Clynav
Opinion
On 20 February 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 Clynav. The marketing authorisation holder for this veterinary medicinal product is Elanco GmbH.
Clynav is currently authorised as a solution for injection. The variation concerns extending the duration of immunity from 3 months after vaccination to 12 months after vaccination.
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.
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 |
Clynav |
| Agency product number |
EMEA/V/C/002390 |
| International non-proprietary name (INN) or common name |
|
| Species |
Atlantic salmon
|
| Active substance |
|
| Date opinion adopted |
20/02/2020 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |