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Community register of veterinary medicinal products


Product information

Invented name: Zulvac 1 Ovis   
Auth. number : EU/2/11/131
Active substance : 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: For active immunisation of sheep from 1 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotype 1.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Onset of immunity: 21 days after completion of the primary vaccination scheme
Duration of immunity: 12 months after completion of the primary vaccination scheme
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
11/09/2014 Centralised - Yearly update (2014)6469 of 09/09/2014
20/04/2016 Centralised - Renewal EMEA/V/C/2335/R/11 (2016)2432 of 18/04/2016
23/03/2017 Centralised - Variation EMEA/V/C/2335/IG/747
Updated with Decision(2018)2128 of 04/04/2018
06/04/2018 Centralised - Yearly update (2018)2128 of 04/04/2018