Bovilis BTV8

RSS

bluetongue virus serotype 8

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

Overview

This is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 06/07/2015

Authorisation details

Product details
Name
Bovilis BTV8
Agency product number
EMEA/V/C/000148
Active substance
inactivated bluetongue virus, serotype 8, in culture medium
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

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Immunologicals for sheep
  • Inactivated viral vaccines
  • bluetongue virus

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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