BTVPUR AlSap 2-4

Withdrawn

This medicine's authorisation has been withdrawn

inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections

Overview

The marketing authorisation for this product has been withdrawn due to the application of the sunset clause.

BTVPUR AlSap 2-4 : EPAR - Summary for the public

Reference Number: EMA/CVMP/343593/2010

Product information

BTVPUR AlSap 2-4 : EPAR - Product Information

BTVPUR AlSap 2-4 : EPAR - All Authorised presentations

Product details

• Name of medicine:
  BTVPUR AlSap 2-4
• Active substance:
  • bluetongue-virus serotype-2 antigen
  • bluetongue-virus serotype-4 antigen
• International non-proprietary name (INN) or common name:
  inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections
• Species:
  Sheep
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI04AA02

Pharmacotherapeutic group

• bluetongue virus
• Inactivated viral vaccines
• Immunologicals for Ovidae

Therapeutic indication

Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.

Authorisation details

• EMA product number:
  EMEA/V/C/000139
• Marketing authorisation holder:
  Mérial

  29 avenue Tony Garnier; 69007 Lyon; France

• Marketing authorisation issued:
  04/11/2010
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

BTVPUR AlSap 2-4 : EPAR - Procedural steps taken and scientific information after authorisation

BTVPUR AlSap 2-4-V-C-139-S-0004 : EPAR - Assessment Report - Annual re-assessment

Adopted Reference Number: EMA/132659/2014

Initial marketing authorisation documents

BTVPUR AlSap 2-4 : EPAR - Scientific Discussion

Reference Number: EMA/CVMP/343595/2010

BTVPUR AlSap 2-4 : EPAR - Procedural steps taken before authorisation

CVMP summary of positive opinion for BTVPUR AlSap 2-4

Adopted Reference Number: EMA/CVMP/256124/2010