New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 2000 [iu] (in 0.3ml) - solution for injection - 2000 iu/0.3ml - active: epoetin beta 2000 [iu] (in 0.3ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection - - for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks - for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 3000 [iu] (in 0.3ml) - solution for injection - 3000 iu/0.3ml - active: epoetin beta 3000 [iu] (in 0.3ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection - - for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks - for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 4000 [iu] (in 0.3ml) - solution for injection - 4000 iu/0.3ml - active: epoetin beta 4000 [iu] (in 0.3ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection - - for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks - for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 5000 [iu] (in 0.3 ml) - solution for injection - 5000 iu/0.3ml - active: epoetin beta 5000 [iu] (in 0.3 ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection - - for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks - for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 500 [iu] (in 0.3ml) - solution for injection - 500 iu/0.3ml - active: epoetin beta 500 [iu] (in 0.3ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 6000 [iu] (in 0.3ml) - solution for injection - 6000 iu/0.3ml - active: epoetin beta 6000 [iu] (in 0.3ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection - - for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks - for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - methoxy polyethylene glycol-epoetin beta - anemia; kidney failure, chronic - antianemic preparations - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5.1).treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.1).

European Union - English - EMA (European Medicines Agency)

hexal ag - epoetin alfa - anemia; kidney failure, chronic; cancer - antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. , treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).,

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - epoetin beta - solution for injection - 1667unit/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - epoetin beta - solution for injection - 3333unit/1ml