Imepitoin in the products Pexion 400 mg Tablets for Dogs and Pexion 100 mg Tablets for Dogs

Proposed approval of imepitoin and registration of the products Pexion 400 mg Tablets for Dogs and Pexion 100 mg Tablets for Dogs containing imepitoin.

The APVMA is considering applications for the approval of imepitoin and registration of Pexion 400 mg Tablets for Dogs and Pexion 100 mg Tablets for Dogs. The products are to be used as an antiepileptic agent for use as an aid in the treatment of epilepsy 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 4 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