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Community Register of medicinal products

Community register of veterinary medicinal products
AUTHORISED  

Product information
Invented name: Zulvac 8 Bovis   
Auth. number : EU/2/09/105
INN : Inactivated bluetongue virus, serotype 8
ATC: QI - Immunologicals
QI02 - Immunologicals for bovidae
QI02A - Cattle
QI02AA - Inactivated viral vaccines
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, serotype 8.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  EPAR and active package presentations

Package presentations

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.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/01/2010 Centralised - Authorisation EMEA/V/C/145 (2010)186 of 15/01/2010
20/08/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/145/T/1 (2010)5850 of 18/08/2010
14/10/2010 Centralised - Variation EMEA/V/C/145/WS/1
17/03/2011 Centralised - Variation EMEA/V/C/145/II/2 (2011)1791 of 14/03/2011
25/05/2011 Centralised - Annual reassessment EMEA/V/C/145/S/3
15/11/2011 Centralised - Variation EMEA/V/C/145/IA/6/G
Updated with Decision(2011)8257 of 10/11/2011
15/11/2011 Centralised - Variation - (2011)8257 of 10/11/2011
11/08/2012 Centralised - Annual reassessment EMEA/V/C/145/S/8