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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, February 2016

Scheduling medicines and poisons

3 February 2016

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2 Summary

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

2. Scheduling proposals referred to the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#16)

Summary of delegate's interim decisions
Substance Final Decision
Bismuth oxychloride The delegate's interim decision is that the current scheduling for bismuth oxychloride remains appropriate
Naproxen

APPENDIX H - New entry

Proposed implementation date: 1 June 2016.

Paracetamol

Amend the Schedule 2 entry for paracetamol to include paracetamol when combined with ibuprofen in pack sizes of 12 dosage units or less.

The Schedule 2 and Schedule 3 entries for paracetamol should be amended as follows:

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 pack of not more than 3 day supply.
  2. in other preparations except:
    1. when included in Schedule 4.
    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 phenylephrine and/or guaiphenesin 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.
      4. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesin 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 phenylephrine and/or guaiphenesin.

Schedule 3 - Amend entry

PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2.

Proposed implementation date: 1 June 2016.

Piracetam The delegate's interim decision is that the current scheduling of piracetam remains appropriate.
Lansoprazole, omeprazole and rabeprazole

The delegate's interim decision is to include lansoprazole, omeprazole, rabeprazole in Schedule 2:

Lansoprazole

Schedule 2 - New entry

LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

Schedule 3 - Amend entry

LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply except when included in Schedule 2.

Schedule 4 - Amend entry

LANSOPRAZOLE except when included in Schedule 2 or 3.

Omeprazole

Schedule 2 - New entry

OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

Schedule 3 - Amend entry

OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2.

Schedule 4 - Amend entry

OMEPRAZOLE except when included in Schedule 2 or 3.

Rabeprazole

Schedule 2 - New entry

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply.

Schedule 3 - Amend entry

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply except when included in Schedule 2.

Schedule 4 - Amend entry

RABEPRAZOLE except when included in Schedule 2 or 3.

Proposed implementation date: 1 June 2016.

Flubromazolam

Schedule 9 - New entry

Flubromazolam

Proposed implementation date: 1 June 2016.

Thymosin Beta 4 (Thymosin β4)

Schedule 4 - New entries

Thymosin Beta 4 (Thymosin β4)

TB-500

Fibroblast Growth Factors

Appendix D, Item 5 - New entries

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