EPARs - Exjade//deferasirox

FICHA FARMACOLÓGICA de deferasirox. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. ABRIL 06, 2009.

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EPARs for authorised medicinal products for human use - Exjade

Active Substance
deferasirox
International Nonproprietary Name or Common Name
deferasirox
Pharmaco-therapeutic Group
Iron chelating agents
ATC Code
V03AC03

Therapeutic Indication:
Exjade 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.
EXJADE 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 patients with other anaemias,
-in patients aged 2 to 5 years,
-in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells).

Date of issue of Marketing Authorisation valid throughout the European Union
28 August 2006

Orphan medicinal product designation date
13 March 2002