Proposed approval of clodronate disodium tetrahydrate and the registration of Osphos 51 mg/ml Solution for Injection for Horses

The APVMA is considering an application for the approval of clodronate disodium tetrahydrate and registration of Osphos 51 mg/ml Solution for Injection for Horses. The product is to be used for the improvement of lameness associated with navicular syndrome in horses.

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:

• chemistry and manufacture
• safety criteria
• efficacy criteria
• trade criteria.

For more information see page 37 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