Australia - English - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - sebelipase alfa, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; albumin - kanuma (sebelipase alfa rce) is indicated for long-term enzyme replacement therapy (ert) in patients of all ages with lysosomal acid lipase deficiency (lal-d).

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lipegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections - lonquex? is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

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

alexion pharmaceuticals, inc. - sebelipase alfa (unii: k4ytu42t8g) (sebelipase alfa - unii:k4ytu42t8g) - sebelipase alfa 2 mg in 1 ml - kanuma® is indicated for the treatment of patients with a diagnosis of lysosomal acid lipase (lal) deficiency. none. risk summary available data with kanuma use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. animal reproductive studies conducted with sebelipase alfa showed no evidence of embryolethality, fetotoxicity, teratogenicity, or abnormal early embryonic development at dosages up to 164 and 526 times the human dosage of 1 mg/kg every other week (based on auc) in rats and rabbits, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. animal data sebelipase alfa administered during the period of organogenesis to rats (on gestation days 6, 9, 12, 15 and 17) and rabbits

European Union - English - EMA (European Medicines Agency)

alexion europe sas - sebelipase alfa - lipid metabolism, inborn errors - other alimentary tract and metabolism products, - kanuma is indicated for long-term enzyme replacement therapy (ert) in patients of all ages with lysosomal acid lipase (lal) deficiency.

European Union - English - EMA (European Medicines Agency)

lipomed gmbh - deferiprone - iron overload; beta-thalassemia - all other therapeutic products - deferiprone lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.deferiprone lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.

European Union - English - EMA (European Medicines Agency)

lipomed gmbh - thalidomide - multiple myeloma - immunosuppressants - thalidomide lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.thalidomide lipomed is prescribed and dispensed in accordance with the thalidomide lipomed pregnancy prevention programme (see section 4.4).

Philippines - English - FDA (Food And Drug Administration)

jw healthcare philippines corporation - lipid emulsion , amino acids , electrolytes , glucose - emulsion for iv infusion - [see reverse]

Israel - English - Ministry of Health

abic marketing ltd, israel - lipegfilgrastim - solution for injection - lipegfilgrastim 6 mg / 0.6 ml - lipegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Israel - English - Ministry of Health

alexion pharma israel ltd - sebelipase alfa - concentrate for solution for infusion - sebelipase alfa 2 mg / 1 ml - sebelipase alfa - kanuma is indicated for long-term enzyme replacement therapy (ert) in patients of all ages with lysosomal acid lipase (lal) deficiency.

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

allergan, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - pancrelipase lipase 3000 [usp'u] - zenpep® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. none. risk summary published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. animal reproduction studies have not been conducted with pancrelipase. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary there are no data on the presence of pancrelipase in either human or animal milk, the effects