Bovilis BTV8

RSS

bluetongue virus serotype 8

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 27/07/2022

Authorisation details

Product details
Name
Bovilis BTV8
Agency product number
EMEA/V/C/000148
Active substance
bluetongue virus vaccine, serotype 8 (inactivated)
International non-proprietary name (INN) or common name
bluetongue virus serotype 8
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI04AA02
Publication details
Marketing-authorisation holder
Intervet International BV
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
06/09/2010
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

05/06/2015 Bovilis BTV8 - EMEA/V/C/000148 - R/0007

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Inactivated viral vaccines
  • bluetongue virus
  • SHEEP

Therapeutic indication

Cattle

To stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia

Sheep

To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia

Assessment history

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