Exjade (deferasirox)
- Region
- 🇪🇺 EU
- Active substance
- deferasirox
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- beta-Thalassemia; Iron Overload
- CHMP opinion
- Wed 28 Jun 2006
- EU approval
- Mon 28 Aug 2006
- Designations
- Additional monitoring
- Application
- EMEA/H/C/000670
- ATC
- V03AC03
- Official record
- www.ema.europa.eu
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 six 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 beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged two to five years; in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged two years and older; in patients with other anaemias aged two years and older. Exjade 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Deferasirox Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Deferasirox Mylan Authorised · Mylan Pharmaceuticals Limited
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