Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lysodren   
Auth. number : EU/1/04/273
Active substance : Mitotane
Orphan market exclusivity for "Treatment of adrenal cortical carcinoma" (based on designation EU/3/02/102) started on 30/04/2004
   10 years of market exclusivity
   This orphan market exclusivity has ended on 30/04/2014
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX23 - Mitotane
(See WHO ATC Index)
Indication: Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma.
The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.
Marketing Authorisation Holder: Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, 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 proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/04/2004 Centralised - Authorisation EMEA/H/C/521 (2004)1765 of 28/04/2004
04/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/521/IA/1
17/08/2005 Centralised - Variation EMEA/H/C/521/IA/2
Updated with Decision(2006)693 of 28/02/2006
17/08/2005 Centralised - Variation EMEA/H/C/521/IA/3
Updated with Decision(2006)693 of 28/02/2006
06/03/2006 Centralised - Variation (2006)693 of 28/02/2006
30/04/2007 Centralised - Variation EMEA/H/C/521/II/4 (2007)1936 of 26/04/2007
27/03/2009 Centralised - Renewal EMEA/H/C/521/R/5 (2009)2293 of 25/03/2009
06/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/521/IA/7
27/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/521/IB/6
06/01/2010 Centralised - Notification EMEA/H/C/521/N/8
Updated with Decision(2011)7176 of 03/10/2011
20/03/2011 Centralised - Variation EMEA/H/C/521/IA/9/G
Updated with Decision(2011)7176 of 03/10/2011
20/04/2011 Centralised - Notification EMEA/H/C/521/N/10
Updated with Decision(2011)7176 of 03/10/2011
05/10/2011 Centralised - Variation (2011)7176 of 03/10/2011
23/01/2012 Centralised - Variation EMEA/H/C/521/IB/12
Updated with Decision(2012)6013 of 23/08/2012
19/03/2012 Centralised - Notification EMEA/H/C/521/N/13
Updated with Decision(2012)6013 of 23/08/2012
27/08/2012 Centralised - Variation (2012)6013 of 23/08/2012
30/05/2013 Centralised - Variation EMEA/H/C/521/II/14
Updated with Decision(2014)3820 of 03/06/2014
06/12/2013 Centralised - Notification EMEA/H/C/521/N/15
Updated with Decision(2014)3820 of 03/06/2014
30/04/2014 Centralised - (orphan status)
05/06/2014 Centralised - Yearly update (2014)3820 of 03/06/2014
02/03/2015 PSUSA - Modification EMEA/H/C/521/PSUV/16 (2015)1427 of 26/02/2015
25/04/2016 Centralised - Variation EMEA/H/C/521/IAin/18