The marketing authorisation for Optimark has been withdrawn at the request of the marketing authorisation holder.
Optimark : EPAR - Summary for the public (PDF/555.62 KB)
First published: 02/08/2007
Last updated: 16/06/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Magnetic Resonance Imaging
|Anatomical therapeutic chemical (ATC) code||
Mallinckrodt Deutschland GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
15, rue des Vanesses
11/04/2017 Optimark - EMEA/H/C/000745 - T/0037
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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).
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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.