Bluevac BTV (previously Bluevac BTV8)

Authorised

This medicine is authorised for use in the European Union

Overview

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

Bluevac BTV : EPAR - Medicine overview

Product information

Bluevac BTV : EPAR - Product Information

Bluevac BTV : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Bluevac BTV (previously Bluevac BTV8)
• Active substance:
  bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated]

Pharmacotherapeutic group

• Immunologicals for Ovidae
• Immunologicals for Bovidae
• Inactivated viral vaccines

Authorisation details

• EMA product number:
  EMEA/V/C/000156
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Assessment history

Changes since initial authorisation of medicine

Bluevac BTV : EPAR - Procedural steps taken and scientific information after authorisation

CVMP post-authorisation summary of positive opinion for Bluevac BTV (EMA/VRA/0000293372)

Adopted Reference Number: EMADOC-1700519818-2907706

CVMP post-authorisation summary of positive opinion for Bluevac BTV

Adopted Reference Number: EMAVRA0000255727

CVMP post-authorisation summary of positive opinion for Bluevac BTV (VRA-0012-G)

Adopted Reference Number: EMA/CVMP/183632/2024

Bluevac BTV-V-C-000156-II-0010-G : EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Bluevac BTV

Adopted Reference Number: EMA/CVMP/307513/2020

Initial marketing authorisation documents

Bluevac BTV8 : EPAR - Scientific Discussion

CVMP summary of positive opinion for Bluevac BTV8

Adopted Reference Number: EMA/CVMP/343772/2010