BTVPUR AlSap 1

Withdrawn

This medicine's authorisation has been withdrawn

bluetongue-virus serotype-1 antigen

Overview

Introduction

The marketing authorisation for BTVPUR AlSap 1 has been withdrawn at the request of the marketing-authorisation holder.

BTVPUR AlSap 1 : EPAR - Summary for the public

Reference Number: EMA/CVMP/622300/2010

Product information

BTVPUR AlSap 1 : EPAR - Product Information

Reference Number: EMA/CVMP/622300/2010

BTVPUR AlSap 1 : EPAR - All Authorised presentations

Reference Number: EMA/CVMP/622300/2010

Product details

• Name of medicine:
  BTVPUR AlSap 1
• 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) code:
  QI04AA02

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.

Authorisation details

• EMA product number:
  EMEA/V/C/002230
• Marketing authorisation holder:
  Merial

  29 Avenue Tony Garnier; 69007 Lyon; France

• Marketing authorisation issued:
  17/12/2010
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

BTVPUR AlSap 1 : EPAR - Procedural steps taken and scientific information after authorisation

BTVPUR AlSap 1-V-C-2230-S-02 : EPAR - Assessment Report - Annual re-assessment

Adopted Reference Number: EMA/136739/2013

Initial marketing authorisation documents

BTVPUR AlSap 1 : EPAR - Scientific Discussion

Reference Number: EMA/CVMP/622300/2010

CVMP summary of positive opinion for BTVPUR AlSap 1

Adopted Reference Number: EMA/CVMP/343642/2010