Pantoloc Control

RSS
Withdrawn

This medicine's authorisation has been withdrawn

pantoprazole
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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The marketing authorisation for PANTOLOC Control has been withdrawn at the request of the marketing-authorisation holder.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

English (EN) (250.71 KB - PDF)

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български (BG) (340.44 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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español (ES) (252.29 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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čeština (CS) (326.49 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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dansk (DA) (251.47 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Deutsch (DE) (254.12 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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eesti keel (ET) (250.74 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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ελληνικά (EL) (341.93 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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français (FR) (254.06 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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italiano (IT) (274.87 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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latviešu valoda (LV) (301.98 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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lietuvių kalba (LT) (299.44 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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magyar (HU) (297.85 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Malti (MT) (304.54 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Nederlands (NL) (252.26 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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polski (PL) (324.73 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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português (PT) (252.86 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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română (RO) (300.23 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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slovenčina (SK) (324.89 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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slovenščina (SL) (314.03 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Suomi (FI) (251.1 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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svenska (SV) (274.56 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Product information

Pantoloc Control : EPAR - Product Information

English (EN) (600.2 KB - PDF)

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български (BG) (1.07 MB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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español (ES) (583.66 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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čeština (CS) (875.66 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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dansk (DA) (613.28 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Deutsch (DE) (652.38 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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eesti keel (ET) (617.31 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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ελληνικά (EL) (1.02 MB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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français (FR) (612.45 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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hrvatski (HR) (630.71 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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íslenska (IS) (544.96 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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italiano (IT) (633.07 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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latviešu valoda (LV) (888.24 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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lietuvių kalba (LT) (652.93 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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magyar (HU) (880.31 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Malti (MT) (920.18 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Nederlands (NL) (656.74 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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norsk (NO) (570.97 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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polski (PL) (903.95 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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português (PT) (545.3 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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română (RO) (622.05 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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slovenčina (SK) (893.89 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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slovenščina (SL) (862.7 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Suomi (FI) (544.55 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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svenska (SV) (604.01 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Latest procedure affecting product information: WS/1891/G
14/01/2021
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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

English (EN) (172.49 KB - PDF)

First published: Last updated:
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български (BG) (253.21 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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español (ES) (173.2 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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čeština (CS) (208.38 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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dansk (DA) (173.02 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Deutsch (DE) (172.99 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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eesti keel (ET) (173.36 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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ελληνικά (EL) (250.46 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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français (FR) (173.04 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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hrvatski (HR) (198.63 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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íslenska (IS) (181.13 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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italiano (IT) (172.91 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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latviešu valoda (LV) (247.6 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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lietuvių kalba (LT) (242.14 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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magyar (HU) (247.53 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Malti (MT) (245.34 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Nederlands (NL) (172.36 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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norsk (NO) (181.03 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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polski (PL) (246.38 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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português (PT) (173.72 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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română (RO) (236.59 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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slovenčina (SK) (209.5 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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slovenščina (SL) (179.91 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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Suomi (FI) (172.58 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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svenska (SV) (173.01 KB - PDF)

First published: 22/06/2009Last updated: 18/01/2022
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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

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

English (EN) (473.19 KB - PDF)

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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

English (EN) (274.61 KB - PDF)

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Pantoloc Control : EPAR - Public assessment report

English (EN) (632.57 KB - PDF)

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CHMP summary of positive opinion for Pantoloc Control

Reference Number: EMEA/CHMP/108579/2009

English (EN) (196.9 KB - PDF)

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Public statement on PANTOLOC Control : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/10922/2022

English (EN) (291.48 KB - PDF)

First published:
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