Pantoloc Control

Withdrawn

This medicine's authorisation has been withdrawn

pantoprazole

Overview

On 20 December 2021, the European Commission withdrew the marketing authorisation for Pantoloc Control (pantoprazole) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pantoloc Control was granted marketing authorisation in the EU on 12 June 2009 for treatment of reflux symptoms (e.g., heartburn, acid regurgitation). The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. The product had not been marketed in the EU since 2019. 

Pantoloc Control was a duplicate application to Somac Control, Controloc Control, Pantecta Control and Pantozol Control, which are marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Somac Control, Controloc Control, Pantecta Control and Pantozol Control. 

The European Public Assessment Report (EPAR) for Pantoloc Control is updated to indicate that the marketing authorisation is no longer valid.

Pantoloc Control : EPAR - Summary for the public

Product information

Pantoloc Control : EPAR - Product Information

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