Basic Information
Azacitidine betapharm
Regulatory Information
EMEA/H/C/005075
March 24, 2020
January 30, 2020
6
January 10, 2024
Company Information
Germany
Kobelweg 95 86156 Augsburg
betapharm Arzneimittel GmbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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.
Overview Summary
Azacitidine betapharm is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient’s bone marrow is replaced to form new bone marrow that produces healthy cells): - myelodysplastic syndromes, a group of conditions where the bone marrow produces abnormal blood cells and not enough healthy ones. In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells). Azacitidine betapharm 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 betapharm 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, where the bone marrow consists of 20 to 30% abnormal cells; - AML, where the bone marrow has more than 30% abnormal cells. Azacitidine betapharm contains the active substance azacitidine. Azacitidine betapharm is a ‘generic medicine’. This means that Azacitidine betapharm contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Vidaza.