Pantoloc Control

Withdrawn

This medicine's authorisation has been withdrawn

pantoprazole

Overview

The marketing authorisation for PANTOLOC Control has been withdrawn at the request of the marketing-authorisation holder.

Pantoloc Control : EPAR - Summary for the public

Product information

Pantoloc Control : EPAR - Product Information

Latest procedure affecting product information: WS/1891/G

14/01/2021

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).

Pantoloc Control : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pantoloc Control
• Active substance:
  pantoprazole
• International non-proprietary name (INN) or common name:
  pantoprazole
• Therapeutic area (MeSH):
  Gastroesophageal Reflux
• Anatomical therapeutic chemical (ATC) code:
  A02BC02

Pharmacotherapeutic group

Proton pump inhibitors

Therapeutic indication

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

Authorisation details

• EMA product number:
  EMEA/H/C/001100
• Marketing authorisation holder:
  Takeda GmbH

  Byk-Gulden-Strasse 2; D-78467 Konstanz; Germany

• Opinion adopted:
  19/02/2009
• Marketing authorisation issued:
  11/06/2009
• Revision:
  18

Assessment history

Changes since initial authorisation of medicine

Pantoloc Control : EPAR - Procedural steps taken and scientific information after authorisation

Pantoloc Control-H-C-PSUSA-00002285-201708 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/446391/2018

Initial marketing authorisation documents

Pantoloc Control : EPAR - Public assessment report

CHMP summary of positive opinion for Pantoloc Control

Reference Number: EMEA/CHMP/108579/2009