Basic Information
Azacitidine Accord
Regulatory Information
EMEA/H/C/005147
February 13, 2020
December 12, 2019
9
February 18, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
Azacitidine Accord 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 Accord is used in patients with an intermediate to high risk of progressing to AML or death; - chronic myelomonocytic leukaemia (a cancer affecting white blood cells called monocytes). Azacitidine Accord 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 Accord contains the active substance azacitidine. Azacitidine Accord is a ‘generic medicine’. This means that Azacitidine Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Vidaza. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf).