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Community register of veterinary medicinal products


Product information

Invented name: Poulvac E. coli   
Auth. number : EU/2/12/140
Active substance : 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,future layer/breeders and turkeys in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with Escherichia coli serotype O78.

Onset of immunity:
Chickens: 2 weeks after vaccination for the reduction of lesions. The onset of immunity has not been established for the mortality claim.
Turkeys: 3 weeks after second vaccination for the reduction of lesions and mortality.
Duration of immunity:
Chickens: 8 weeks for the reduction of lesions and 12 weeks for the reduction of mortality (spray). 12 weeks for the reduction of lesions and mortality (drinking water).
Turkeys: duration of immunity has not been established.

A cross protection study showed reduction of incidence and severity of airsacculitis caused by E. coli serotypes O1, O2 and O18 for spray application for chickens. 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
Updated with Decision(2014)5497 of 28/07/2014
05/09/2013 Centralised - Variation EMEA/V/C/2007/IA/3/G
Updated with Decision(2014)5497 of 28/07/2014
29/07/2014 Centralised - Yearly update (2014)5497 of 28/07/2014
24/04/2015 Centralised - Variation EMEA/V/C/2007/IG/544
Updated with Decision(2015)5454 of 28/07/2015
26/06/2015 Centralised - Variation EMEA/V/C/2007/IG/543/G
Updated with Decision(2016)2231 of 12/04/2016
30/07/2015 Centralised - 2-Monthly update EMEA/V/C/2007/II/6 (2015)5454 of 28/07/2015
14/04/2016 Centralised - Variation EMEA/V/C/2007/X/8 (2016)2231 of 12/04/2016
17/05/2017 Centralised - Renewal EMEA/V/C/2007/R/12 (2017)3407 of 15/05/2017
10/10/2017 Corrigendum (2017)3407 of 15/05/2017