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Pharmaceuticals - Community Register
Community register of veterinary medicinal products
|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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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.
|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|