Is Cytarabine + Daunorubicin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Cytarabine + Daunorubicin, including Vyxeos (2.2,5 mg/ml,mg/ml, Powder for concentrate for solution for infusion, SAR 23892.40).

Is Cytarabine + Daunorubicin approved by the US FDA?

Drugs@FDA lists 1 application product line for Cytarabine + Daunorubicin, including VYXEOS (Prescription).

Is Cytarabine + Daunorubicin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cytarabine + Daunorubicin: Vyxeos liposomal (previously Vyxeos).

Active substances

Cytarabine + Daunorubicin

SFDA 1
US FDA 1
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Vyxeos	2.2,5 mg/ml,mg/ml	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 23892.40	NCE · Prescription	Jazz Pharmaceutical Ireland Ltd	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VYXEOS	100MG;44MG	powder · intravenous	JAZZ PHARMS THERAP	Prescription	3 Aug 2017

EMA European Union — centrally authorised medicines

Vyxeos liposomal (previously Vyxeos) Jazz Pharmaceuticals Ireland Limited · Authorised · authorised 23 Aug 2018 · ATC L01XY01

Therapeutic indication (EMA)

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).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VYXEOS	02515490	100 MG; 44 MG	POWDER · INTRAVENOUS	JAZZ PHARMACEUTICALS IRELAND LIMITED

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.