BTVPUR Alsap 8

RSS

adjuvanted bluetongue virus vaccine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for BTVPUR AlSap 8 has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 16/05/2018

Authorisation details

Product details
Name
BTVPUR Alsap 8
Agency product number
EMEA/V/C/000146
Active substance
bluetongue virus serotype 8 antigen
International non-proprietary name (INN) or common name
adjuvanted bluetongue virus vaccine
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AA08
Publication details
Marketing-authorisation holder
Merial
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
17/03/2009
Contact address
29 avenue Tony Garnier
69007 Lyon
France

Product information

12/03/2014 BTVPUR Alsap 8 - EMEA/V/C/000146 - R/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 FOR OVIDAE
  • IMMUNOLOGICALS FOR BOVIDAE

Therapeutic indication

Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission).

Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.

The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.

The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.

Assessment history

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