Pantecta Control
Withdrawn
This medicine's authorisation has been withdrawn
pantoprazole
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 19 September 2016, the European Commission withdrew the marketing authorisation for Pantecta 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.
Pantecta Control was granted marketing authorisation in the EU as an over-the-counter product on 12 June 2009 for the 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.
Pantecta Control was a duplicate application to Pantozol Control 20 mg gastro-resistant tablets, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Pantozol Control 20 mg gastro-resistant tablets and the remaining duplicates Controloc Control 20 mg gastro-resistant tablets, Somac Control 20 mg gastro-resistant tablets and Pantoloc Control 20 mg gastro-resistant tablets.
The European Public Assessment Report (EPAR) for Pantecta Control is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IG/0634
19/09/2016
This medicine’s product information is available in all official EU languages.
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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).
Product details
- Name of medicine
- Pantecta 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 inhibitorsTherapeutic indication
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
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