Is Azacitidine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Azacitidine, including AZACITIDINE NEAPOLIS (100 mg, Lyophilisate for solution for injection, SAR 884.80); AZACITIDINE SPC 100 MG INJECTION (100 mg, Powder for suspension for injection, SAR 810.20); Amleka 100 mg (100 mg, Powder for suspension for injection, SAR 884.80); Averaz (100 mg, Powder for suspension for injection, SAR 1041.65); Azacitidine Kabi (100 mg, Powder for injection, SAR 794.05).

Is Azacitidine approved by the US FDA?

Drugs@FDA lists 18 application product lines for Azacitidine, including VIDAZA (Prescription); AZACITIDINE (Prescription); AZACITIDINE (Prescription); AZACITIDINE (Prescription); AZACITIDINE (Prescription).

Is Azacitidine authorised in the European Union?

EMA lists 6 centrally authorised medicines containing Azacitidine: Vidaza, Azacitidine Accord, Azacitidine betapharm, Azacitidine Mylan, Onureg, Azacitidine Kabi.

Are there safety signals or safety updates for Azacitidine?

EMA PRAC: 6 entries; US FDA: 3 entries (latest 2026-04-09).

Active substance

Azacitidine

SFDA 11
US FDA 18
EMA 8
Health Canada 7
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AZACITIDINE NEAPOLIS	100 mg	Lyophilisate for solution for injection · Subcutaneous use	1 Vial	SAR 884.80	Generic · Prescription	LES LABORATORIES NEAPOLIS PHARMA	Valid
AZACITIDINE SPC 100 MG INJECTION	100 mg	Powder for suspension for injection · Intravenous, Subcutaneous	1 Vial	SAR 810.20	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Amleka 100 mg	100 mg	Powder for suspension for injection · Subcutaneous use	1 Vial	SAR 884.80	Generic · Prescription	Seacross Pharmaceuticals Ltd	Valid
Averaz	100 mg	Powder for suspension for injection · Intravenous, Subcutaneous	1 Vial	SAR 1041.65	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Azacitidine Kabi	100 mg	Powder for injection · Intravenous, Subcutaneous	1 Vial	SAR 794.05	Generic · Prescription	Fresenius Kabi Oncology Limited	Valid
Dazaspect	100 mg	Lyophilisate for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 880.00	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
Eztyd	100 mg	Powder for suspension for injection · Subcutaneous use	1 Vial	SAR 884.80	Generic · Prescription	Panacea Biotec Pharma Ltd	Valid
Tacidine	100 mg	Powder for suspension for injection · Subcutaneous use	1 Vial	SAR 899.55	Generic · Prescription	Accord Healthcare Limited	Valid
ZYTEDIN 100MG POWDER FOR INJECTION	100 mg	Powder for suspension for injection · Subcutaneous use	1 Vial	SAR 1041.65	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
VIDAZA 100 mg powder for suspension for injection	100 mg	Powder for suspension for injection · Subcutaneous use	1 Vial	SAR 1424.50	NCE · Prescription	CELGENE EUROPE Ltd	Withdrawn by MAH · Not Marketed
VIDAZA 100 mg powder for suspension for injection	100 mg	Powder for suspension for injection · Subcutaneous use	1 Vial	SAR 1424.50	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML); MYELODYSPLASTIC SYNDROMES; MYELOFIBROSIS-SYMPTOMATIC, LOW-RISK

