Zulvac 1 Bovis

Withdrawn

This medicine's authorisation has been withdrawn

inactivated bluetongue virus, serotype 1

Overview

The marketing authorisation for Zulvac 1 Bovis has been withdrawn at the request of the marketing authorisation holder.

Zulvac 1 Bovis : EPAR - Summary for the public

Reference Number: EMA/457915/2011

Product information

Zulvac 1 Bovis : EPAR - Product information

Zulvac 1 Bovis : EPAR - All authorised presentations

Product details

• Name of medicine:
  Zulvac 1 Bovis
• Active substance:
  inactivated bluetongue virus, serotype 1
• International non-proprietary name (INN) or common name:
  inactivated bluetongue virus, serotype 1
• Species:
  Cattle
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI02AA08

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of cattle from 2½ months of age for the prevention of viraemia caused by bluetongue virus, serotype 1.

Onset of immunity: 15 days after completion of the primary vaccination course.

Duration of immunity: 12 months.

Authorisation details

• EMA product number:
  EMEA/V/C/002334
• 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.

• Marketing authorisation holder:
  Zoetis Belgium SA

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

• Marketing authorisation issued:
  05/08/2011
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

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

Zulvac 1 Bovis-V-C-2334-S-02 : EPAR - Assessment Report - Annual re-assessment

Adopted Reference Number: EMA/119947/2013

Initial marketing authorisation documents

Zulvac 1 Bovis : EPAR - Scientific discussion

Reference Number: EMA/457917/2011

CVMP summary of positive opinion for Zulvac 1 Bovis

Adopted Reference Number: EMA/CVMP/506555/2010