Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

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: Mallinckrodt Deutschland GmbH
Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland
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 proceduresGoto top of the page
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
20/07/2016 Centralised - Variation EMEA/H/C/745/IB/36