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Community register of veterinary medicinal products


Product information

Invented name: Zulvac 1 Bovis   
Auth. number : EU/2/11/130
Active substance : Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 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 cattle from 2 ½ months of age for the prevention of viraemia caused by Bluetongue Virus (BTV), 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/2334 (2011)5821 of 05/08/2011
19/12/2011 Centralised - Variation EMEA/V/C/2334/IB/WS/5 (2011)9752 of 14/12/2011
22/02/2013 Centralised - Annual reassessment EMEA/V/C/2334/S/2 (2013)1098 of 20/02/2013
24/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/2334/T/4 (2013)3100 of 22/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/2334
Updated with Decision(2014)6468 of 09/09/2014
11/09/2014 Centralised - Yearly update (2014)6468 of 09/09/2014
20/04/2016 Centralised - Renewal EMEA/V/C/2334/R/10 (2016)2431 of 18/04/2016
23/03/2017 Centralised - Variation EMEA/V/C/2334/IG/747
Updated with Decision(2018)2127 of 04/04/2018
06/04/2018 Centralised - Yearly update (2018)2127 of 04/04/2018