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 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:

• A new posology (change to the posology for sheep, to vaccinate with one single dose of the bivalent vaccine BTV1+4).

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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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.

CVMP post-authoirsation summary of positive opinion for Bluevac BTV

AdoptedReference Number: EMAVRA0000255727

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:
  15/05/2025
• Status:
  Positive