BTVPUR AlSap 1

RSS

bluetongue-virus serotype-1 antigen

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for BTVPUR AlSap 1 has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 17/05/2018

Authorisation details

Product details
Name
BTVPUR AlSap 1
Agency product number
EMEA/V/C/002230
Active substance
bluetongue-virus serotype-1 antigen
International non-proprietary name (INN) or common name
bluetongue-virus serotype-1 antigen
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI04AA02
Publication details
Marketing-authorisation holder
Merial
Revision
4
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

08/09/2015 BTVPUR AlSap 1 - EMEA/V/C/002230 - R/0005

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 serotype 1.

Onset of immunity has been demonstrated three weeks after the primary vaccination course. The duration of immunity for cattle and sheep is one year after the primary vaccination course.

Assessment history

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