Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Poulvac E. coli   
Auth. number : EU/2/12/140
INN : Live aroA gene deleted Escherichia coli, type O78, strain EC34195
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI01 - Immunologicals for aves
Pharmacological subgroup: QI01A - Domestic fowl
Chemical subgroup: QI01AE - Live bacterial vaccines
Chemical substance: QI01AE04 - Escherichia
(See WHO ATCvet Index)
Indication: For active immunisation of broiler chickens and future layer/breeders in order to reduce mortality and
lesions (pericarditis, perihepatitis, airsacculitis) associated with Escherichia coli serotype O78.
Onset of immunity: 2 weeks after vaccination for the reduction of lesions. The onset of immunity has
not been established for the mortality claim. Duration of immunity: 8 weeks after vaccination has been demonstrated for the reduction of lesions
and 12 weeks after vaccination for the reduction of mortality.
A cross protection study showed reduction of incidence and severity of airsacculitis caused by E. coli
serotypes O1, O2 and O18. For these serotypes no onset of immunity or duration of immunity was
established.
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
20/06/2012 Centralised - Authorisation EMEA/V/C/2007 (2012)4207 of 15/06/2012
24/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/2007/T/1 (2013)3099 of 22/05/2013
12/07/2013 Centralised - Variation EMEA/V/C/2007/IB/2/G
05/09/2013 Centralised - Variation EMEA/V/C/2007/IA/3/G