Zulvac BTV

Authorised

This medicine is authorised for use in the European Union

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

Overview

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

Zulvac BTV : EPAR - Medicine overview

Product information

Zulvac BTV : EPAR - Product Information

Zulvac BTV : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zulvac BTV
• 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)

Pharmacotherapeutic group

• Immunologicals
• Immunologicals for Bovidae
• Inactivated viral vaccines
• bluetongue virus
• SHEEP

Authorisation details

• EMA product number:
  EMEA/V/C/004185

Assessment history

Changes since initial authorisation of medicine

Zulvac BTV : EPAR - Procedural steps taken and scientific information after authorisation

Zulvac BTV-V-C-4185-II-0004 : Assessment report - Variation

Adopted Reference Number: EMA/519278/2019

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

Adopted Reference Number: EMA/CVMP/235910/2020

Zulvac BTV-V-C-4185-X-0001 : Assessment report - Variation

Adopted Reference Number: EMA/870927/2018

CVMP post-authorisation summary of positive opinion for Zulvac BTV Ovis

Adopted Reference Number: EMA/CVMP/808341/2018

Initial marketing authorisation documents

Zulvac BTV Ovis : EPAR - Public assessment report

Adopted Reference Number: EMA/118000/2017

CVMP summary of positive opinion for Zulvac BTV Ovis

Adopted Reference Number: EMA/CVMP/50456/2017