Vyxeos liposomal (previously known as Vyxeos)


daunorubicin / cytarabine

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 10/11/2022

Authorisation details

Product details
Vyxeos liposomal (previously known as Vyxeos)
Agency product number
Active substance
  • daunorubicin hydrochloride
  • cytarabine
International non-proprietary name (INN) or common name
  • daunorubicin
  • cytarabine
Therapeutic area (MeSH)
Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Jazz Pharmaceuticals Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Fifth Floor Waterloo Exchange
Waterloo Road
D04 E5W7
Dublin 4

Product information

10/11/2022 Vyxeos liposomal (previously known as Vyxeos) - EMEA/H/C/004282 - IB/0036/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

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).

Assessment history

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