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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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1.2. Budesonide

1. Advisory Committee on Medicines Scheduling (ACMS #24)

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 budesonide as follows:

The delegate has confirmed that the reasons for the final decision align with the reasons for the interim decision. Additional reasons for the final decision are the following:

Note

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

Deleted text is shown as red, smaller font, with a strikethrough.

Schedule 2 – Amend Entry

BUDESONIDE in aqueous nasal sprays delivering 5064 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

Schedule 4 – (No change)

BUDESONIDE except when included in Schedule 2.

Index

BUDESONIDE
Schedule 4
Schedule 2

Implementation date: 1 February 2019

Reasons:

As no new evidence has been received to alter the interim decision for budesonide, the delegate has confirmed that the final decision and reasons for the final decision are identical to 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. Both submissions were in support of the interim decision.

The main point provided in support of the amendment was:

  • Agree with the delegate's interim decision that the S2 entry for budesonide be amended to increase the dose per actuation from 50 to 64 micrograms and remove the limit of 200 actuations, as budesonide has an excellent safety profile.

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: ACMS, September 2018 – 1.2 Budesonide.

Scheduling proposal

The pre-meeting scheduling proposal for budesonide 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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