Optimark

Withdrawn

This medicine's authorisation has been withdrawn

gadoversetamide

Overview

The marketing authorisation for Optimark has been withdrawn at the request of the marketing authorisation holder.

Optimark : EPAR - Summary for the public

Product information

Optimark : EPAR - Product Information

Latest procedure affecting product information: T/0037

11/04/2017

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).

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
• 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