Is Cytarabine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Cytarabine, including ALEXAN 1000MG- 20ML VIAL (50 mg/ml, Solution for injection/infusion, SAR 103.70); ALEXAN 2000MG- 40ML VIAL (50 mg/ml, Solution for injection/infusion, SAR 173.15); ALEXAN 20MG-1ML VIAL (20 mg/ml, Solution for injection/infusion, SAR 36.20); ALEXAN 500MG- 10ML (50 mg/ml, Solution for injection/infusion, SAR 51.75); CYTARABINE 100MG-1ML VIAL (100 mg/ml, Solution for injection, SAR 121.40).

Is Cytarabine approved by the US FDA?

Drugs@FDA lists 23 application product lines for Cytarabine, including CYTARABINE (Prescription); CYTARABINE (Prescription); CYTARABINE (Prescription); CYTARABINE (Prescription); CYTARABINE (Prescription).

Is Cytarabine authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Cytarabine.

Is Cytarabine on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Acute myeloid leukaemia with recurrent genetic abnormalities; Burkitt lymphoma including Burkitt leukaemia; Lymphoid leukaemia, not elsewhere classified; Myeloid leukaemia; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Langerhans cell histiocytosis.

Are there safety signals or safety updates for Cytarabine?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-01-27).

Active substance

Cytarabine

SFDA 12
US FDA 23
EMA 1
Health Canada 3
WHO EML 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALEXAN 1000MG- 20ML VIAL	50 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 103.70	Generic · Prescription	EBEWE PHARMA	Valid
ALEXAN 2000MG- 40ML VIAL	50 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 173.15	Generic · Prescription	EBEWE PHARMA	Valid
ALEXAN 20MG-1ML VIAL	20 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 36.20	Generic · Prescription	EBEWE PHARMA	Valid
ALEXAN 500MG- 10ML	50 mg/ml	Solution for injection/infusion · Intravenous use	1 Vial	SAR 51.75	Generic · Prescription	EBEWE PHARMA	Valid
CYTARABINE 100MG-1ML VIAL	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 121.40	Generic · Prescription	HOSPIRA UK LIMITED	Valid
CYTARABINE 100MG-1ML VIAL	100 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 302.85	Generic · Prescription	HOSPIRA UK LIMITED	Valid
CYTARABINE 100MG-1ML VIAL	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 121.40	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed
CYTARABINE 100MG-1ML VIAL	100 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 302.85	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed
CYTOSAR 1GM VIAL I.V	1 g	Solution for injection · Intravenous use	1 Vial	SAR 149.60	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
CYTOSAR VIAL 100 MG	100 mg	Solution for injection · Intravenous use	1 Vial	SAR 21.10	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
CYTOSAR VIAL 500MG	500 mg	Solution for injection · Intravenous use	1 Vial	SAR 82.65	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed
DBL CYTARABINE 100MG-5ML VIAL	20 mg/ml	Injection · Intravenous use	5 Vial	SAR 87.95	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); ADULT ACUTE MYELOID LEUKAEMIA (AML); BURKITT`S LYMPHOMA; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; LYMPHOPLASMACYTIC LYMPHOMA; MANTLE CELL LYMPHOMA; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL); PEDIATRIC B-CELL LYMPHOMA; T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
CYTARABINE	100MG/VIAL	injectable · injection	HIKMA PHARMS	Prescription	2 Aug 1989
CYTARABINE	500MG/VIAL	injectable · injection	HIKMA PHARMS	Prescription	2 Aug 1989
CYTARABINE	20MG/ML	injectable · injection	HOSPIRA	Prescription	4 Jun 1990
CYTARABINE	20MG/ML	injectable · injection	HOSPIRA	Prescription	31 Aug 1990
CYTARABINE	20MG/ML	injectable · injection	HOSPIRA	Prescription	28 Feb 1994
CYTARABINE	1GM/VIAL; 2GM/VIAL	injectable · injection	WEST-WARD PHARMS INT	Prescription	31 Aug 1994
CYTARABINE	100MG/ML	injectable · injection	HOSPIRA	Prescription	22 Nov 1999
CYTARABINE	100MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	15 Jan 2004
CYTARABINE	20MG/ML	injectable · injection	RISING	Prescription	13 Dec 2011
CYTARABINE	100MG/ML	injectable · injection	RISING	Prescription	30 Jan 2012
CYTARABINE	100MG/ML	injectable · injection	MEITHEAL	Prescription	17 Jul 2018
CYTARABINE	100MG/VIAL	injectable · injection	GLAND	Prescription	23 Dec 2019
CYTARABINE	2GM/VIAL	injectable · injection	GLAND	Prescription	23 Dec 2019
CYTARABINE	20MG/ML	injectable · injection	MEITHEAL	Prescription	28 Feb 2022
CYTARABINE	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	TEVA PARENTERAL	Discontinued	17 Jun 1969
CYTOSAR-U	100MG/VIAL; 500MG/VIAL; 2GM/VIAL; 1GM/VIAL	injectable · injection	TEVA PHARMS USA	Discontinued	30 Dec 1998
DEPOCYT	10MG/ML	injectable, liposomal · injection	PACIRA PHARMS INC	Discontinued	1 Apr 1999
CYTARABINE	20MG/ML	injectable · injection	RISING	Discontinued	13 Dec 2011
CYTARABINE	20MG/ML	injectable · injection	PHARMOBEDIENT	Discontinued	13 Dec 2011
CYTARABINE	20MG/ML	injectable · injection	MEITHEAL	Discontinued	9 Nov 2017
CYTARABINE	20MG/ML	injectable · injection	MEITHEAL	Discontinued	26 Jun 2020
CYTARABINE	100MG/VIAL	injectable · injection	QUAD PHARMS	Discontinued
CYTARABINE	500MG/VIAL	injectable · injection	QUAD PHARMS	Discontinued

EMA European Union — centrally authorised medicines

DepoCyte Pacira Limited · Withdrawn · authorised 11 Jul 2001 · ATC L01BC01

Therapeutic indication (EMA)

Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CYTARABINE INJECTION	02126656	100 MG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRATHECAL	PFIZER CANADA ULC
CYTARABINE INJECTION	02515296	100 MG / ML	SOLUTION · INTRAVENOUS; INTRATHECAL; SUBCUTANEOUS	STERIMAX INC
PMS-CYTARABINE	02406772	100 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRATHECAL	PHARMASCIENCE INC

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Acute myeloid leukaemia with recurrent genetic abnormalities; Burkitt lymphoma including Burkitt leukaemia; Lymphoid leukaemia, not elsewhere classified; Myeloid leukaemia; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Langerhans cell histiocytosis
Parenteral > General injections > unspecified: 100 mg in vial powder for injection; 100 mg per mL in vial

Safety signals and safety-related labeling changes

US FDA 27 Jan 2026 VYXEOS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
EMA PRAC 13 May 2016 PRAC signal: Benign intracranial hypertension
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2016 PRAC signal: Benign intracranial hypertension
Action for MAH: update of the product information: No

All safety entries for cytarabine →

Combinations containing Cytarabine

Cytarabine + daunorubicin

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.