Optimark
gadoversetamide
Table of contents
Overview
The marketing authorisation for Optimark has been withdrawn at the request of the marketing authorisation holder.
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
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.