Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1778373
Name of medicinal product: VYXEOS
Active substances:
Cytarabine+Daunorubicin
Estonian, English, Latin
ATC code: L01XY01
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mg+44mg
Amount in package: 2TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Jazz Pharmaceuticals Ireland Limited 
Marketing authorization number: EU/1/18/1308 
Marketing authorization issued on: August 27, 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: August 22, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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