Israel - English - Ministry of Health

teva israel ltd - deferasirox - tablets dispersible - deferasirox 125 mg - deferasirox - deferasirox teva is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over). deferasirox teva is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older. chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [lic] ≥5 mg fe/g dry weight [dw] or serum ferritin consistently >800 μg /l).lic is the preferred method of iron overload determination and should be used wherever available.

Israel - English - Ministry of Health

teva israel ltd - deferasirox - tablets dispersible - deferasirox 250 mg - deferasirox - deferasirox teva is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over). deferasirox teva is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older. chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [lic] ≥5 mg fe/g dry weight [dw] or serum ferritin consistently >800 μg /l).lic is the preferred method of iron overload determination and should be used wherever available.

Israel - English - Ministry of Health

teva israel ltd - deferasirox - tablets dispersible - deferasirox 500 mg - deferasirox - deferasirox teva is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over). deferasirox teva is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older. chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [lic] ≥5 mg fe/g dry weight [dw] or serum ferritin consistently >800 μg /l).lic is the preferred method of iron overload determination and should be used wherever available.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasirox - iron overload; beta-thalassemia - iron chelating agents - deferasirox mylan is indicated forthe 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 olderthe 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 (

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - deferasirox - iron overload; beta-thalassemia - all other therapeutic products, iron chelating agents - 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 (

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. deferasirox tablets for oral suspension are contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; - poor performance status; [see warnings and precautions (5.1, 5.3)] - high-risk myelodysplastic syndromes; (this patient population was

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: • estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; • poor performance status [see warnings and precautions (5.1, 5.3)]; • high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy);

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s exjade® (deferasirox) tablets for oral suspension. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. deferasirox tablets for oral suspension are contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; - poor performance status; [see warnings and precautions (5.1, 5.3)] - high-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelatio

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox when administered with other iron chelation therapy have not been  established. deferasirox  is contraindicated in patients with: ·         estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; ·         poor performance status; [see warnings and precautions (5.1, 5.3)] ·         high-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelation th