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