Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Zulvac 8 Ovis   
Auth. number : EU/2/09/104
INN : Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
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 from 1.5 months of age for the prevention of viraemia caused by Bluetongue Virus, serotype 8.
Marketing Authorisation Holder: Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

  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
19/01/2010 Centralised - Authorisation EMEA/V/C/147 (2010)187 of 15/01/2010
20/08/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/147/T/2 (2010)5851 of 18/08/2010
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/147/WS/1
26/01/2011 Centralised - Variation EMEA/V/C/147/II/1 (2011)414 of 21/01/2011
25/05/2011 Centralised - Annual reassessment EMEA/V/C/147/S/3
15/11/2011 Centralised - Variation (2011)8234 of 10/11/2011
15/11/2011 Centralised - Variation EMEA/V/C/147/IA/6/G
Updated with Decision(2011)8234 of 10/11/2011
11/08/2012 Centralised - Annual reassessment EMEA/V/C/147/S/8
22/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/147/T/11 (2013)2990 of 16/05/2013
19/06/2013 Centralised - Variation EMEA/V/C/147/IG/258/12
Updated with Decision(2014)4498 of 27/06/2014
05/09/2013 Centralised - Variation EMEA/V/C/147/IG/330/13/G
Updated with Decision(2014)4498 of 27/06/2014
17/09/2013 Centralised - Annual reassessment EMEA/V/C/147/S/9 (2013)5968 of 13/09/2013
01/07/2014 Centralised - Yearly update (2014)4498 of 27/06/2014
12/11/2014 Centralised - Renewal EMEA/V/C/147/R/16 (2014)8416 of 07/11/2014