Bovilis BTV8

inactivated bluetongue virus, serotype 8, in culture medium

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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 Bovilis BTV8?

Bovilis BTV8 is a vaccine that contains an inactivated (killed) bluetongue serotype 8 virus as the active substance. It is available as a suspension for injection.

What is Bovilis BTV8 used for?

Bovilis BTV8is used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. The virus exists in several forms (serotypes) throughout the world; the type used in Bovilis BTV8 is serotype 8. The vaccine is used to prevent viraemia (the presence of viruses in the blood) in sheep and to limit viraemia in cattle.

The vaccine is given to young animals as an injection under the skin. One injection is enough to vaccinate sheep, but cattle will need a second injection approximately three weeks later. The first injection is given from one month of age in sheep and from six weeks of age in cattle.

How does Bovilis BTV8 work?

Bovilis BTV8 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Bovilis BTV8 contains bluetongue virus that has been inactivated so that it cannot cause the disease. When it is given to cattle and sheep, the animals’ immune system recognises the virus as ‘foreign’ and produce antibodies against it. In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly. This will help to protect against the disease.

The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to enhance the immune response.

How has Bovilis BTV8 been studied?

The safety of the vaccine was studied in laboratory safety studies carried out with an overdose of Bovilis BTV8 in young lambs and calves and in pregnant ewes and cows.

The efficacy of the vaccine in cattle and sheep was studied in a number of laboratory trials; in cattle from six weeks of age and in sheep from one month of age.. The main measure of effectiveness was the level of the bluetongue virus in the blood (viraemia) of animals. In all studies the vaccinated cattle and sheep were compared with animals that were not immunised (controls). The risk of bluetongue transmission to cattle following vaccination with Bovilis BTV8 was further investigated in two epidemiological models.

What benefit has Bovilis BTV8 shown during the studies?

The studies showed that the vaccine is safe for both sheep and cattle and that it prevents viraemia in sheep from one month of age when infected with bluetongue virus serotype 8, whereas Bovilis BTV8 reduces viraemia in cattle from six weeks of age.

Bovilis BTV8 was shown to be safe for use in pregnant ewes and cattle.

What is the risk associated with Bovilis BTV8?

After vaccination, animals may have a slightly raised temperature (usually not more than 0.5°C, but in individual cases up to about 2°C) for up to three days after vaccination. There can also be a temporary swelling at the injection site, lasting for up to three weeks in sheep and six weeks in cattle. Some animals may also have hypersensitivity (allergic) reactions.

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 or milk used for human consumption.

The withdrawal period for both sheep and cattle for meat and milk is zero days.

Why has Bovilis BTV8 been approved?

The CVMP concluded that the benefits of Bovilis BTV8 exceed the risks and recommended that Bovilis BTV8 be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Bovilis BTV8 was initially authorised under ‘exceptional circumstances’. This means that it was not possible at the time of the initial authorisation to obtain complete information about Bovilis BTV8. The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine.

Other information about Bovilis BTV8

The European Commission granted a marketing authorisation valid throughout the European Union, for Bovilis BTV8 on 06/09/2010. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Bovilis BTV8 : EPAR - Summary for the public BG = bălgarski 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public ES = español 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public CS = čeština 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public DA = dansk 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public DE = Deutsch 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public ET = eesti keel 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public EL = elliniká 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public EN = English 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public FR = français 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public IT = italiano 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public LV = latviešu valoda 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public LT = lietuvių kalba 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public HU = magyar 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public MT = Malti 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public NL = Nederlands 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public PL = polski 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public PT = português 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public RO = română 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public SK = slovenčina 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public SL = slovenščina 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public FI = suomi 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public SV = svenska 2010-09-09 2014-07-16
Bovilis BTV8 : EPAR - Summary for the public HR = Hrvatski 2010-09-09 2014-07-16

This EPAR was last updated on 06/07/2015 .

Authorisation details

Product details

Product details for Bovilis BTV8
NameBovilis BTV8
Agency product numberEMEA/V/C/000148
Active substance

inactivated bluetongue virus, serotype 8, in culture medium

International non-proprietary name (INN) or common name

bluetongue virus serotype 8

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQI04AA02

Publication details

Publication details for Bovilis BTV8
Marketing-authorisation holder

Intervet International BV

Revision4
Date of issue of marketing authorisation valid throughout the European Union06/09/2010

Contact address:

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

05/06/2015  Bovilis BTV8 -EMEA/V/C/000148 -R/0007

Name Language First published Last updated
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06
Bovilis BTV8 : EPAR - Product Information HR = Hrvatski 2010-09-09 2015-07-06

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
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - All Authorised presentations HR = Hrvatski 2010-09-09  

Pharmacotherapeutic group

Immunologicals for sheep, inactivated viral vaccines, bluetongue virus

Therapeutic indication

Cattle

To stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia

Sheep

To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Bovilis BTV8 : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2011-12-14 2015-07-06
Bovilis BTV8 : EPAR - Assessment Report - Variation HR = Hrvatski 2014-07-16  

Initial marketing-authorisation documents

Name Language First published Last updated
Bovilis BTV8 : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2010-09-09  
Bovilis BTV8 : EPAR - Scientific Discussion HR = Hrvatski 2010-09-09  
CVMP summary of positive opinion for Bovilis BTV8 HR = Hrvatski 2010-06-18