You are here

Scheduling delegate's final decisions, March 2017

Scheduling medicines and poisons

23 March 2017

Book pagination

3. Summary of delegate's final decisions

Part A - Final decisions on matters referred to an expert advisory committee

3. Advisory Committee on Medicines Scheduling (ACMS #19)

Summary of delegate’s final decisions

The final decisions listed below all have an implementation date of 1 June 2017 unless separately specified.

Substance Final decision
Vitamin D

Appendix H - New Entry

VITAMIN D

Melatonin The current scheduling for melatonin remains appropriate.
Paracetamol/caffeine

Schedule 2 – Amend Entry

PARACETAMOL for therapeutic use:

  1. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
  2. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
  3. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or
  4. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
  5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or
  6. in other preparations except:
    1. when included in Schedule 3 or 4; or
    2. in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
      2. compliant with the requirements of the Required Advisory Statements for Medicine Labels.
      3. not labelled for the treatment of children 6 years of age or less, and
      4. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. packed in blister or strip packaging or in a container with a child-resistant closure,
      2. in a primary pack containing not more than 20 tablets or capsules,
      3. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      4. not labelled for the treatment of children 6 years of age or less, and
      5. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
Vardenafil The current scheduling of vardenafil remains appropriate.
Cetirizine hydrochloride

Schedule 4 –Amend Entry

CETIRIZINE HYDROCHLORIDE except:

  1. when included in Schedule 2 ; or
  2. in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing not more than 10 days’ supply; and
    2. labelled with a recommended daily dose not exceeding 10 mg of cetirizine hydrochloride.

Schedule 2 –Amend Entry

CETIRIZINE HYDROCHLORIDE in preparations for oral use except in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age an over when:

  1. in a primary pack containing not more than 10 days’ supply; and
  2. labelled with a recommended daily dose not exceeding 10 mg of cetirizine hydrochloride.
Tianeptine

Schedule 4 – New Entry

TIANEPTINE.

Appendix D Item 5 – New Entry

TIANEPTINE.

Olaparib

Schedule 4 – New Entry

OLAPARIB.

Ceritinib

Schedule 4 – New Entry

CERITINIB.

Panobinostat lactate

Schedule 4 – New Entry

PANOBINOSTAT.

Brivaracetam

Schedule 4 – New Entry

BRIVARACETAM.

Appendix K – New Entry

BRIVARACETAM.

Guanfacine hydrochloride

Schedule 4 – New Entry

GUANFACINE.

Appendix K – New Entry

BRIVARACETAM.

Follitropin delta

Schedule 4 – New Entry

#FOLLITROPIN DELTA.

Appendix D, Item 1 – New Entry

FOLLITROPIN DELTA (recombinant human follicle-stimulating hormone) for human use.

Index – New Entry

FOLLITROPIN DELTA

cross reference: FOLLICLE-STIMULATING HORMONE, RECOMBINANT HUMAN

Schedule 4

Appendix D, Item 1

Book pagination