Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: V03AC03

Deferasirox Mylan(deferasirox)

Iron Overload;beta-Thalassemia

Marketing Authorisation Holder: Mylan Pharmaceuticals Limited

EMA Authorisation: 26/09/2019

INN: deferasirox

Indication

Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (?7 ml/kg/month of packed red blood cells) aged 2 to 5 years, in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, in adult and paediatric patients with other anaemias aged 2 years and older. the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion dependent thalassaemia syndromes aged 10 years and older.

Official EMA Resources

View on EMA (ema.europa.eu)

AI Drug & Interaction Analysis

Free account required

Ask Prognia AI about Deferasirox Mylan — 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.