BTVPUR

Authorised

This medicine is authorised for use in the European Union

inactivated vaccine against bluetongue virus serotypes 1 and 8

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

BTVPUR : EPAR - Medicine overview

Product information

BTVPUR : EPAR - Product Information

BTVPUR : EPAR - All Authorised presentations

Product details

• Name of medicine:
  BTVPUR
• Active substance:
  • bluetongue-virus serotype-1 antigen
  • bluetongue virus serotype 8 antigen
• International non-proprietary name (INN) or common name:
  inactivated vaccine against bluetongue virus serotypes 1 and 8

Authorisation details

• EMA product number:
  EMEA/V/C/002231

Assessment history

Changes since initial authorisation of medicine

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

CVMP post-authorisation summary of positive opinion for BTVPUR (VRA/0000322270)

Adopted Reference Number: EMADOC-1700519818-3149659

BTVPUR-V-C-2231-II-0010 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/427355/2018

BTVPUR-V-C-2231-II-0007-G : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/145479/2016

CVMP post-authorisation summary of positive opinion for BTVPUR AlSap 1-8

Adopted Reference Number: EMEA/CVMP/66986/2016

BTVPUR AlSap 1-8-V-C-2231-S-0002 : EPAR - Annual re-assessment report

Adopted Reference Number: EMA/136808/2013

Initial marketing authorisation documents

BTVPUR AlSap 1-8 : EPAR - Scientific Discussion

Reference Number: EMA/CVMP/622534/2010

CVMP summary of positive opinion for BTVPUR AlSap 1-8

Adopted Reference Number: EMA/CVMP/343726/2010