrate

insert:

Isosorbide dinitrate P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Isosorbide dinitrate

insert:

Isosorbide mononitrate P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Ketoprofen

insert:

Labetalol P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Lenvatinib

insert:

Lercanidipine P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Lercanidipine with enalapril

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4398”: P4398

(b)insert in numerical order after existing text:

C14049 P14049 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.

  1. Schedule 4, Part 1, after entry for Lisdexamfetamine

insert:

Lisinopril P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Mesalazine

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C9443”: P9443

(b)insert in the column headed “Purposes Code” for the Circumstances Code “C9444”: P9444

(c)insert in numerical order after existing text:

C14023 P14023

Ulcerative colitis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
C14024 P14024

Crohn disease

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
C14120 P14120

Ulcerative colitis

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Methyldopa

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C13887”: P13887

(b)insert in numerical order after existing text:

C14141 P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Metoclopramide

insert:

Metoprolol P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Metoprolol succinate

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C5324”: P5324

(b)insert in numerical order after existing text:

C14033 P14033 Moderate to severe heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated.

  1. Schedule 4, Part 1, entry for Moxonidine

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4944”: P4944

(b)insert in numerical order after existing text:

C14037 P14037 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be receiving concurrent antihypertensive therapy.

  1. Schedule 4, Part 1, entry for Nebivolol

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C5324”: P5324

(b)insert in numerical order after existing text:

C14033 P14033 Moderate to severe heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated.

  1. Schedule 4, Part 1, after entry for Nevirapine

insert:

Nicorandil P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Nicotine

insert:

Nifedipine P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Olaparib

insert:

Olmesartan P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Olmesartan with amlodipine

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4373”: P4373

(b)insert in numerical order after existing text:

C14043 P14043 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.

  1. Schedule 4, Part 1, entry for Olmesartan with amlodipine and hydrochlorothiazide

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4311”: P4311

(b)insert in numerical order after existing text:

C14062 P14062 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.

  1. Schedule 4, Part 1, entry for Olmesartan with hydrochlorothiazide

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4374”: P4374

(b)insert in numerical order after existing text:

C14061 P14061 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic.

  1. Schedule 4, Part 1, entry for Pancreatic extract

insert in numerical order after existing text:

P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Pembrolizumab

insert:

Penicillamine P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Perhexiline

insert:

Perindopril P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Perindopril with amlodipine

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4398”: P4398

(b)insert in the column headed “Purposes Code” for the Circumstances Code “C4418”: P4418

(c)insert in numerical order after existing text:

C14049 P14049 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.
C14068 P14068 Stable coronary heart disease
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of therapy for coronary heart disease; AND
The condition must be stabilised by treatment with perindopril and amlodipine at the same doses.

  1. Schedule 4, Part 1, entry for Perindopril with indapamide

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4375”: P4375

(b)insert in numerical order after existing text:

C14098 P14098 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a thiazide‑like diuretic.
P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Posaconazole

insert:

Potassium chloride P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Potassium chloride

insert:

Potassium chloride with potassium bicarbonate P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Pravastatin

insert in numerical order after existing text:

P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Praziquantel

insert:

Prazosin P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Pregabalin

insert:

Probenecid P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Propantheline

insert:

Propranolol P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Quinagolide

insert:

Quinapril P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Raloxifene

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C6314”: P6314

(b)insert in numerical order after existing text:

C14101 P14101 Established post‑menopausal osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x‑ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14101

  1. Schedule 4, Part 1, after entry for Raltegravir

insert:

Ramipril P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Ramipril with felodipine

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4398”: P4398

(b)insert in numerical order after existing text:

C14049 P14049 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.

  1. Schedule 4, Part 1, entry for Risedronic acid

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C6310”: P6310

(b)insert in the column headed “Purposes Code” for the Circumstances Code “C6323”: P6323

(c)insert in the column headed “Purposes Code” for the Circumstances Code “C6327”: P6327

(d)insert in numerical order after existing text:

C14027 P14027 Established osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x‑ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
C14028 P14028 Osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T‑score of ‑2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C14089 P14089 Corticosteroid‑induced osteoporosis
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must currently be on long‑term (at least 3 months), high‑dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T‑score of ‑1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

  1. Schedule 4, Part 1, entry for Rivaroxaban

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4099”: P4099

(b)insert in the column headed “Purposes Code” for the Circumstances Code “C4268”: P4268

(c)insert in the column headed “Purposes Code” for the Circumstances Code “C10992”: P10992

