Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Zulvac 1 Ovis   
Auth. number : EU/2/11/131
INN : Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI04 - Immunologicals for ovidae
Pharmacological subgroup: QI04A - Sheep
Chemical subgroup: QI04AA - Inactivated viral vaccines
Chemical substance: QI04AA02 - 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 1.
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
10/08/2011 Centralised - Authorisation EMEA/V/C/2235 (2011)5822 of 05/08/2011
13/12/2011 Centralised - Variation EMEA/V/C/2235/IB/WS/5 (2011)9435 of 09/12/2011
22/02/2013 Centralised - Annual reassessment EMEA/V/C/2235/S/3 (2013)1097 of 20/02/2013
22/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/2335/T/5 (2013)2989 of 16/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/2335/IG/330/6/G
Updated with Decision(2014)6469 of 09/09/2014