Deferasirox Accord (deferasirox)
- Region
- 🇪🇺 EU
- Active substance
- deferasirox
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Iron Overload; beta-Thalassemia
- EU approval
- Thu 09 Jan 2020
- Designations
- Generic
- Application
- EMEA/H/C/005156
- ATC
- V03AC03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Exjade Authorised · Novartis Europharm Limited
- 🇪🇺 Deferasirox Mylan Authorised · Mylan Pharmaceuticals Limited
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