(d)insert in the column headed “Purposes Code” for the Circumstances Code “C11013”: P11013

(e)insert in numerical order after existing text:

C14059 P14059 Prevention of stroke or systemic embolism
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have non‑valvular atrial fibrillation; AND
Patient must have one or more risk factors for developing stroke or systemic embolism.
Risk factors for developing stroke or systemic ischaemic embolism are:
(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non‑central nervous system (CNS) systemic embolism;
(ii) age 75 years or older;
(iii) hypertension;
(iv) diabetes mellitus;
(v) heart failure and/or left ventricular ejection fraction 35% or less. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14059
C14075 P14075 Chronic stable atherosclerotic disease
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be in combination with aspirin, but not with any other anti‑platelet therapy. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14075
C14095 P14095 Deep vein thrombosis
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have confirmed acute symptomatic deep vein thrombosis; AND
Patient must not have symptomatic pulmonary embolism. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14095
C14116 P14116 Chronic stable atherosclerotic disease
Initial treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with aspirin, but not with any other anti‑platelet therapy; AND
Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors: (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15‑60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; OR
Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors: (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15‑60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND
Patient must have at least one of the following if coronary artery disease is present: (i) a previous multi‑vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; OR
Patient must have at least one of the following if peripheral arterial disease is present: (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle‑brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND
The condition must be diagnosed by at least one of: (i) invasive (selective) angiography (ii) non‑invasive imaging (i.e. CT scan, ultrasound) (iii) ankle‑brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND
Patient must have clinical findings/observations by the treating physician that exclude each of the following: (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non‑acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy.
Must be treated by a specialist physician; OR
Must be treated by a physician who has consulted a specialist physician. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14116
C14139 P14139 Prevention of recurrent venous thromboembolism
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have a history of venous thromboembolism. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14139
C14140 P14140 Pulmonary embolism
Continuing treatment
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must have confirmed acute symptomatic pulmonary embolism. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14140

  1. Schedule 4, Part 1, entry for Rosuvastatin

insert in numerical order after existing text:

P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Sacubitril with valsartan

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C11680”: P11680

(b)insert in numerical order after existing text:

C14051 P14051 Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta‑blocker, unless at least one of the following is present in relation to the beta‑blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta‑blocker; AND
Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA‑approved Product Information or cannot be tolerated; AND
The treatment must not be co‑administered with an ACE inhibitor or an angiotensin II antagonist. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14051

  1. Schedule 4, Part 1, entry for Simvastatin

insert in numerical order after existing text:

P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Soy protein and fat formula with vitamins and minerals ‑‑ carbohydrate free

insert:

Spironolactone P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Sulfasalazine

insert in numerical order after existing text:

P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, after entry for Tapentadol

insert:

Telmisartan P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Telmisartan with amlodipine

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4373”: P4373

(b)insert in numerical order after existing text:

C14043 P14043 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.

  1. Schedule 4, Part 1, entry for Telmisartan with hydrochlorothiazide

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4374”: P4374

(b)insert in numerical order after existing text:

C14061 P14061 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic.

  1. Schedule 4, Part 1, entry for Thiamine

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C5139”: P5139

(b)insert in numerical order after existing text:

C14020 P14020 Thiamine deficiency
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be for prophylaxis.
Patient must be an Aboriginal or a Torres Strait Islander person. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14020

  1. Schedule 4, Part 1, entry for Ticagrelor

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C5746”: P5746

(b)insert in numerical order after existing text:

C14076 P14076 Acute coronary syndrome (myocardial infarction or unstable angina)
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with aspirin. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 14076

  1. Schedule 4, Part 1, after entry for Trametinib

insert:

Trandolapril P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Trandolapril with verapamil

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4390”: P4390

(b)insert in numerical order after existing text:

C14119 P14119 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with verapamil.

  1. Schedule 4, Part 1, after entry for Valine with carbohydrate

insert:

Valsartan P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.

  1. Schedule 4, Part 1, entry for Valsartan with hydrochlorothiazide

(a)insert in the column headed “Purposes Code” for the Circumstances Code “C4361”: P4361

(b)insert in the column headed “Purposes Code” for the Circumstances Code “C4374”: P4374

(c)insert in numerical order after existing text:

C14061 P14061 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic.
C14108 P14108 Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic.

  1. Schedule 4, Part 1, after entry for Venlafaxine

insert:

Verapamil P14141 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
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