Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: SOMAC Control   
Auth. number : EU/1/09/516
Active substance : pantoprazole
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A02 - Drugs for acid related disorders
Pharmacological subgroup: A02B - Drugs for treatment of peptic ulcer
Chemical subgroup: A02BC - Proton pump inhibitors
Chemical substance: A02BC02 - Pantoprazole
(See WHO ATC Index)
Indication: Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Marketing Authorisation Holder: Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland
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
16/06/2009 Centralised - Authorisation EMEA/H/C/1098 (2009)4679 of 12/06/2009
20/05/2010 Centralised - Notification EMEA/H/C/1098/N/1
Updated with Decision(2011)9177 of 05/12/2011
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1098/IG/6
13/07/2010 Centralised - Variation (refusal) EMEA/H/C/1098/IG/5
20/12/2010 Centralised - Variation EMEA/H/C/1098/WS/49
02/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1098/IG/43/G
27/05/2011 Centralised - Variation EMEA/H/C/1098/IG/70
Updated with Decision(2011)9177 of 05/12/2011
07/12/2011 Centralised - Variation EMEA/H/C/1098/WS/122 (2011)9177 of 05/12/2011
08/02/2013 Centralised - Variation EMEA/H/C/1098/IG/268/G
Updated with Decision(2013)3391 of 30/05/2013
03/06/2013 Centralised - 2-Monthly update EMEA/H/C/1098/WS/341 (2013)3391 of 30/05/2013
25/02/2014 Centralised - Renewal EMEA/H/C/1098/R/17 (2014)1309 of 21/02/2014
16/02/2015 Centralised - Notification EMEA/H/C/1098/N/20
Updated with Decision(2015)4872 of 08/07/2015
10/07/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1098/T/21 (2015)4872 of 08/07/2015
25/11/2015 Centralised - Variation EMEA/H/C/1098/IG/634
Updated with Decision(2016) 8521 of 08/12/2016
23/11/2016 Centralised - Variation EMEA/H/C/1098/IG/742
12/12/2016 Centralised - Yearly update (2016) 8521 of 08/12/2016