Zulvac 1 Ovis

Withdrawn

This medicine's authorisation has been withdrawn

inactivated bluetongue virus, serotype-1

Overview

The marketing authorisation for Zulvac 1 Ovis has been withdrawn at the request of the marketing-authorisation holder.

Zulvac 1 Ovis : EPAR - Summary for the public

Product information

Zulvac 1 Ovis : EPAR - Product information

Zulvac 1 Ovis : EPAR - All authorised presentations

Product details

• Name of medicine:
  Zulvac 1 Ovis
• Active substance:
  inactivated bluetongue virus, serotype-1
• International non-proprietary name (INN) or common name:
  inactivated bluetongue virus, serotype-1
• Species:
  Sheep
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI04AA02

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by bluetongue virus, serotypes-1.

Onset of immunity: 21 days after completion of the primary vaccination scheme.

Duration of immunity: 12 months.

Authorisation details

• EMA product number:
  EMEA/V/C/002335
• 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:
  6

Assessment history

Changes since initial authorisation of medicine

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

Zulvac 1 Ovis-V-C-2335-S-03 : EPAR - Assessment Report - Annual re-assessment

Adopted Reference Number: EMA/120064/2013

Initial marketing authorisation documents

Zulvac 1 Ovis : EPAR - Scientific discussion

Reference Number: EMA/457946/2011

CVMP summary of positive opinion for Zulvac 1 Ovis

Adopted Reference Number: EMA/CVMP/291025/2011