Bovela

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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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).

What is Bovela?

Bovela is a veterinary vaccine that contains two types of a modified live bovine viral diarrhoea (BVD) virus (BVDV-1 and BVDV-2). It is available as a lyophilisate (freeze dried powder) and solvent for injection.

What is Bovela used for?

Bovela is used to protect cattle against BVD viral infection. In non-pregnant animals the infection is generally mild, with signs affecting the airways such as cough, and reduced milk yield. However a severe form of BVD can occur, when cattle have a high temperature and bloody diarrhoea. In pregnant cows, BVD infection can cause abortions or result in the birth of calves that are persistently infected (PI). PI animals tend never to reach their productive potential, have reduced fertility and are more susceptible to other diseases. They may progress to have mucosal disease which is another form of BVD disease with ulcers and blisters on the snout and inside of the mouth. Mucosal disease is usually fatal. PI animals are a constant source of BVD virus, infecting other cattle in the herd.

The vaccine is given to cattle as a single injection into the muscle. Protection starts three weeks after vaccination and lasts for one year. To prevent the birth of a PI calf the vaccine should be given at least three weeks before insemination/mating.

How does Bovela work?

Bovela is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Bovela contains two BVDV strains (or types) modified by deletion of parts of two genes so that they can no longer cause disease. When Bovela is given to cattle the animals’ immune system recognises the virus strains as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to the virus the immune system will be able to respond more quickly. This will help protect the cattle against BVD infections.

How has Bovela been studied?

The effectiveness of the vaccine was first studied in a number of laboratory studies in cattle. The purpose of the studies was to establish how long it took for cattle to be fully protected, the length of time protection against BVD lasts, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine in calves.

The effectiveness of Bovela was further investigated in the field in eight dairy cattle herds of which five of them had a history of BVD or persistent infection at the beginning of the study. Approximately half of the cattle were vaccinated with Bovela and the rest received a dummy injection. The main measure of effectiveness was the reduction in the number of persistently infected newborn calves as determined by virus specific identification tests.

What benefit has Bovela shown during the studies?

In the laboratory studies Bovela prevented PI in 100% of calves while the animals that received no vaccination gave birth to 100% PI calves.

In the field study 98.5% of vaccinated cattle sampled (range 269–274 animals) developed antibodies to both BVD virus types. In the group vaccinated with Bovela five out of 1,216 (0.4%) newborn calves were persistently infected with the virus, whereas in the group given the dummy injection there were ten persistently infected newborn calves out of 1,183 born (0.8%). However, for the vaccinated group the period of infection was either before vaccination or before the start of protection.

What is the risk associated with Bovela?

The most common side effect (seen in more than 1 in 100 cattle) was an increase in body temperature (within the normal range) within four hours of vaccination, which spontaneously resolves within 24 hours.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.

What is the withdrawal period?

The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.The withdrawal period for Bovela for cattle is zero days.

Why has Bovela been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Bovela exceed the risks for the approved indication and recommended that Bovela be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Bovela

The European Commission granted a marketing authorisation valid throughout the European Union, for Bovela on 22 December 2014. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Bovela : EPAR - Summary for the public BG = bălgarski 2015-02-17  
Bovela : EPAR - Summary for the public ES = español 2015-02-17  
Bovela : EPAR - Summary for the public CS = čeština 2015-02-17  
Bovela : EPAR - Summary for the public DA = dansk 2015-02-17  
Bovela : EPAR - Summary for the public DE = Deutsch 2015-02-17  
Bovela : EPAR - Summary for the public ET = eesti keel 2015-02-17  
Bovela : EPAR - Summary for the public EL = elliniká 2015-02-17  
Bovela : EPAR - Summary for the public EN = English 2015-02-17  
Bovela : EPAR - Summary for the public FR = français 2015-02-17  
Bovela : EPAR - Summary for the public IT = italiano 2015-02-17  
Bovela : EPAR - Summary for the public LV = latviešu valoda 2015-02-17  
Bovela : EPAR - Summary for the public LT = lietuvių kalba 2015-02-17  
Bovela : EPAR - Summary for the public HU = magyar 2015-02-17  
Bovela : EPAR - Summary for the public MT = Malti 2015-02-17  
Bovela : EPAR - Summary for the public NL = Nederlands 2015-02-17  
Bovela : EPAR - Summary for the public PL = polski 2015-02-17  
Bovela : EPAR - Summary for the public PT = português 2015-02-17  
Bovela : EPAR - Summary for the public RO = română 2015-02-17  
Bovela : EPAR - Summary for the public SK = slovenčina 2015-02-17  
Bovela : EPAR - Summary for the public SL = slovenščina 2015-02-17  
Bovela : EPAR - Summary for the public FI = suomi 2015-02-17  
Bovela : EPAR - Summary for the public SV = svenska 2015-02-17  
Bovela : EPAR - Summary for the public HR = Hrvatski 2015-02-17  

This EPAR was last updated on 13/10/2016 .

Authorisation details

Product details

Product details for Bovela
NameBovela
Agency product numberEMEA/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)

Species
Anatomical therapeutic chemical veterinary (ATCvet) codeQI02AD02

Publication details

Publication details for Bovela
Marketing-authorisation holder

Boehringer Ingelheim Vetmedica GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union22/12/2014

Contact address:

Boehringer Ingelheim Vetmedica GmbH
Binger Str. 73
55216 Ingelheim am Rhein
Germany

Product information

Product information

27/09/2016  Bovela -EMEA/V/C/003703 -IG/0722

Name Language First published Last updated
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13
Bovela : EPAR - Product Information HR = Hrvatski 2015-02-17 2016-10-13

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.


Name Language First published Last updated
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  
Bovela : EPAR - All Authorised presentations HR = Hrvatski 2015-02-17  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Bovela : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-10-13  

Initial marketing-authorisation documents

Name Language First published Last updated
Bovela : EPAR - Public assessment report HR = Hrvatski 2015-02-17  
CVMP summary of positive opinion for Bovela HR = Hrvatski 2014-10-10