Zulvac BTV - opinion on variation to marketing authorisation

Opinion

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

bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)

Opinion

On 20 May 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion^₁, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Zulvac BTV. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium SA.

Zulvac BTV is currently authorised as suspension for injection. The variation concerns the variation of the existing multi-strain dossier in order to allow the use of the current monovalent vaccine against serotype 4 in cattle. The MAH is taking the opportunity to update Annex II of the product information.

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.

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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.

CVMP post-authorisation summary of positive opinion for Zulvac BTV (II-0004)

Adopted Reference Number: EMA/CVMP/235910/2020

Key facts

• Name of medicine:
  Zulvac BTV
• EMA product number:
  EMEA/V/C/004185
• Active substance:
  One of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
• International non-proprietary name (INN) or common name:
  bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)
• Species:
  • Sheep
  • Cattle
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI02AA
• Marketing authorisation holder:
  Zoetis Belgium SA
• Date of opinion:
  20/05/2020
• Status:
  Positive