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

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).

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.

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.

Canada - English - Health Canada

alexion pharma gmbh - sebelipase alfa - solution - 2mg - sebelipase alfa 2mg - enzymes

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

alexion pharma uk ltd - sebelipase alfa - solution for infusion - 2mg/1ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

alexion europe sas, france - sebelipase alfa - concentrate for solution for infusion - 2 mg/ml

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

actelion pharmaceuticals us, inc. - selexipag (unii: 5exc0e384l) (selexipag - unii:5exc0e384l) - selexipag 200 ug - uptravi is indicated for the treatment of pulmonary arterial hypertension (pah, who group i) to delay disease progression and reduce the risk of hospitalization for pah. effectiveness of uptravi tablets was established in a long-term study in pah patients with who functional class ii–iii symptoms. patients had idiopathic and heritable pah (58%), pah associated with connective tissue disease (29%), pah associated with congenital heart disease with repaired shunts (10%) [see clinical studies (14.1)] . hypersensitivity to the active substance or to any of the excipients. concomitant use of strong inhibitors of cyp2c8 (e.g., gemfibrozil) [see drug interactions (7.1) and clinical pharmacology (12.3)] . risk summary there are no adequate and well-controlled studies with uptravi in pregnant women. animal reproduction studies performed with selexipag showed no clinically relevant effects on embryofetal developmen

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

janssen-cilag pty ltd - selexipag, quantity: 800 microgram - tablet, film coated - excipient ingredients: hyprolose; iron oxide black; carnauba wax; titanium dioxide; maize starch; hypromellose; mannitol; propylene glycol; magnesium stearate; iron oxide yellow - uptravi is indicated for the treatment of:,- idiopathic pulmonary arterial hypertension;,- heritable pulmonary arterial hypertension;,- pulmonary arterial hypertension associated with connective tissue disease;,-pulmonary arterial hypertension associated with congenital heart disease with repaired shunts;,-pulmonary arterial hypertension associated with drugs and toxins;,in patients with who functional class ii, iii or iv symptoms

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

janssen-cilag pty ltd - selexipag, quantity: 1400 microgram - tablet, film coated - excipient ingredients: mannitol; maize starch; hyprolose; hypromellose; propylene glycol; magnesium stearate; titanium dioxide; carnauba wax; iron oxide yellow - uptravi is indicated for the treatment of:,- idiopathic pulmonary arterial hypertension;,- heritable pulmonary arterial hypertension;,- pulmonary arterial hypertension associated with connective tissue disease;,-pulmonary arterial hypertension associated with congenital heart disease with repaired shunts;,-pulmonary arterial hypertension associated with drugs and toxins;,in patients with who functional class ii, iii or iv symptoms