Zulvac 1+8 Ovis

Authorised

This medicine is authorised for use in the European Union

inactivated bluetongue serotype 1+8 vaccine

Overview

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

Zulvac 1+8 Ovis : EPAR - Summary for the public

Reference Number: EMA/CVMP/622534/2010

Product information

Zulvac 1+8 Ovis : EPAR - Product Information

Zulvac 1+8 Ovis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zulvac 1+8 Ovis
• Active substance:
  • inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01
  • inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
• International non-proprietary name (INN) or common name:
  inactivated bluetongue serotype 1+8 vaccine

Pharmacotherapeutic group

• Inactivated viral vaccines
• bluetongue virus
• SHEEP

Authorisation details

• EMA product number:
  EMEA/V/C/002251

Assessment history

Changes since initial authorisation of medicine

Zulvac 1+8 Ovis : EPAR - Procedural steps taken and scientific information after authorisation

Zulvac 1+8 Ovis-V-C-2251-S-0006 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/382652/2013

Initial marketing authorisation documents

Zulvac 1+8 Ovis : EPAR - Scientific Discussion

Reference Number: EMA/295791/2010

CVMP summary of positive opinion for Zulvac 1+8 Ovis

Adopted Reference Number: EMA/CVMP/295355/2010