Bluevac BTV (previously Bluevac BTV8) - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

Opinion

On 12 February 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a group of variations 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 for active immunisation of sheep to prevent viraemia caused by bluetongue virus serotype 1 and/or 4 and/or 8 and to reduce clinical signs caused by bluetongue virus serotype 8 (combination of maximum 2 serotypes), and for active immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1 and/or 4 and/or 8 (combination of maximum 2 serotypes).

The aim of these grouped variations is to allow up to the combination of a maximum of three different inactivated bluetongue virus serotypes (instead of a maximum of two serotypes), to be included in a final vaccine for sheep, and to align the product information with the latest version of the QRD available (version 9.1).

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.

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Note: 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.

CVMP post-authorisation summary of positive opinion for Bluevac BTV (EMA/VRA/0000293372)

Adopted Reference Number: EMADOC-1700519818-2907706

Key facts

• 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]
• Accelerated assessment:

  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:
  12/02/2026
• Status:
  Positive