Somac Control
pantoprazole
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Somac Control. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Somac Control.
Authorisation details
Product details | |
---|---|
Name |
Somac Control
|
Agency product number |
EMEA/H/C/001098
|
Active substance |
pantoprazole
|
International non-proprietary name (INN) or common name |
pantoprazole
|
Therapeutic area (MeSH) |
Gastroesophageal Reflux
|
Anatomical therapeutic chemical (ATC) code |
A02BC02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Takeda GmbH
|
Revision |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
12/06/2009
|
Contact address |
Byk-Gulden-Strasse 2
D-78467 Konstanz Germany |
Product information
26/04/2023 Somac Control - EMEA/H/C/001098 - WS2321
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic indication
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.