Optimark

RSS

gadoversetamide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Optimark has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 11/12/2017

Authorisation details

Product details
Name
Optimark
Agency product number
EMEA/H/C/000745
Active substance
gadoversetamide
International non-proprietary name (INN) or common name
gadoversetamide
Therapeutic area (MeSH)
Magnetic Resonance Imaging
Anatomical therapeutic chemical (ATC) code
V08CA06
Publication details
Marketing-authorisation holder
Mallinckrodt Deutschland GmbH
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
22/07/2007
Contact address
Guerbet
15, rue des Vanesses
93420 Villepinte
France

Product information

10/04/2017 Optimark - EMEA/H/C/000745 - T/0037

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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