Zulvac BTV

RSS

Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)

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

Overview

Zulvac BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.

The vaccine contains inactivated (killed) bluetongue virus. When used in sheep the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8.When used in cattle the vaccine contains either BTV serotype 1 or BTV serotype 8. The serotype to be used in the vaccine is selected before manufacture depending on which type is circulating and causing disease at the time. The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.

This EPAR was last updated on 19/03/2019

Authorisation details

Product details
Name
Zulvac BTV
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 virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AA
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
1
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

21/02/2019 Zulvac BTV - EMEA/V/C/004185 - X/0001

Contents

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Pharmacotherapeutic group

  • Immunologicals
  • Immunologicals for bovidae
  • Immunologicals for sheep
  • Inactivated viral vaccines
  • bluetongue virus

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 and active immunisation of cattle from 12 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8.

Assessment history

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