USA - engelska - NLM (National Library of Medicine)

sun pharmaceutical industries, 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 m 2 [see dosage and administration (2.5), warnings and precautions (5.1)]; - poor performance status [see warnings and precautions (5.1, 5.3)] ; - high-risk myelodyspl

USA - engelska - NLM (National Library of Medicine)

northstar rx llc. - 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. this indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg fe/g dw) and serum ferritin levels [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 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: -   esti

USA - engelska - NLM (National Library of Medicine)

cipla usa inc. - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablet is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablet 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 tablet 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 therapy) ; -   advanced ma

USA - engelska - NLM (National Library of Medicine)

ascend laboratories, llc - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox oral granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox oral granules 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. this indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg fe/g dw) and serum ferritin levels [see clinical studies (14)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. the safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. deferasirox is contraindicated in patients with: - estimated gf

USA - engelska - NLM (National Library of Medicine)

celltrion usa, 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) ; - advance

USA - engelska - NLM (National Library of Medicine)

cipla usa inc. - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox granules 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 when administered with other iron chelation therapy have not been established. deferasirox granules 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) ; - advanced m

USA - engelska - NLM (National Library of Medicine)

aurobindo pharma limited - 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) ; - advance

USA - engelska - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox oral granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox oral granules 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 oral granules when administered with other iron chelation therapy have not been established. deferasirox oral granules are contraindicated in patients with: • estimated gfr less than 40 ml/min/1.73 m 2 [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 popul

Israel - engelska - 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 - engelska - 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.