Senvelgo 15 mg/mL Oral Solution for Cats containing velagliflozin L-proline monohydrate

The APVMA is considering an application for approval of the new active constituent, velagliflozin L-proline monohydrate and the registration of the product, Senvelgo 15 mg/mL Oral Solution for Cats, is indicated for the reduction of hyperglycaemia and improvement in associated clinical signs in otherwise healthy cats with non-insulin dependent diabetes mellitus.

We invite comments from 1 October 2024 to 29 October 2024 on whether approval of the active constituent and registration of the product should be granted.

The APVMA is able to consider comments relating to the legislative grounds, including:

• chemistry and manufacture
• occupational health and safety
• environmental safety
• efficacy and target animal safety.

For more information see page 20, APVMA Gazette No. 20, 1 October 2024.

Please note: submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public consultation coversheet).

Please lodge your submission using the public consultation coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.

Please send your written submission and coversheet by email or post to:

Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
PO Box 574 Canberra ACT 2601

Phone: +61 2 6770 2300
Email: casemanagement@apvma.gov.au