European Union - English - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - other alimentary tract and metabolism products, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

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

origin biosciences, inc. - fosdenopterin hydrobromide (unii: x41b5w735t) (fosdenopterin - unii:4x7k2681y7) - nulibry is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (mocd) type a. none. risk summary there are no available data on nulibry use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction toxicology studies have not been conducted with fosdenopterin. 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 are 2% to 4% and 15% to 20%, respectively. risk summary there are no human or animal data available to assess the presence of nulibry or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production for the mother. the developmental and health benefi

Israel - English - Ministry of Health

medison pharma ltd - fosdenopterin hydrobromide - powder for reconstitution for solution for injection - fosdenopterin hydrobromide 9.5 mg/vial - fosdenopterin - nulibry is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (mocd) type a.

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

sentynl therapeutics, inc. - fosdenopterin hydrobromide (unii: x41b5w735t) (fosdenopterin - unii:4x7k2681y7) - nulibry is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (mocd) type a. none. risk summary there are no available data on nulibry use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction toxicology studies have not been conducted with fosdenopterin. 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 are 2% to 4% and 15% to 20%, respectively. risk summary there are no human or animal data available to assess the presence of nulibry or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production for the mother. the developmental and health benefi