European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Optimark
|
| Auth. number : | EU/1/07/398 |
| INN : | Gadoversetamide |
| ATC: | V - Various V08 - Contrast media V08C - Magnetic resonance imaging contrast media V08CA - Paramagnetic contrast media V08CA06 - Gadoversetamide (See WHO ATC Index) |
| 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 visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology. |
| Marketing Authorisation Holder: | Mallinckrodt Deutschland GmbH
Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information". Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 25/07/2007 | Centralised - Authorisation | EMEA/H/C/745 | (2007)3627 of 23/07/2007 | |||
| 31/03/2008 | Centralised - Variation | EMEA/H/C/745/II/1 | (2008)1255 of 27/03/2008 | |||
| 30/04/2008 | Centralised - Variation | EMEA/H/C/745/IA/2 | ||||
| Updated with Decision(2008)8253 of 05/12/2008 | ||||||
| 09/12/2008 | Centralised - Variation | - | (2008)8253 of 05/12/2008 | |||
| 08/04/2009 | Centralised - Variation | EMEA/H/C/745/II/3 | (2009)2729 of 03/04/2009 | |||
| 12/11/2009 | Centralised - Variation | EMEA/H/C/745/IA/5 | ||||
| 12/05/2010 | Referral | EMEA/H/C/745/A-20/4 | (2010)3169 of 10/05/2010 | |||
| 12/11/2010 | Centralised - Variation | EMEA/H/C/745/IA/6 | ||||
| 11/02/2011 | Centralised - Variation | EMEA/H/C/745/IB/7/G | ||||
| 07/10/2011 | Centralised - Variation | EMEA/H/C/745/IA/9/G | ||||
| Updated with Decision(2012)759 of 06/02/2012 | ||||||
| 08/02/2012 | Centralised - Variation | - | (2012)759 of 06/02/2012 | |||
| 26/03/2012 | Centralised - Variation | EMEA/H/C/745/II/10 | (2012)2866 of 20/04/2012 | |||
| 19/06/2012 | Centralised - Renewal | EMEA/H/C/745/R/12 | (2012)4204 of 15/06/2012 | |||
| 15/03/2013 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/745/T/15 | (2013)1645 of 13/03/2013 |