Proposed approval of a new active Buprenorphine and registration of the product Bupredyne Injection containing Buprenorphine

The APVMA is considering an application for the approval of a new active buprenorphine and registration of bupredyne injection. The product is to be used as an analgesic injection in dogs and cats.

We invite comment from 11 August 2015 to 8 September 2015 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; and
• trade criteria

For more information see the APVMA Gazette Notice (page 21) from 11 August 2015

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