On 12 June 2002, orphan designation (EU/3/02/102) was granted by the European Commission to Laboratoire HRA Pharma, France, for mitotane for the treatment of adrenal cortical carcinoma.
Mitotane has been authorised in the EU as Lysodren since 28 April 2004.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
|Disease / condition||
Treatment of adrenal cortical carcinoma
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.