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Pharmaceuticals - Community Register
Community list of not active medicinal products for human use |
NOT RENEWED |
Product information |
Invented name: | Optimark |
Auth. number : | EU/1/07/398 |
Active substance : | Gadoversetamide |
ATC: | Anatomical main group: V - Various Therapeutic subgroup: V08 - Contrast media Pharmacological subgroup: V08C - Magnetic resonance imaging contrast media Chemical subgroup: V08CA - Paramagnetic contrast media Chemical substance: V08CA06 - gadoversetamide (See WHO ATC Index) |
Indication: | 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 adult patients and in children of two years and older with known or highly suspected pathology. |
Marketing Authorisation Holder: | Guerbet
15 rue des Vanesses, 93420, Villepinte, France |
EPAR and active package presentations![]() | |
Package presentations |
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 is 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 (no change in Commission Decision) | 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 (no change in Commission Decision) | EMEA/H/C/745/IA/6 | ||||
11/02/2011 | Centralised - Variation (no change in Commission Decision) | 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 | |||
13/12/2013 | Centralised - Variation | EMEA/H/C/745/IB/19 | ||||
Updated with Decision(2014)9301 of 01/12/2014 | ||||||
13/02/2014 | Centralised - Variation | EMEA/H/C/745/IA/20 | ||||
Updated with Decision(2014)9301 of 01/12/2014 | ||||||
25/09/2014 | Centralised - Variation | EMEA/H/C/745/II/21 | ||||
Updated with Decision(2014)9301 of 01/12/2014 | ||||||
03/12/2014 | Centralised - Yearly update | (2014)9301 of 01/12/2014 | ||||
15/12/2014 | Centralised - Variation | EMEA/H/C/745/IB/25 | ||||
Updated with Decision(2015)3812 of 02/06/2015 | ||||||
05/06/2015 | Centralised - 2-Monthly update | EMEA/H/C/745/IB/27 | (2015)3812 of 02/06/2015 | |||
23/11/2015 | PSUSA - Modification | EMEA/H/C/745/PSUSA/15084/201501 | (2015)8281 of 19/11/2015 | |||
10/03/2016 | Centralised - Variation | EMEA/H/C/745/II/31 | ||||
Updated with Decision(2017)1256 of 16/02/2017 | ||||||
20/07/2016 | Centralised - Variation | EMEA/H/C/745/IB/36 | ||||
Updated with Decision(2017)1256 of 16/02/2017 | ||||||
20/02/2017 | Centralised - Yearly update | (2017)1256 of 16/02/2017 | ||||
13/04/2017 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/745/T/37 | (2017)3627 of 11/04/2017 | |||
25/07/2017 | Centralised - Withdrawal (not renewed) | |||||
27/12/2017 | Referral | EMEA/H/A-31/1437/C/745/34 | (2017)7942 of 23/11/2017 |