Leucofeligen FeLV/RCP
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 Leucofeligen FeLV/RCP. The marketing authorisation holder for this veterinary medicinal product is Virbac S.A.
Leucofeligen FeLV/RCP is currently authorised as lyophilisate and suspension for suspension for injection. The variation concerns to change the onset of immunity for the calicivirus component of the vaccine from 4 weeks after primary vaccination to 3 weeks after first vaccine injection of primary 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.
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 |
Leucofeligen FeLV/RCP |
| Agency product number |
EMEA/V/C/000143 |
| International non-proprietary name (INN) or common name |
|
| Species |
Cats
|
| Active substance |
|
| Date opinion adopted |
25/05/2020 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |