Bovilis Blue-8

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bluetongue virus vaccine, serotype 8 (inactivated)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Bovilis Blue-8.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Bovilis Blue-8.

For practical information about using Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

This EPAR was last updated on 26/07/2018

Authorisation details

Product details
Name
Bovilis Blue-8
Agency product number
EMEA/V/C/004776
Active substance
bluetongue virus vaccine, serotype 8 (inactivated)
International non-proprietary name (INN) or common name
bluetongue virus vaccine, serotype 8 (inactivated)
Species
  • Cattle
  • Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI04AA02
Publication details
Marketing-authorisation holder
Intervet International B.V.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
21/11/2017
Contact address
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

23/07/2018 Bovilis Blue-8 - EMEA/V/C/004776 - IAIN/0001

Contents

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Pharmacotherapeutic group

IMMUNOLOGICALS FOR OVIDAE

Therapeutic indication

Sheep

For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.

Cattle

For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.

*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)

Assessment history

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