Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: L01BC07

Azacitidine Accord(azacitidine)

Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, Acute

Marketing Authorisation Holder: Accord Healthcare S.L.U.

EMA Authorisation: 13/02/2020

INN: azacitidine

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.

Official EMA Resources

View on EMA (ema.europa.eu)

AI Drug & Interaction Analysis

Free account required

Ask Prognia AI about Azacitidine Accord — dosing recommendations, drug interactions, and current guideline evidence from ESC, EMA, NICE and more.

Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.