On 15 May 2025, 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 Bluevac BTV. The marketing authorisation holder for this veterinary medicinal product is CZ Vaccines S.A.U.
Bluevac BTV is currently authorised as a suspension for injection. The variation concerns:
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 Union Product Database (UPD) 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.
Name of medicine
Bluevac BTV (previously Bluevac BTV8)
EMA product number
EMEA/V/C/000156
Active substance
bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated]
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
Date of opinion
Status
Positive
