Bovela

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bovine viral diarrhoea vaccine (modified live)

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

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).

This EPAR was last updated on 27/11/2019

Authorisation details

Product details
Name
Bovela
Agency product number
EMEA/V/C/003703
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
International non-proprietary name (INN) or common name
bovine viral diarrhoea vaccine (modified live)
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI02AD02
Publication details
Marketing-authorisation holder
Boehringer Ingelheim Vetmedica GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/12/2014
Contact address

Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Product information

11/11/2019 Bovela - EMEA/V/C/003703 - R/0014

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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 bovidae
  • 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.

Assessment history

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