Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Bovilis BTV8   
Auth. number : EU/2/10/106
INN : Bluetongue Virus Serotype 8
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: Sheep
To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia* to a level that prevents the transmission of infective virus.
*(cycling value (Ct) >30 by a validated rRT-PCR method, indicating absence of infectious virus)
Cattle
To stimulate active immunity in calves from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia.
Marketing Authorisation Holder: Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

  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
08/09/2010 Centralised - Authorisation EMEA/V/C/148 (2010)6233 of 06/09/2010
19/12/2011 Centralised - Variation EMEA/V/C/148/IB/1
Updated with Decision(2012)4510 of 27/06/2012
12/01/2012 Centralised - Annual reassessment EMEA/V/C/148/S/2
02/07/2012 Centralised - Variation (2012)4510 of 27/06/2012
12/09/2012 Corrigendum (2012)7154 of 08/10/2012
16/01/2013 Centralised - Annual reassessment EMEA/V/C/148/S/4 (2013)126 of 14/01/2013
18/03/2014 Centralised - Variation EMEA/V/C/148/S/5 (2014)1864 of 14/03/2014