New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - velaglucerase alfa 400 u;   - powder for infusion concentrate - 400 u - active: velaglucerase alfa 400 u   excipient: citric acid monohydrate polysorbate 20 sodium citrate dihydrate sucrose - vpriv is indicated for long-term enzyme replacement therapy (ert) for paediatric and adult patients with type i gaucher disease.

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

sanofi-aventis australia pty ltd - eliglustat tartrate, quantity: 100 mg (equivalent: eliglustat, qty 84.4 mg) - capsule, hard - excipient ingredients: lactose monohydrate; hypromellose; microcrystalline cellulose; glycerol dibehenate; iron oxide yellow; gelatin; indigo carmine aluminium lake; titanium dioxide; mica; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - cerdelga is indicated for the long-term treatment of adult patients with gaucher disease type 1 (gd1).

Canada - English - Health Canada

janssen inc - miglustat - capsule - 100mg - miglustat 100mg - other miscellaneous therapeutic agents

Canada - English - Health Canada

takeda canada inc - velaglucerase alfa - powder for solution - 400unit - velaglucerase alfa 400unit - enzymes

Canada - English - Health Canada

pfizer canada ulc - taliglucerase alfa - powder for solution - 200unit - taliglucerase alfa 200unit - enzymes

Canada - English - Health Canada

sandoz canada incorporated - miglustat - capsule - 100mg - miglustat 100mg - other miscellaneous therapeutic agents

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - eliglustat (eliglustat tartrate) - capsule - 84mg - eliglustat (eliglustat tartrate) 84mg - other miscellaneous therapeutic agents

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

takeda pharmaceuticals america, inc. - velaglucerase alfa (unii: 23hye36b0i) (velaglucerase alfa - unii:23hye36b0i) - velaglucerase alfa 2.5 mg in 1 ml - vpriv is indicated for long-term enzyme replacement therapy (ert) for patients with type 1 gaucher disease. none. risk summary available data on use of velaglucerase alfa in pregnant women includes more than 300 pregnancies reported from the pharmacovigilance database and published observational cohort studies, including the international gaucher disease registry. while available data cannot definitively establish or exclude the absence of a velaglucerase alfa associated risk during pregnancy, these data have not identified an association with use of velaglucerase alfa during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies no fetal harm was observed in rats or rabbits when velaglucerase alfa was administered intravenously during organogenesis at doses with exposures up to 1.8 times and 4.3 times, respectively, the recommended human daily dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicate

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

pfizer laboratories div pfizer inc - taliglucerase alfa (unii: 0r4nlx88o4) (taliglucerase alfa - unii:0r4nlx88o4) - taliglucerase alfa 200 u in 5 ml - elelyso is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of type 1 gaucher disease. none. risk summary the limited available data on elelyso use in pregnant women are not sufficient to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . in animal reproduction studies when pregnant rats and rabbits were administered taliglucerase alfa at intravenous doses up to 5 times the recommended human dose (rhd), there was no evidence of embryo-fetal toxicity [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) are 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. clinical considerations disease-associated maternal and/or embryo/fetal risk women with type 1 gaucher disease have an increased risk of spontaneous abortion if diseas

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

actelion pharmaceuticals us, inc. - miglustat (unii: adn3s497az) (miglustat - unii:adn3s497az) - miglustat 100 mg - zavesca is indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 gaucher disease for whom enzyme replacement therapy is not a therapeutic option (e.g. due to allergy, hypersensitivity, or poor venous access). none. risk summary based on findings from animal reproduction studies, zavesca may cause fetal harm when administered to a pregnant woman. available data from postmarketing case reports with zavesca use in pregnancy are insufficient to assess a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks associated with symptomatic type i gaucher disease in pregnancy, including hepatosplenomegaly and thrombocytopenia (see clinical considerations). advise pregnant women of the potential risks to the fetus. in animal reproduction studies, miglustat was maternally toxic in rabbits at exposures near the expected human therapeutic dose and caused embryo-fetal toxicitie