Zulvac BTV
Opinion
On 20 May 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Zulvac BTV. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium SA.
Zulvac BTV is currently authorised as suspension for injection. The variation concerns the variation of the existing multi-strain dossier in order to allow the use of the current monovalent vaccine against serotype 4 in cattle. The MAH is taking the opportunity to update Annex II of the product information.
Detailed conditions for the use of this product are described in the updated 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 |
Zulvac BTV |
| Agency product number |
EMEA/V/C/004185 |
| International non-proprietary name (INN) or common name |
|
| Species |
Sheep
Cattle
|
| Active substance |
|
| Date opinion adopted |
20/05/2020 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |