Azacitidine
Also known as: Vidaza · Onureg · Azacitidine Accord · Azacitidine betapharm · Azacitidine Mylan · Azacitidine Kabi
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, azacitidine as Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy and who are not candidates for hematopoietic stem cell transplantation. In the European Union, azacitidine as Vidaza is indicated for adult patients ineligible for haematopoietic stem cell transplantation who have intermediate-2 and high-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia, or acute myeloid leukaemia. In the United States, azacitidine for injection is a nucleoside metabolic inhibitor indicated for adult patients with specific French-American-British myelodysplastic syndrome subtypes. Azacitidine is listed by the cited source as having an approved use for myelodysplastic syndromes.
From: Source: European Medicines Agency (EMA), Onureg — EPAR, 03/09/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Vidaza — EPAR, 05/11/2024. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 1251 azacitidine
- EMA
- EMEA/H/C/000978, EMEA/H/C/004761, EMEA/H/C/005147, EMEA/H/C/005075, EMEA/H/C/004984, EMEA/H/C/006154
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
FDA (USA) Azacitidine
1 INDICATIONS AND USAGE Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). ( 1.1 ) 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Pediatric use information is approved for Celgene Corporation’s Vidaza (azacitidine for injection). However, due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information.
Data provided by the U.S. Food and Drug Administration.
Document date: 20260908 · Official document →
EMA (EU) Onureg
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).
Source: European Medicines Agency (EMA), Onureg — EPAR, 03/09/2026. © European Medicines Agency.
Document date: 03/09/2026 · Official document →
EMA (EU) Vidaza
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.
Source: European Medicines Agency (EMA), Vidaza — EPAR, 05/11/2024. © European Medicines Agency.
Document date: 05/11/2024 · Official document →
Related terms in the cited sources
Has an official indication for
- Myelodysplastic Syndromes Condition
In alphabetical order.
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Azacitidine approved for in the European Union?
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). (Source: European Medicines Agency (EMA), Onureg — EPAR, 03/09/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Onureg — EPAR, 03/09/2026. © European Medicines Agency.
- Source: European Medicines Agency (EMA), Vidaza — EPAR, 05/11/2024. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
In an emergency, call 112 (or your local emergency number). Do not delay seeking medical help because of something you read here.