Bovilis Blue-8
bluetongue virus vaccine (inactivated) serotype 8
Table of contents
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.
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 (inactivated) serotype 8
|
Species |
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI04AA02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Intervet International B.V.
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
21/11/2017
|
Contact address |
Wim de Körverstraat 35 |
Product information
10/12/2021 Bovilis Blue-8 - EMEA/V/C/004776 - IA/0005
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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)