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 21/12/2017

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
3
Date of issue of marketing authorisation valid throughout the European Union
22/12/2014
Contact address
Binger Str. 73
55216 Ingelheim am Rhein
Germany

Product information

08/12/2017 Bovela - EMEA/V/C/003703 - IB/0010

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

  • 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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