This consultation closed on 9 August 2022
The APVMA is considering an application for approval of the new active constituent bedinvetmab and registration of the suite of new products, Beransa 30 mg, Beransa 20 mg, Beransa 15 mg, Beransa 10 mg and Beransa 5 mg Solution for Injection for Dogs containing 30 mg/mL, 20 mg/mL, 15 mg/mL, 10 mg/mL and 5 mg/mL bedinvetmab. The products are used for the alleviation of pain associated with osteoarthritis in dogs.
We invite comments from 12 July 2022 to 9 August 2022 on whether approval of the active constituent and registration of the products should be granted.
The APVMA is able to consider comments relating to the legislative grounds, including:
- chemistry and manufacture
- occupational health and safety
- public health
- environmental safety
- efficacy and target animal safety.
For more information see page 18, APVMA Gazette No. 14, 12 July 2022.
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:
Email: enquiries@apvma.gov.au
Post:
Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001