BTVPUR - opinion on variation to marketing authorisation

Opinion

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

inactivated vaccine against bluetongue virus serotypes 1 and 8

Opinion

On 21 May 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product BTVPUR. The marketing authorisation holder for this veterinary medicinal product is Boehringer Ingelheim Vetmedica GmbH.

BTVPUR is currently authorised for the active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes); for the active immunisation of cattle to prevent viraemia caused by bluetongue virus serotypes 1, 2, 4 and/or 8, and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of maximum 2 serotypes).

The variation concerns to update the product information by including a new vaccination practice against BTV8 in sheep. The modified therapeutic indication for sheep is below:

“Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).

For bluetongue virus serotype 8 in sheep (monovalent or in combination with serotypes 2–8 or 4–8), when only one injection is administered, the level of protection is limited to the reduction of viraemia and the reduction of clinical signs. Two injections are required for the prevention of viraemia.”

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 BTVPUR (VRA/0000322270)

Adopted Reference Number: EMADOC-1700519818-3149659

Key facts

• Name of medicine:
  BTVPUR
• EMA product number:
  EMEA/V/C/002231
• Active substance:
  • bluetongue-virus serotype-1 antigen
  • bluetongue virus serotype 8 antigen
• International non-proprietary name (INN) or common name:
  inactivated vaccine against bluetongue virus serotypes 1 and 8
• Date of opinion:
  21/05/2026
• Status:
  Positive