This consultation closed on 4 October 2022
The APVMA is considering an application for the approval of a new active constituent ciclesonide, and an application for registration of a new product containing the new active constituent. The product is Aservo EquiHaler for the management of clinical signs associated with moderate to severe equine asthma in horses.
We invite comments from 6 September 2022 to 4 October 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 22, APVMA Gazette No. 18, 6 September 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