Proposed approval of terbinafine and registration of the product Osurnia Ear Gel for Dogs

The APVMA is considering an application for the approval of terbinafine and registration of Osurnia Ear Gel for Dogs. The product is proposed to be registered for the treatment of otitis externa in dogs.

We invite comment from 4 October 2016 to 1 November 2016 on whether the application for approval of the active constituent and/or registration of the product 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 24 of Gazette No. 20 from 4 October 2016

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