This consultation closed on 16 September 2025
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, ilunocitinib, in conjunction with applications for the registration of a suite of new products, Zenrelia [4.8 mg, 6.4 mg, 8.5 mg, 15 mg] Tablets for Dogs, for the reduction of pruritus associated with allergic dermatitis and reduction of clinical signs of atopic dermatitis in dogs.
We invite relevant written comment from 19 August 2025 to 16 September 2025. Comment can be made on the application for the registration of Zenrelia [4.8 mg, 6.4 mg, 8.5 mg, 15 mg] Tablets for Dogs AND/OR the application for approval of ilunocitinib.
Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based.
For more information see page 19, APVMA Gazette No. 17, 19 August 2025.
Please note: submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public consultation coversheet).
Please lodge your submission using the public consultation coversheet, which provides options for how your submission will be published.
Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or post to:
Case Management
Australian Pesticides and Veterinary Medicines Authority
GPO Box 574
Canberra ACT 2601, Australia
Phone: +61 2 6770 2300
Email: casemanagement@apvma.gov.au