BTVPUR

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bluetongue vaccine (inactivated) (multistrain:1-2 strains out of a set of 3)

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

Overview

BTVPUR 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 is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.

The vaccine contains inactivated (killed) bluetongue virus. The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 2, 4 or 8 or a combination of any two of these.

This EPAR was last updated on 18/10/2018

Authorisation details

Product details
Name
BTVPUR
Agency product number
EMEA/V/C/002231
Active substance
bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen 
International non-proprietary name (INN) or common name
bluetongue vaccine (inactivated) (multistrain:1-2 strains out of a set of 3)
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
  • QI04AA02
  • QI02AA08
Publication details
Marketing-authorisation holder
Merial
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
17/12/2010
Contact address
29 avenue Tony Garnier
69007 Lyon
France

Product information

20/08/2018 BTVPUR - EMEA/V/C/002231 - II/0010

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

Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/ or 8 (combination of maximum 2 serotypes), Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1,2, 4 and/ or 8 ( combination of maximum 2 serotypes), Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).

Active immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes). and Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).

Active immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes).

Assessment history

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