Oclacitinib in the products Apoquel 16 mg, Apoquel 5.4 mg and Apoquel 3.6 mg

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:

Enquiries
Registration Management and Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182 Kingston ACT 2604

email:    enquiries@apvma.gov.au  
Fax:      +61 2 6210 4721
Phone:  +61 2 6210 4701