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Final decisions amending, or not amending, the current Poisons Standard, November 2018

Part A - Amendments to the Poisons Standard referred to expert advisory committee

29 November 2018

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2.4. Astodrimer sodium

2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #19)

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the current Poisons Standard in relation to astodrimer sodium as follows:

Note

New text is shown as green, larger font, with a horizontal line above it.

Schedule 3 - New Entry

ASTODRIMER SODIUM except in a condom lubricant.

Appendix F, Part 1 - New Entries

109 See your healthcare provider if you consider that you may be at risk of a Sexually Transmitted Infection (STI).
110 See a doctor if you plan to become pregnant, or are breastfeeding or plan to breastfeed

Appendix F, Part 3 - New Entry

ASTODRIMER SODIUM

Warning statements: 63, 64, 69, 75, 109, 110.

Appendix H - New Entry

ASTODRIMER SODIUM for the treatment and relief of bacterial vaginosis.

Index - New Entry

ASTODRIMER SODIUM

Schedule 3

Appendix F, Part 3

Appendix H

Implementation date: 1 February 2019

Reasons:

The delegate has amended the Appendix F warning statement in the interim decision after considering the public submission, and confirms that the reasons for the final decision remain the same as the reasons for the interim decision.

Public submissions on the interim decision

Two (2) public submissions were received before the second closing date in response to an invitation published on 10 September 2018 under regulation 42ZCZP of the Regulations. One submission was in support and one opposed the proposal.

The main points provided in opposition of the amendment were:

  • A S2 entry would have been more appropriate
  • Warning label 110 should be deleted as it is sufficiently covered by warning labels 64, 69, 109
  • Amend warning label 111 to read 'See a doctor if you plan to become pregnant, or are breastfeeding or plan to breastfeed'

The main points provided in support of the amendment were:

  • The S3 entry is better than the S4 entry originally proposed
  • The substance may be suitable for S2 listing in the future
  • Supports inclusion in Appendix H

Interim decision

The interim decision was published on the TGA website on 10 September 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS, September 2018 – 2.4 Astodrimer sodium.

Scheduling proposal

The pre-meeting scheduling proposal for codeine was published on the TGA website on 10 April 2018 at Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS.

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