Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Zulvac 1+8 Ovis   
Auth. number : EU/2/11/120
INN : Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 / Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02
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, serotypes 1 and 8.
Onset of immunity: 21 days after completion of the primary vaccination scheme.
Duration of immunity: 12 months.
*(Cycling value (Ct) >= 36 by a validated RT-PCR method, indicating no presence of viral genome)
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
17/03/2011 Centralised - Authorisation EMEA/V/C/2251 (2011)1788 of 14/03/2011
25/05/2011 Centralised - Variation EMEA/V/C/2251/IB/1
Updated with Decision(2011)6642 of 19/09/2011
30/06/2011 Centralised - Variation EMEA/V/C/2251/IG/6/G
Updated with Decision(2011)6642 of 19/09/2011
22/09/2011 Centralised - Variation (2011)6642 of 19/09/2011
12/07/2012 Centralised - Annual reassessment EMEA/V/C/2251/S/5
29/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/2251/T/8 (2013)3224 of 27/05/2013
30/07/2013 Centralised - Annual reassessment EMEA/V/C/2251/S/6 (2013)5007 of 26/07/2013
05/09/2013 Centralised - Variation EMEA/V/C/2251/IG-330/9/G
Updated with Decision(2014)6739 of 16/09/2014
18/09/2014 Centralised - Yearly update (2014)6739 of 16/09/2014