Vyxeos liposomal (previously known as Vyxeos)
daunorubicin / cytarabine
Table of contents
Overview
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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Vyxeos liposomal : EPAR - Medicine overview (PDF/118.26 KB)
First published: 26/10/2018
Last updated: 06/03/2020
EMA/631389/2019 -
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Vyxeos : EPAR - Risk-management-plan summary (PDF/76 KB)
First published: 26/10/2018
Authorisation details
Product details | |
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Name |
Vyxeos liposomal (previously known as Vyxeos)
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Agency product number |
EMEA/H/C/004282
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Leukemia, Myeloid, Acute
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Anatomical therapeutic chemical (ATC) code |
L01XY01
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Orphan |
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 | |
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Marketing-authorisation holder |
Jazz Pharmaceuticals Ireland Limited
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
23/08/2018
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Contact address |
Product information
06/01/2021 Vyxeos liposomal (previously known as Vyxeos) - EMEA/H/C/004282 - IB/0015
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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).