Prognia
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🇪🇺EU · EMAAuthorisedATC: V03AC03

Deferasirox Accord(deferasirox)

Iron Overload;beta-Thalassemia

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

EMA Authorisation: 09/01/2020

INN: deferasirox

Indication

Deferasirox Accord 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. Deferasirox Accord is also indicated for 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. Deferasirox Accord is also indicated for 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)

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