Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: BTVPUR AlSap 8   
Auth. number : EU/2/09/094
INN : Bluetongue virus Serotype 8 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 8.*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml)
Marketing Authorisation Holder: Merial
29 avenue Tony Garnier, F-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 continues to be 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
19/03/2009 Centralised - Authorisation EMEA/V/C/146 (2009)2065 of 17/03/2009
28/09/2009 Centralised - Variation EMEA/V/C/146/II/2
28/12/2009 Corrigendum (2009)2065 corr of 22/12/2009
14/01/2010 Centralised - Variation EMEA/V/C/146/II/1 (2010)120 of 12/01/2010
28/04/2010 Centralised - Annual reassessment EMEA/V/C/146/S/3
10/09/2010 Centralised - Variation EMEA/V/C/146/IB/4
Updated with Decision(2011)2253 of 28/03/2011
31/03/2011 Centralised - Variation (2011)2253 of 28/03/2011
11/05/2011 Centralised - Annual reassessment EMEA/V/C/146/S/5
19/08/2011 Centralised - Variation EMEA/V/C/146/IB/6
Updated with Decision(2012)1855 of 15/03/2012
19/03/2012 Centralised - Variation (2012)1855 of 15/03/2012
05/09/2012 Centralised - Variation EMEA/V/C/146/S/8 (2012)6192 of 03/09/2012
14/03/2014 Centralised - Renewal EMEA/V/C/146/R/10 (2014)1736 of 12/03/2014