Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: BTVPUR   
Auth. number : EU/2/10/113
Active substance : Bluetongue disease virus vaccine (containing either serotypes 1, 4 or 8) (inactivated)
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI02 - Immunologicals for bovidae
Pharmacological subgroup: QI02A - Cattle
Chemical subgroup: QI02AA - Inactivated viral vaccines
Chemical substance: QI02AA08 - bluetongue virus
(See WHO ATCvet Index)
Indication: Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of maximum 2 serotypes)
*(below the level of detection by the validated 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 for cattle and sheep is 1 year after primary vaccination course.
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, 69007 Lyon, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/12/2010 Centralised - Authorisation EMEA/V/C/2231 (2010)9519 of 17/12/2010
25/04/2012 Centralised - Annual reassessment EMEA/V/C/2231/S/1 (2012)2823 of 20/04/2012
13/05/2013 Centralised - Annual reassessment EMEA/V/C/2231/S/2 (2013)2780 of 06/05/2013
14/02/2014 Centralised - Variation EMEA/V/C/2231/IB/3
Updated with Decision(2015)1026 of 17/02/2015
19/02/2015 Centralised - Yearly update (2015)1026 of 17/02/2015
10/09/2015 Centralised - Renewal EMEA/V/C/2231/R/5 (2015)6266 of 08/09/2015
14/04/2016 Centralised - 2-Monthly update EMEA/V/C/2231/II/7/G (2016)2230 of 12/04/2016
16/02/2017 Centralised - Variation EMEA/V/C/2231/II/8
Updated with Decision(2018)2391 of 16/04/2018
18/04/2018 Centralised - Yearly update (2018)2391 of 16/04/2018