Bluevac BTV8

RSS

bluetongue virus inactivated, serotype 8

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

Overview

This document 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 document 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 06/03/2018

Authorisation details

Product details
Name
Bluevac BTV8
Agency product number
EMEA/V/C/000156
Active substance
bluetongue virus inactivated, serotype 8
International non-proprietary name (INN) or common name
bluetongue virus inactivated, serotype 8
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI04AA02
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.

Publication details
Marketing-authorisation holder
CZ Veterinaria S.A.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
13/04/2011
Contact address
La Relva s/n
36400 Porriño (Pontevedra)
Spain

Product information

15/02/2018 Bluevac BTV8 - EMEA/V/C/000156 - IB/0009

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

Therapeutic indication

Sheep

Active immunisation against bluetongue virus serotype 8 to prevent viraemia and to reduce clinical signs.

Onset of immunity: 20 days after second dose.

Duration of immunity: 1 year after second dose.

Cattle

Active immunisation against bluetongue virus serotype 8 to prevent viraemia.

Onset of immunity: 31 days after second dose.

Duration of immunity: 1 year after second dose.

Assessment history

How useful was this page?

Add your rating