Pharmaceuticals - Community Register


Community list of not active veterinary medicinal products


Product information

Invented name: BTVPUR AlSap 1
Auth. number : EU/2/10/112
Active substance : Bluetongue Virus Serotype 1 antigen
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 serotype 1.
*(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 the 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/2230 (2010)9518 of 17/12/2010
25/04/2012 Centralised - Annual reassessment EMEA/V/C/2230/S/1 (2012)2822 of 20/04/2012
13/05/2013 Centralised - Annual reassessment EMEA/V/C/2230/S/2 (2013)2781 of 06/05/2013
14/02/2014 Centralised - Variation EMEA/V/C/2230/IB/3
Updated with Decision(2015)1025 of 17/02/2015
19/02/2015 Centralised - Yearly update (2015)1025 of 17/02/2015
10/09/2015 Centralised - Renewal EMEA/V/C/2230/R/5 (2015)6265 of 08/09/2015
16/05/2018 Centralised - Withdrawal (2018)3017 of 08/05/2018