Vyxeos liposomal (previously known as Vyxeos)

RSS

daunorubicin / cytarabine

Authorised
This medicine is authorised for use in the European Union.

Overview

Vyxeos is a cancer medicine used to treat adults with newly diagnosed acute myeloid leukaemia, a cancer of white blood cells. Vyxeos 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 are daunorubicin and cytarabine.

This EPAR was last updated on 18/11/2019

Authorisation details

Product details
Name
Vyxeos liposomal (previously known as Vyxeos)
Agency product number
EMEA/H/C/004282
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
L01XY01
OrphanOrphan

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
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
23/08/2018
Contact address

Fifth Floor Waterloo Exchange
Waterloo Road
D04 E5W7
Dublin 4
Ireland

Product information

25/10/2019 Vyxeos liposomal (previously known as Vyxeos) - EMEA/H/C/004282 - IAIN/0004

Contents

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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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