Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Dukoral   
Auth. number : EU/1/03/263
INN : Oral cholera vaccine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07A - Bacterial vaccines
Chemical subgroup: J07AE - Cholera vaccines
Chemical substance: J07AE01 - Cholera, inactivated, whole cell
(See WHO ATC Index)
Indication: DUKORAL is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.The use of DUKORAL should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.DUKORAL should not replace standard protective measures. In the event of diarrhoea measures of rehydration should be instituted.
Marketing Authorisation Holder: Crucell Sweden AB
SE-105 21 Stockholm, Sverige

  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
03/05/2004 Centralised - Authorisation EMEA/H/C/476 (2004)1769 of 28/04/2004
04/08/2004 Centralised - Variation EMEA/H/C/476/IB/1
25/10/2004 Centralised - Variation EMEA/H/C/476/II/6
25/10/2004 Centralised - Variation EMEA/H/C/476/II/5
14/01/2005 Centralised - Variation EMEA/H/C/476/IA/9
Updated with Decision(2005)3226 of 16/08/2005
18/08/2005 Centralised - Variation EMEA/H/C/476/II/10 (2005)3226 of 16/08/2005
31/03/2006 Corrigendum (2005)3226 corr of 29/03/2006
24/07/2007 Centralised - Variation EMEA/H/C/476/II/11
23/11/2007 Centralised - Variation EMEA/H/C/476/II/12
28/08/2008 Centralised - Variation EMEA/H/C/476/N/13
Updated with Decision(2009)2289 of 25/03/2009
02/10/2008 Centralised - Variation EMEA/H/C/476/II/14
30/03/2009 Centralised - Renewal EMEA/H/C/476/R/15 (2009)2289 of 25/03/2009
12/05/2009 Centralised - Variation EMEA/H/C/476/II/16
09/11/2009 Centralised - Variation EMEA/H/C/476/IA/20
09/11/2009 Centralised - Variation EMEA/H/C/476/IA/19
09/11/2009 Centralised - Variation EMEA/H/C/476/IB/18
25/03/2010 Centralised - Variation EMEA/H/C/476/II/21
26/04/2010 Centralised - Variation EMEA/H/C/476/IA/24
Updated with Decision(2011)1213 of 21/02/2011
26/04/2010 Centralised - Variation EMEA/H/C/476/IA/22
Updated with Decision(2011)1213 of 21/02/2011
26/04/2010 Centralised - Variation EMEA/H/C/476/IA/23
Updated with Decision(2011)1213 of 21/02/2011
26/05/2010 Centralised - Variation EMEA/H/C/476/IB/26
26/05/2010 Centralised - Variation EMEA/H/C/476/IB/25
06/12/2010 Centralised - Variation EMEA/H/C/476/IA/28/G
25/01/2011 Centralised - Variation EMEA/H/C/476/IB/29/G
Updated with Decision(2011)1213 of 21/02/2011
10/02/2011 Centralised - Variation EMEA/H/C/476/IB/30
01/03/2011 Centralised - Variation EMEA/H/C/476/II/27/G (2011)1213 of 21/02/2011
30/04/2014 Centralised - Variation EMEA/H/C/476/IB/42