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.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
L01XX23
ATC Item
mitotane
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Lysodren
Medicine Name
Lysodren
Aliases
N/ANo risk management plan link.
