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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Optimark has been withdrawn at the request of the marketing authorisation holder.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
23/07/2007
Contact address
Guerbet
15, rue des Vanesses
93420 Villepinte
France

Product information

11/04/2017 Optimark - EMEA/H/C/000745 - T/0037

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

Related content

How useful was this page?

Add your rating