Is Decitabine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Decitabine, including Decanta (50 mg, Powder for solution for infusion, SAR 3919.70); Decitabine SPC 50mg for Injection (50 mg, Powder for solution for infusion, SAR 2888.20).

Is Decitabine approved by the US FDA?

Drugs@FDA lists 22 application product lines for Decitabine, including DECITABINE (Prescription); DECITABINE (Prescription); DECITABINE (Prescription); DECITABINE (Prescription); DECITABINE (Prescription).

Is Decitabine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Decitabine: Dacogen.

Are there safety signals or safety updates for Decitabine?

EMA PRAC: 1 entry; US FDA: 3 entries (latest 2026-05-13).

Active substance

Decitabine

SFDA 2
US FDA 22
EMA 1
Health Canada 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Decanta	50 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 3919.70	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Decitabine SPC 50mg for Injection	50 mg	Powder for solution for infusion · Intravitreal use	1 Vial	SAR 2888.20	NCE · Prescription	SUDAIR PHARMA COMPANY	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML); MYELODYSPLASTIC SYNDROMES

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

Product	Strength	Form · route	Applicant	Status	First approved
DECITABINE	50MG/VIAL	injectable · intravenous	DR REDDYS	Prescription	11 Jul 2013
DECITABINE	50MG/VIAL	injectable · intravenous	SANDOZ	Prescription	28 Aug 2014
DECITABINE	50MG/VIAL	injectable · intravenous	ACCORD HLTHCARE	Prescription	27 Feb 2017
DECITABINE	50MG/VIAL	injectable · intravenous	PHARMASCIENCE INC	Prescription	31 May 2017
DECITABINE	50MG/VIAL	injectable · intravenous	CHEMI SPA	Prescription	22 Sep 2017
DECITABINE	50MG/VIAL	injectable · intravenous	SAGENT PHARMS INC	Prescription	16 Mar 2018
DECITABINE	50MG/VIAL	injectable · intravenous	WOCKHARDT BIO AG	Prescription	9 Apr 2019
DECITABINE	50MG/VIAL	injectable · intravenous	MSN	Prescription	28 Aug 2019
DECITABINE	50MG/VIAL	injectable · intravenous	GLAND	Prescription	23 Nov 2020
DECITABINE	50MG/VIAL	injectable · intravenous	NIVAGEN	Prescription	7 Dec 2020
DECITABINE	50MG/VIAL	injectable · intravenous	QILU PHARM HAINAN	Prescription	12 Apr 2021
DECITABINE	50MG/VIAL	injectable · intravenous	MEITHEAL	Prescription	2 Jul 2021
DECITABINE	50MG/VIAL	injectable · intravenous	ZYDUS PHARMS	Prescription	19 Nov 2021
DECITABINE	50MG/VIAL	injectable · intravenous	JIANGSU HANSOH PHARM	Prescription	15 Apr 2022
DECITABINE	50MG/VIAL	injectable · intravenous	HETERO LABS LTD VI	Prescription	10 May 2024
DECITABINE	50MG/VIAL	injectable · intravenous	RELIANCE LIFE SCI	Prescription	19 Dec 2025
DACOGEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · intravenous	OTSUKA	Discontinued	2 May 2006
DECITABINE	50MG/VIAL	powder · intravenous	SUN PHARM	Discontinued	23 Jan 2014
DECITABINE	50MG/VIAL	injectable · intravenous	CIPLA	Discontinued	16 Nov 2017
DECITABINE	50MG/VIAL	injectable · intravenous	LUPIN	Discontinued	9 Nov 2018
DECITABINE	50MG/VIAL	injectable · intravenous	INGENUS PHARMS LLC	Discontinued	16 Sep 2019
DECITABINE	50MG/VIAL	injectable · intravenous	EUGIA PHARMA	Discontinued	20 Sep 2021

EMA European Union — centrally authorised medicines

Dacogen · Authorised · authorised 20 Sep 2012 · ATC L01BC08

Therapeutic indication (EMA)

Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DEMYLOCAN	02484811	50 MG / VIAL	POWDER · INTRAVENOUS	PENDOPHARM DIVISION OF PHARMASCIENCE INC

Safety signals and safety-related labeling changes

US FDA 13 May 2026 INQOVI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Sep 2020 DECITABINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Jun 2020 DACOGEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 7 May 2015 PRAC signal: Organising pneumonia
Action for MAH: update of the product information: No

All safety entries for decitabine →

Combinations containing Decitabine

Cedazuridine + decitabine

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.