Bluevac BTV8
bluetongue virus inactivated, serotype 8
Table of contents
Overview
This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Authorisation details
Product details | |
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Name |
Bluevac BTV8
|
Agency product number |
EMEA/V/C/000156
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Active substance |
bluetongue virus inactivated, serotype 8
|
International non-proprietary name (INN) or common name |
bluetongue virus inactivated, serotype 8
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Species |
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Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI04AA02
|
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. |
Publication details | |
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Marketing-authorisation holder |
CZ Veterinaria S.A.
|
Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
14/04/2011
|
Contact address |
Product information
16/02/2018 Bluevac BTV8 - EMEA/V/C/000156 - IB/0009
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
Active immunisation against bluetongue virus serotype 8 to prevent viraemia and to reduce clinical signs.
Onset of immunity: 20 days after second dose.
Duration of immunity: 1 year after second dose.
Cattle
Active immunisation against bluetongue virus serotype 8 to prevent viraemia.
Onset of immunity: 31 days after second dose.
Duration of immunity: 1 year after second dose.