On 17 January 2018, orphan designation (EU/3/17/1961) was granted by the European Commission to Astellas Pharma Europe B.V., the Netherlands, for gilteritinib (also known as ASP2215) for the treatment of acute myeloid leukaemia.
Xospata for treatment of acute myeloid leukaemia has been authorised in the EU as Xospata since 2019.
Treatment of acute myeloid leukaemia
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Review of designation
Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: