Zulvac 8 Ovis

Authorised

This medicine is authorised for use in the European Union

inactivated bluetongue virus, serotype 8

Overview

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

Zulvac 8 Ovis : EPAR - Summary for the public

Product information

Zulvac 8 Ovis : EPAR - Product Information

Zulvac 8 Ovis : EPAR - All Authorised presentations

Product details

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

Pharmacotherapeutic group

Immunologicals

Authorisation details

• EMA product number:
  EMEA/V/C/000147

Assessment history

Changes since initial authorisation of medicine

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

Zulvac 8 Ovis-V-C-147-S-09 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/276752/2013

Zulvac 8 Ovis-V-C-147-II-01 : EPAR - Scientific Discussion - Variation

Adopted Reference Number: EMA/66099/2011

Initial marketing authorisation documents

Zulvac 8 Ovis : EPAR - Procedural steps taken before authorisation

Zulvac 8 Ovis : EPAR - Scientific Discussion

CVMP summary of opinion for Zulvac 8 Ovis

Adopted Reference Number: EMEA/CVMP/665795/2008