Zulvac 1+8 Bovis

Authorised

This medicine is authorised for use in the European Union

inactivated bluetongue virus, serotypes 1 and 8

Overview

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

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

Reference Number: EMA/CVMP/39462/2012

Product information

Zulvac 1+8 Bovis : EPAR - Product Information

Zulvac 1+8 Bovis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zulvac 1+8 Bovis
• Active substance:
  • inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP
  • inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
• International non-proprietary name (INN) or common name:
  inactivated bluetongue virus, serotypes 1 and 8

Pharmacotherapeutic group

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

Authorisation details

• EMA product number:
  EMEA/V/C/002473
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Assessment history

Changes since initial authorisation of medicine

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

Zulvac 1+8 Bovis-V-C-2473-S-0003 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/603758/2013

Initial marketing authorisation documents

Zulvac 1+8 Bovis : EPAR - Public assessment report

Adopted Reference Number: EMA/CVMP/973396/2011

CVMP summary of positive opinion for Zulvac 1+8 Bovis

Adopted