Bovilis Blue-8
bluetongue virus vaccine, serotype 8 (inactivated)
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, serotype 8 (inactivated)
|
Species |
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI04AA02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Intervet International B.V.
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
21/11/2017
|
Contact address |
Product information
15/01/2019 Bovilis Blue-8 - EMEA/V/C/004776 - IAIN/0003
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
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)