This content is current only at the time of printing. This document was printed on 25 February 2020. A current copy is located at https://apvma.gov.au/node/12336
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Oclacitinib in the products Apoquel 16 mg, Apoquel 5.4 mg and Apoquel 3.6 mg
This consultation closed on 16 December 2014.
Proposed approval of oclacitinib and registration of the products Apoquel 16 mg, Apoquel 5.4 mg and Apoquel 3.6 mg containing oclacitinib.
The APVMA is considering applications for the approval of oclacitinib and registration of Apoquel 16 mg, Apoquel 5.4 mg and Apoquel 3.6 mg. The products are to be used for the treatment of pruritus associated with allergic dermatitis in dogs, and treatment of the clinical manifestations of atopic dermatitis in dogs.
We invite comment from 18 November 2014 to 16 December 2014 on whether the application for approval of the active constituent and/or registration of the products should be granted.
The APVMA is able to consider comments relating to the legislative grounds for registration, including:
- safety criteria
- efficacy criteria
- trade criteria
For more information see page 9 of Gazette No. 23
Please send your written submission by email, post or fax to:
Registration Management and Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182 Kingston ACT 2604
Fax: +61 2 6210 4721
Phone: +61 2 6210 4701