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EMA Product

Vyxeos liposomal (previously Vyxeos)

Product approved by European Medicines Agency (EU)

Basic Information

Vyxeos liposomal (previously Vyxeos)

Regulatory Information

EMEA/H/C/004282

Authorised

August 23, 2018

April 26, 2018

10

May 24, 2024

Company Information

Ireland

Fifth Floor Waterloo Exchange Waterloo Road D04 E5W7 Dublin 4

JAZZ PHARMACEUTICALS IRELAND LIMITED

Drug Classification

Orphan Medicine

Active Substances Detail

daunorubicin hydrochloridecytarabine

Detailed Information

Therapeutic Indication

### Therapeutic indication Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Overview Summary

Vyxeos liposomal is a cancer medicine used to treat adults with newly diagnosed acute myeloid leukaemia, a cancer of white blood cells. It is used when the leukaemia was caused by previous treatments (e.g. for other cancers) or is associated with certain changes in the bone marrow known as myelodysplasia. The active substances in Vyxeos liposomal are daunorubicin and cytarabine.

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