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Vyxeos



Jazz Pharmaceuticals Ireland LimitedEU/1/18/1308/001-003

Main Information

Trade NameVyxeos
Active SubstancesCytarabine
DAUNOMYCIN HYDROCHLORIDE
Dosage FormPowder for concentrate for solution for infusion
Licence HolderJazz Pharmaceuticals Ireland Limited
Licence NumberEU/1/18/1308/001-003

Group Information

ATC CodeL01XY01 daunorubicin hydrochloride and cytarabine

Status

License statusAuthorised
Licence Issued23/08/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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