Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Zulvac 1+8 Bovis   
Auth. number : EU/2/12/139
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: 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 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Onset of immunity: 21 day after administration of the second dose.
The duration of immunity: 12 months.
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 continues to be 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
12/03/2012 Centralised - Authorisation EMEA/V/C/2473 (2012)1630 of 08/03/2012
24/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/2473/T/2 (2013)3104 of 22/05/2013
05/09/2013 Centralised - Variation EMEA/V/C/2473/IG/330/G
Updated with Decision(2013)7812 of 08/11/2013
13/11/2013 Centralised - Variation EMEA/V/C/2473/S/3 (2013)7812 of 08/11/2013