Teslascan

Withdrawn

This medicine's authorisation has been withdrawn

mangafodipir

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decision the European Public Assessment Report for Teslascan is updated to reflect that the marketing authorisation is no longer valid.

Teslascan : EPAR - Summary for the public

Product information

Teslascan : EPAR - Product Information

Teslascan : EPAR - All Authorised presentations

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 media

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000137
• Marketing authorisation holder:
  GE Healthcare AS

  Nycoveien 1; NO-0401 Oslo; Norway

• Marketing authorisation issued:
  22/05/1997
• Withdrawal of marketing authorisation:
  21/06/2012
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Teslascan : EPAR - Procedural steps taken and scientific information after authorisation

Teslascan : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Teslascan : EPAR - Procedural steps taken before authorisation

Teslascan : EPAR - Scientific Discussion