BTVPUR

bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen 

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This is a summary of the European Public Assessment Report (EPAR) for BTVPUR. It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.

For practical information about using BTVPUR, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is BTVPUR and what is it used for?

BTVPUR is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.

The vaccine contains inactivated (killed) bluetongue virus. The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 4 or 8 or a combination of any two of these.

How is BTVPUR used?

The vaccine is available as a suspension for injection and can only be obtained with a prescription.

The vaccine is given to young animals as two injections under the skin. The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal’s mother is already immune to the disease. The second injection is given three to four weeks later. For a vaccine containing only bluetongue virus serotype 4 in sheep, one injection is sufficient.

How does BTVPUR work?

BTVPUR is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. BTVPUR contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to sheep and cattle, the animals’ immune systems recognise the viruses as ‘foreign’ and make antibodies against them. In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly. This will help to protect them against the disease.

BTVPUR contains bluetongue virus of one or two types selected from serotypes 1, 4 and 8. The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) that enhance the response of the immune system.

What benefits of BTVPUR have been shown in studies?

The effectiveness of the vaccine was studied in laboratory studies using vaccines containing bluetongue serotype 1, bluetongue serotype 8, or both, in sheep and cattle of young age. Further laboratory studies were conducted in sheep and calves using a vaccine containing bluetongue serotype 4. The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.

The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 1, 4 and 8.

The studies also showed that the vaccine can be used in pregnant and lactating sheep and cattle.

What are the risks associated with BTVPUR?

Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks. There can also be a slight rise in body temperature, usually of no more than 1 °C, in the 24 hours following vaccination.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat or milk used for human consumption. The withdrawal period for BTVPUR AlSap 1-8 for meat and milk for sheep and cattle is zero days, which means that there is no mandatory waiting time.

Why is BTVPUR approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that BTVPUR’s benefits are greater that its risks and recommended that it be approved for use in the EU.

BTVPUR is developed from AlSap 1-8 originally authorised under ‘exceptional circumstances’ on 17 December 2010 because limited information was available at the time of approval. As the company had supplied additional information requested, the ‘exceptional circumstances’ ended on 6 May 2013. In 2016 the CVMP considered that data submitted allowed BTVPUR AlSap 1-8 to convert to a BTVPUR vaccine based on three possible serotypes with one or two serotypes selected depending on the need.

Other information about BTVPUR

The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR on 12 April 2016.

For more information about treatment with BTVPUR, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

 

Name Language First published Last updated
BTVPUR : EPAR - Summary for the public BG = bălgarski 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public ES = español 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public CS = čeština 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public DA = dansk 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public DE = Deutsch 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public ET = eesti keel 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public EL = elliniká 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public EN = English 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public FR = français 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public IT = italiano 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public LV = latviešu valoda 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public LT = lietuvių kalba 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public HU = magyar 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public MT = Malti 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public NL = Nederlands 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public PL = polski 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public PT = português 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public RO = română 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public SK = slovenčina 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public SL = slovenščina 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public FI = suomi 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public SV = svenska 2011-01-03 2016-06-22
BTVPUR : EPAR - Summary for the public HR = Hrvatski 2011-01-03 2016-06-22

This EPAR was last updated on 22/06/2016 .

Authorisation details

Product details

Product details for BTVPUR
NameBTVPUR
Agency product numberEMEA/V/C/002231
Active substance

bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen 

International non-proprietary name (INN) or common name

bluetongue vaccine (inactivated) (multistrain:1-2 strains out of a set of 3)

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codeQI04AA02

Publication details

Publication details for BTVPUR
Marketing-authorisation holder

Merial

Revision5
Date of issue of marketing authorisation valid throughout the European Union17/12/2010

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

12/04/2016  BTVPUR -EMEA/V/C/002231 -II/0007/G

Name Language First published Last updated
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - Product Information HR = Hrvatski 2011-01-03 2016-06-22

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
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22
BTVPUR : EPAR - All Authorised presentations HR = Hrvatski 2011-01-03 2016-06-22

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 1, 4 and/ or 8 (combination of maximum 2 serotypes) *(below the level of detection by the validation RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission).

Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. The duration of immunity is not yet established in cattle or sheep.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
BTVPUR AlSap 1-8 : EPAR - Scientific Discussion HR = Hrvatski 2011-01-03  
CVMP summary of positive opinion for BTVPUR AlSap 1-8 HR = Hrvatski 2010-10-15  

Authorised

This medicine is approved for use in the European Union

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