Advocate
Opinion
On 16 March 2022, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Advocate. The marketing authorisation holder for this veterinary medicinal product is Bayer Animal Health GmbH.
Advocate is currently authorised as spot-on solution in cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections. The variation concerns the addition of a new therapeutic indication for the treatment of the lungworm Troglostrongylus brevior (adults) in cats. Also, the applicant takes the opportunity to make some editorial amendments to the package leaflet.
Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.
Key facts
Name |
Advocate |
Agency product number |
EMEA/V/C/000076 |
International non-proprietary name (INN) or common name |
|
Species |
Dogs
Cats
Ferrets
|
Active substance |
|
Date opinion adopted |
16/03/2022 |
Company name | |
Status |
Positive |
Application type |
Post-authorisation |