Zulvac BTV Ovis

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bluetongue vaccine (inactivated)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Zulvac BTV Ovis. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Zulvac BTV Ovis.

For practical information about using Zulvac BTV Ovis, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 12/05/2017

Authorisation details

Product details
Name
Zulvac BTV Ovis
Agency product number
EMEA/V/C/004185
Active substance
One of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
International non-proprietary name (INN) or common name
bluetongue vaccine (inactivated)
Species
Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI04AA02
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
25/04/2017
Contact address
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Product information

25/04/2017 Zulvac BTV Ovis - EMEA/V/C/004185 -

Contents

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Pharmacotherapeutic group

  • Immunologicals

  • inactivated viral vaccines for sheep

Therapeutic indication

Active immunisation of sheep from 6 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8, and for the reduction of viraemia caused by bluetongue virus, serotype 4.

Assessment history

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