Deferasirox Mylan (deferasirox)
- Region
- 🇪🇺 EU
- Active substance
- deferasirox
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Iron Overload; beta-Thalassemia
- CHMP opinion
- Thu 25 Jul 2019
- EU approval
- Thu 26 Sep 2019
- Designations
- Generic
- Application
- EMEA/H/C/005014
- ATC
- V03AC03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Deferasirox Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Exjade Authorised · Novartis Europharm Limited
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