Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Porcilis Porcoli   
Auth. number : EU/2/96/001
Active substance : Not available
ATC: Anatomical main group: QI - Immunologicals
Therapeutic subgroup: QI09 - Immunologicals for suidae
Pharmacological subgroup: QI09A - Pig
Chemical subgroup: QI09AB - Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Chemical substance: QI09AB02 - Escherichia
(See WHO ATCvet Index)
Indication: For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains, which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
Marketing Authorisation Holder: Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland
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
01/03/1996 Other procedure - Archives (96)550 of 29/02/1996
01/03/1996 Centralised - Authorisation EMEA/V/C/24 (96)550 of 29/02/1996
11/12/2000 Centralised - Variation EMEA/V/C/24/I/2 (2000)3479 of 07/12/2000
18/04/2001 Centralised - Renewal EMEA/V/C/24/R/3 (2001)833 of 10/04/2001
01/06/2001 Centralised - Variation (no change in Commission Decision) EMEA/V/C/24/II/5
15/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/V/C/24/II/6
24/05/2002 Centralised - Variation EMEA/V/C/24/X/4 (2002)1981 of 22/05/2002
27/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/V/C/24/I/7
12/08/2004 Centralised - Variation EMEA/V/C/24/II/8 (2004)3163 of 11/08/2004
13/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/V/C/24/II/10
13/04/2006 Centralised - Renewal EMEA/V/C/24/R/11 (2006)1610 of 10/04/2006
03/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/V/C/24/II/13
26/07/2006 Centralised - Variation EMEA/V/C/24/II/12 (2006)3386 of 20/07/2006
11/05/2009 Centralised - Variation (rejected) EMEA/V/C/24/II/14 (2009)3814 of 07/05/2009
18/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/24/IB/15
10/05/2011 Centralised - Variation EMEA/V/C/24/IB/16
Updated with Decision(2011)9182 of 05/12/2011
07/12/2011 Centralised - Variation (2011)9182 of 05/12/2011
04/04/2014 Centralised - Variation EMEA/V/C/24/IB/420/G
Updated with Decision(2015)2534 of 13/04/2015
15/04/2015 Centralised - Yearly update (2015)2534 of 13/04/2015