Syvazul BTV 3

Authorised

This medicine is authorised for use in the European Union

bluetongue virus vaccine (inactivated)

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Product details

• Name of medicine:
  Syvazul BTV 3
• Active substance:
  bluetongue virus, serotype 3, BTV-3/NET2023, inactivated
• International non-proprietary name (INN) or common name:
  bluetongue virus vaccine (inactivated)

Pharmacotherapeutic group

• Immunologicals for Ovidae
• Immunologicals for Bovidae
• Inactivated viral vaccines

Authorisation details

• EMA product number:
  EMEA/V/C/006623
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Assessment history

Changes since initial authorisation of medicine

CVMP post-authorisation summary of positive opinion for Syvazul BTV 3 (VRA-I -EMAVRA0000269481)

Adopted Reference Number: EMADOC-1700519818-2241723

Initial marketing authorisation documents

CVMP summary of positive opinion for Syvazul BTV 3

Reference Number: EMA/596315/2024