Zulvac 8 Bovis

Withdrawn

This medicine's authorisation has been withdrawn

inactivated bluetongue virus, serotype 8

Overview

The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.

Zulvac 8 Bovis : EPAR - Summary for the public

Reference Number: EMA/CVMP/643080/2009

Product information

Zulvac 8 Bovis : EPAR - Product Information

Zulvac 8 Bovis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zulvac 8 Bovis
• 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
• Species:
  Cattle
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI02AA08

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of cattle from three months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.

Authorisation details

• EMA product number:
  EMEA/V/C/000145
• Marketing authorisation holder:
  Zoetis Belgium

  Zoetis Belgium; Rue Laid Burniat 1; 1348 Louvain-la-Neuve; Belgium

• Marketing authorisation issued:
  15/01/2010
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

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

Zulvac 8 Bovis-V-C-145-S-09 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/276757/2013

Zulvac 8 Bovis V-C-145-II-02 : EPAR - Scientific Discussion - Variation

Adopted Reference Number: EMA/249800/2011

Initial marketing authorisation documents

Zulvac 8 Bovis : EPAR - Procedural steps taken before authorisation

Zulvac 8 Bovis : EPAR - Scientific Discussion

Committee for medicinal products for veterinary use summary of opinion: Zulvac 8 Bovis: International Non-proprietary Names (INN): inactivated Bluetongue Virus (BTV) Serotype 8

Adopted Reference Number: EMEA/CVMP/665815/2008