Canada - English - Health Canada

alnylam netherlands b.v. - lumasiran (lumasiran sodium) - solution - 94.5mg - lumasiran (lumasiran sodium) 94.5mg

European Union - English - EMA (European Medicines Agency)

alnylam netherlands b.v. - lumasiran sodium - hyperoxaluria, primary - other alimentary tract and metabolism products, - treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

Israel - English - Ministry of Health

medison pharma ltd - lumasiran as sodium - solution for injection - lumasiran as sodium 189 mg / 1 ml - lumasiran - oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

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

alnylam pharmaceuticals, inc. - lumasiran (unii: rzt8c352o1) (lumasiran - unii:rzt8c352o1) - oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (ph1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see clinical pharmacology (12.1), clinical studies (14.1, 14.2, 14.3)] . none. risk summary there are no available data with the use of oxlumo in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. no adverse effects on pregnancy or embryo-fetal development related to oxlumo were observed in rats at 45 times and in rabbits at 90 times the maximum recommended human dose in women (see data ). the estimated background risk of major birth defects and miscarriage in 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. data animal data in an emb

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

arrotex pharmaceuticals pty ltd - lurasidone hydrochloride, quantity: 80 mg - tablet, film coated - excipient ingredients: hypromellose; maize starch; mannitol; croscarmellose sodium; magnesium stearate; titanium dioxide; macrogol 8000; iron oxide yellow; indigo carmine aluminium lake - apo-lurasidone is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

arrotex pharmaceuticals pty ltd - lurasidone hydrochloride, quantity: 40 mg - tablet, film coated - excipient ingredients: hypromellose; maize starch; mannitol; croscarmellose sodium; magnesium stearate; titanium dioxide; macrogol 8000 - apo-lurasidone is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

lupin australia pty limited - lurasidone hydrochloride, quantity: 20 mg - tablet, film coated - excipient ingredients: hypromellose; mannitol; magnesium stearate; croscarmellose sodium; titanium dioxide; macrogol 6000 - lurasidone lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

lupin australia pty limited - lurasidone hydrochloride, quantity: 40 mg - tablet, film coated - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; mannitol; titanium dioxide; macrogol 6000 - lurasidone lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

lupin australia pty limited - lurasidone hydrochloride, quantity: 80 mg - tablet, film coated - excipient ingredients: mannitol; hypromellose; magnesium stearate; croscarmellose sodium; titanium dioxide; iron oxide yellow; macrogol 6000; indigo carmine aluminium lake - lurasidone lupin is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

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

arrotex pharmaceuticals pty ltd - lurasidone hydrochloride, quantity: 20 mg - tablet, film coated - excipient ingredients: hypromellose; maize starch; mannitol; croscarmellose sodium; magnesium stearate; titanium dioxide; macrogol 8000 - apo- lurasidone is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).