Controloc Control

RSS

pantoprazole

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Controloc 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 Controloc Control.

This EPAR was last updated on 02/08/2019

Authorisation details

Product details
Name
Controloc Control
Agency product number
EMEA/H/C/001097
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
11
Date of issue of marketing authorisation valid throughout the European Union
11/06/2009
Contact address
Byk-Gulden-Strasse 2
D-78467 Konstanz
Germany

Product information

17/01/2019 Controloc Control - EMEA/H/C/001097 - WS/1422

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Proton pump inhibitors

Therapeutic indication

Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

Assessment history

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

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