Azacitidine Celgene is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow’s ability to produce healthy blood cells):
- myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine Celgene is used in patients with an intermediate to high risk of progressing to AML or death;
- chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes). Azacitidine Celgene is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
- AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
- AML, when the bone marrow has more than 30% abnormal cells.
Azacitidine Celgene contains the active substance azacitidine.
This medicine is the same as Vidaza, which is already authorised in the EU. The company that makes Vidaza has agreed that its scientific data can be used for Azacitidine Celgene (‘informed consent’).
Azacitidine Celgene : EPAR - Medicine overview (PDF/77.17 KB)
First published: 14/08/2019
Azacitidine Celgene : EPAR - Risk-management-plan summary (PDF/118.54 KB)
First published: 14/08/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Celgene Europe BV
|Date of issue of marketing authorisation valid throughout the European Union||
02/08/2019 Azacitidine Celgene - EMEA/H/C/005300 -
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.