EMA — authorised 28 April 2004
- Marketing authorisation holder: HRA Pharma Rare Diseases
- Status: approved
🇪🇺 Lysodren in European Union
EMA authorised Lysodren on 28 April 2004
Marketing authorisations
EMA — authorised 28 April 2004
- Application: EMEA/H/C/000521
- Marketing authorisation holder: Esteve Pharmaceuticals, S.A.
- Local brand name: Lysodren
- 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.
- Status: approved
Lysodren in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Lysodren approved in European Union?
Yes. EMA authorised it on 28 April 2004; EMA authorised it on 28 April 2004.
Who is the marketing authorisation holder for Lysodren in European Union?
HRA Pharma Rare Diseases holds the EU marketing authorisation.