🇪🇺 Gilteritinib Exposure in European Union

EMA authorised Gilteritinib Exposure on 24 October 2019

Marketing authorisation

EMA — authorised 24 October 2019

  • Application: EMEA/H/C/004752
  • Marketing authorisation holder: Astellas Pharma Europe B.V.
  • Local brand name: Xospata
  • Indication: Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
  • Pathway: orphan
  • Status: approved

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Gilteritinib Exposure in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Gilteritinib Exposure approved in European Union?

Yes. EMA authorised it on 24 October 2019.

Who is the marketing authorisation holder for Gilteritinib Exposure in European Union?

Astellas Pharma Europe B.V. holds the EU marketing authorisation.