Teslascan
Withdrawn
This medicine's authorisation has been withdrawn
mangafodipir
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 22 May 1997 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Teslascan (mangafodipir) for diagnostic use only. Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions. The marketing authorisation holder (MAH) responsible for Teslascan was GE Healthcare AS.
The European Commission was notified by a letter dated 4 May 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Teslascan for commercial reasons. On 21 June 2012 the European Commission issued a decision to withdraw the marketing authorisation for Teslascan.
Pursuant to this decision the European Public Assessment Report for Teslascan is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0016
23/10/2009
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).
Product details
- Name of medicine
- Teslascan
- Active substance
- mangafodipir trisodium
- International non-proprietary name (INN) or common name
- mangafodipir
- Therapeutic area (MeSH)
- Magnetic Resonance Imaging
- Anatomical therapeutic chemical (ATC) code
- V08CA05
Pharmacotherapeutic group
Contrast mediaTherapeutic indication
This medicinal product is for diagnostic use only.
Contrast medium for diagnostic magnetic resonance imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.
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