Optimark

Withdrawn

This medicine's authorisation has been withdrawn

gadoversetamide

Overview

The marketing authorisation for Optimark (gadoversetamide) expired on 25 July 2017 following the decision of the marketing authorisation holder, Guerbet, not to apply for a renewal of the marketing authorisation. 

Optimark was granted marketing authorisation in the European Union (EU) on 23 July 2007 for use with magnetic resonance imaging (MRI) of the central nervous system and the liver. The marketing authorisation was valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2012. 

The European Public Assessment Report (EPAR) for Optimark is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Optimark : EPAR - Summary for the public

Product information

Optimark : EPAR - Product Information

Optimark : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Optimark
• Active substance:
  gadoversetamide
• International non-proprietary name (INN) or common name:
  gadoversetamide
• Therapeutic area (MeSH):
  Magnetic Resonance Imaging
• Anatomical therapeutic chemical (ATC) code:
  V08CA06

Pharmacotherapeutic group

Contrast media

Therapeutic indication

This medicinal product is for diagnostic use only.

Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.

Authorisation details

• EMA product number:
  EMEA/H/C/000745
• Marketing authorisation holder:
  Mallinckrodt Deutschland GmbH

  Guerbet; 15, rue des Vanesses; 93420 Villepinte; France

• Marketing authorisation issued:
  23/07/2007
• Withdrawal of marketing authorisation:
  25/07/2017
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

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

Optimark-H-C-PSUSA-00001508/201501 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/696878/2015

Optimark-H-C-745-A20-0004 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/452192/2010

Initial marketing authorisation documents

Optimark : EPAR - Scientific Discussion

Optimark : EPAR - Procedural steps taken before authorisation