Lysodren (mitotane)
- Region
- 🇪🇺 EU
- Active substance
- mitotane
- Company
- Esteve Pharmaceuticals, S.A.
- Status
- Authorised
- Therapeutic area
- Adrenal Cortex Neoplasms
- EU approval
- Wed 28 Apr 2004
- Application
- EMEA/H/C/000521
- ATC
- L01XX23
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.