Proposed approval of spironolactone and registration of Prilactone 80 mg tablets for dogs, Prilactone 10 mg tablets for dogs and Prilactone 40 mg tablets for dogs

The APVMA is considering an application for the approval of spironolactone and registration of Prilactone 80 mg tablets for dogs, Prilactone 10 mg tablets for dogs and Prilactone 40 mg tablets for dogs. The products are to be used use in conjunction with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by mitral valvular regurgitation in dogs.

We invite comment from 17 May 2016 to 14 June 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 APVMA Gazette notice (page 17) from 17 May 2016.

Please send your written submission by email, post or fax to:

Case Management and Administration Unit
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