Bovela
bovine viral diarrhoea vaccine (modified live)
Table of contents
Overview
This 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 summary 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 |
Bovela
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Agency product number |
EMEA/V/C/003703
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Active substance |
modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93
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International non-proprietary name (INN) or common name |
bovine viral diarrhoea vaccine (modified live)
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Anatomical therapeutic chemical veterinary (ATCvet) codes |
QI02AD02
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Publication details | |
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Marketing-authorisation holder |
Boehringer Ingelheim Vetmedica GmbH
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
22/12/2014
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Contact address |
Binger Strasse 173 |
Product information
11/11/2019 Bovela - EMEA/V/C/003703 - R/0014
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
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Immunologicals for bovidae
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Live viral vaccines
Therapeutic indication
For active immunisation of cattle from 3 months of age to reduce hyperthermia and to minimise the reduction of leukocyte count caused by bovine viral diarrhoea virus (BVDV-1 and BVDV-2), and to reduce virus shedding and viraemia caused by BVDV-2.
For active immunisation of cattle against BVDV-1 and BVDV-2, to prevent the birth of persistently infected calves caused by transplacental infection.