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

Product	Strength	Form · route	Applicant	Status	First approved
VIDAZA	100MG/VIAL	powder · intravenous, subcutaneous	BRISTOL-MYERS	Prescription	19 May 2004
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	DR REDDYS	Prescription	16 Sep 2013
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	ACTAVIS LLC	Prescription	29 Apr 2016
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	ADAPTIS	Prescription	29 Sep 2016
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	NATCO PHARMA LTD	Prescription	23 Jun 2017
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	CIPLA	Prescription	4 May 2018
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	ACCORD HLTHCARE	Prescription	2 Jul 2018
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	EUROHLTH INTL SARL	Prescription	8 Jun 2020
ONUREG	200MG; 300MG	tablet · oral	BRISTOL	Prescription	1 Sep 2020
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	MEITHEAL	Prescription	2 Nov 2020
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	EUGIA PHARMA	Prescription	30 Dec 2022
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	JIANGSU HANSOH PHARM	Prescription	28 Jun 2023
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	MSN LABS PVT LTD	Prescription	16 May 2024
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	HETERO LABS LTD VI	Prescription	15 Oct 2024
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	RELIANCE LIFE	Prescription	20 May 2025
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	PHARMOBEDIENT	Discontinued	28 Apr 2016
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	LUPIN	Discontinued	27 Feb 2019
AZACITIDINE	100MG/VIAL	powder · intravenous, subcutaneous	AMNEAL	Discontinued	3 Feb 2022

EMA European Union — centrally authorised medicines

Vidaza Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 17 Dec 2008 · ATC L01BC07

Therapeutic indication (EMA)

Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification. Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.

Azacitidine Accord Accord Healthcare S.L.U. · Authorised · authorised 13 Feb 2020 · ATC L01BC07

Therapeutic indication (EMA)

Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: - intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), - chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder, - acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, - AML with >30% marrow blasts according to the WHO classification.

Azacitidine betapharm betapharm Arzneimittel GmbH · Authorised · authorised 24 Mar 2020 · ATC L01BC07

Therapeutic indication (EMA)

Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 % to 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30 % marrow blasts according to the WHO classification.

Azacitidine Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 27 Mar 2020 · ATC L01BC07

Therapeutic indication (EMA)

Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.

Onureg Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 17 Jun 2021 · ATC L01BC07

Therapeutic indication (EMA)

Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).

Azacitidine Kabi Fresenius Kabi Deutschland GmbH · Authorised · authorised 5 Jan 2024 · ATC L01BC07

Therapeutic indication (EMA)

Azacitidine Kabi is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation(HSCT) with: Intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the international prognostic scoring system (IPSS), Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.

Azacitidine Adienne Adienne S.r.l. S.U. · Application withdrawn · ATC L01BC07

Therapeutic indication (EMA)

Treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML).

Azacitidine Celgene Celgene Europe BV · Withdrawn · authorised 2 Aug 2019 · ATC L01BC07

Therapeutic indication (EMA)

Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, AML with >30% marrow blasts according to the WHO classification.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AZACITIDINE FOR INJECTION	02462826	100 MG / VIAL	POWDER FOR SUSPENSION · SUBCUTANEOUS	DR REDDY'S LABORATORIES LTD
AZACITIDINE FOR INJECTION	02505177	100 MG / VIAL	POWDER FOR SUSPENSION · SUBCUTANEOUS	FRESENIUS KABI CANADA LTD
AZACITIDINE FOR INJECTION	02507668	100 MG / VIAL	POWDER FOR SUSPENSION · SUBCUTANEOUS	HIKMA CANADA LIMITED
AZACITIDINE FOR INJECTION	02529599	100 MG / VIAL	POWDER FOR SUSPENSION · SUBCUTANEOUS	SANDOZ CANADA INCORPORATED
ONUREG	02510197	200 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
ONUREG	02510200	300 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
VIDAZA	02336707	100 MG / VIAL	POWDER FOR SUSPENSION · SUBCUTANEOUS	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

US FDA 9 Apr 2026 ONUREG — 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 19 Dec 2024 AZACITIDINE — 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 28 Jun 2024 VIDAZA — 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 28 Sep 2023 PRAC signal: Cutaneous vasculitis
Action for MAH: update of the product information: Yes
EMA PRAC 12 May 2023 PRAC signal: Cutaneous vasculitis
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2019 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 14 Jun 2019 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 12 Jan 2017 PRAC signal: Pericarditis and pericardial effusion
Action for MAH: update of the product information: Yes
EMA PRAC 2 Sep 2016 PRAC signal: Pericarditis and pericardial effusion
Action for MAH: update of the product information: No

All safety entries for azacitidine →

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.