Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: PANTECTA Control
Auth. number : EU/1/09/518
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/1099 (2009)4675 of 12/06/2009
08/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1099/IG/6
13/07/2010 Centralised - Variation (refusal) EMEA/H/C/1099/IG/5
20/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1099/WS/IB/49
02/02/2011 Centralised - Variation (refusal) EMEA/H/C/1099/IG/43/G
27/05/2011 Centralised - Variation EMEA/H/C/1099/IG/70
Updated with Decision(2011)9283 of 07/12/2011
09/12/2011 Centralised - Variation EMEA/H/C/1099/WS/122 (2011)9283 of 07/12/2011
08/02/2013 Centralised - Variation EMEA/H/C/1099/IG/268/G
Updated with Decision(2013)3221 of 27/05/2013
29/05/2013 Centralised - 2-Monthly update EMEA/H/C/1099/WS/341 (2013)3221 of 27/05/2013
25/02/2014 Centralised - Renewal EMEA/H/C/1099/R/16 (2014)1306 of 21/02/2014
16/02/2015 Centralised - Notification EMEA/H/C/1099/N/19
Updated with Decision(2015)4856 of 08/07/2015
10/07/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1099/T/20 (2015)4856 of 08/07/2015
25/11/2015 Centralised - Variation EMEA/H/C/1099/IG/634
Updated with Decision(2016) 5970 of 15/09/2016
19/09/2016 Centralised - Yearly update (2016) 5970 of 15/09/2016
21/09/2016 Centralised - Withdrawal (2016) 6084 of 19/09/2016