Bravecto Plus
Opinion
On 15 February 2023, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Bravecto Plus. The marketing authorisation holder for this veterinary medicinal product is Intervet International B.V.
Bravecto Plus is currently authorised as spot-on solution for use in cats. The grouped variation is to add a new therapeutic indication for the prevention of aelurostrongylosis (by preventing the establishment of adult Aelurostrongylus abstrusus responsible for clinical disease) and to align the product information with version 9.0 of the QRD template.
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.
1 Applicants 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 |
Bravecto Plus |
| Agency product number |
EMEA/V/C/004440 |
| International non-proprietary name (INN) or common name |
|
| Species |
Cats
|
| Active substance |
|
| Date opinion adopted |
15/02/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |