New veterinary chemical product containing a new veterinary active constituent: CosACTHen 0.25 mg/mL Solution for Dogs

The APVMA is considering an application for approval of the new active constituent, tetracosactide and the registration of the product, CosACTHen 0.25mg/mL Solution for Injection for Dogs, for the evaluation of adrenocortical function in dogs.

We invite comments from 5 March 2024 to 1 April 2024 on whether approval of the active constituent and registration of the product should be granted.

The APVMA is able to consider comments relating to the legislative grounds, including:

Gazette No 5, 5 March 2024

Contents

  • Agricultural chemical products and approved labels – 1
  • Veterinary chemical products and approved labels – 8
  • Approved active constituents – 13
  • New veterinary chemical product containing a new veterinary active constituent – 19
  • Licensing of veterinary chemical manufacturers – 25
  • Amendments to the APVMA MRL Standard – 26
  • Proposal to amend Schedule 20 in the Australian New Zealand Food Standards Code – 27
  • Notice of cancellation at the request of the holder – 31

Special Gazette, 27 February 2024

Contents

  • Neomycin reconsideration – proposed decisions on reconsideration – 1
  • Attachment A: Product registration(s) and label approval(s) placed under reconsideration – 3
  • Attachment B: Statement of Reasons – 4
  • Attachment C: Information on which the reasons are based – 33
  • Attachment D: Proposed varied labels for neomycin chemical products – 35
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