Optimark

gadoversetamide

  • Email
  • Help

About

The marketing authorisation for Optimark has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Optimark : EPAR - Summary for the public BG = bălgarski 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public ES = español 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public CS = čeština 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public DA = dansk 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public DE = Deutsch 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public ET = eesti keel 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public EL = elliniká 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public EN = English 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public FR = français 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public IT = italiano 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public LV = latviešu valoda 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public LT = lietuvių kalba 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public HU = magyar 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public MT = Malti 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public NL = Nederlands 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public PL = polski 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public PT = português 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public RO = română 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public SK = slovenčina 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public SL = slovenščina 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public FI = suomi 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public SV = svenska 2007-08-02 2016-06-16
Optimark : EPAR - Summary for the public HR = Hrvatski 2007-08-02 2016-06-16

This EPAR was last updated on 11/12/2017 .

Authorisation details

Product details

Product details for Optimark
NameOptimark
Agency product numberEMEA/H/C/000745
Active substance

gadoversetamide

International non-proprietary name (INN) or common name

gadoversetamide

Therapeutic area Magnetic Resonance Imaging
Anatomical therapeutic chemical (ATC) code V08CA06
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Optimark
Marketing-authorisation holder

Mallinckrodt Deutschland GmbH

Revision14
Date of issue of marketing authorisation valid throughout the European Union23/07/2007

Contact address:

Guerbet
15, rue des Vanesses
93420 Villepinte
France

Product information

Product information

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

Name Language First published Last updated
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08
Optimark : EPAR - Product Information HR = Hrvatski 2009-04-23 2017-05-08

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.


Name Language First published Last updated
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  
Optimark : EPAR - All Authorised presentations HR = Hrvatski 2007-08-02  

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Optimark : EPAR - Scientific Discussion HR = Hrvatski 2008-05-30  
Optimark : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2007-08-02  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Optimark