This is a summary of the European public assessment report (EPAR) for Lysodren. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lysodren.
Lysodren : EPAR - Summary for the public (PDF/76.28 KB)
First published: 29/04/2009
Last updated: 18/07/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Adrenal Cortex Neoplasms
|Anatomical therapeutic chemical (ATC) code||
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Laboratoire HRA Pharma
|Date of issue of marketing authorisation valid throughout the European Union||
24/04/2016 Lysodren - EMEA/H/C/000521 - IA/0018
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma.
The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.