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).

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

janssen-cilag pty ltd - miglustat, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; povidone; sodium starch glycollate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide; industrial methylated spirit; ammonia; sorbitan monolaurate; gelatin; sodium lauryl sulfate - zavesca is indicated for the oral treatment of patients with mild to moderate type 1 gaucher disease, for whom enzyme replacement therapy is not a therapeutic option. zavesca is indicated for the treatment of the progressive neurological manifestations in adult and paediatric patients with niemann-pick type c disease.

Canada - English - Health Canada

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

Israel - English - Ministry of Health

j-c health care ltd - miglustat - capsules - miglustat 100 mg - miglustat - miglustat - zavesca is indicated for the oral treatment of mild to moderate type i gaucher disease. zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with niemann-pick type c disease.

Israel - English - Ministry of Health

sanofi israel ltd - eliglustat - hard capsule - eliglustat 84.4 mg - eliglustat - cerdelga is indicated for the long-term treatment of adult patients with gaucher disease type 1 (gd1), who are cyp2d6 poor metabolisers (pms), intermediate metabolisers (ims) or extensive metabolisers (ems).

European Union - English - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - glycogen storage disease type ii - other alimentary tract and metabolism products - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).

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

edenbridge pharmaceuticals llc. - miglustat (unii: adn3s497az) (miglustat - unii:adn3s497az) - yargesa 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, miglustat capsules may cause fetal harm when administered to a pregnant woman. available data from postmarketing case reports with miglustat capsules 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 toxicities in rats at doses twice the

European Union - English - EMA (European Medicines Agency)

piramal critical care b.v. - miglustat - gaucher disease - other alimentary tract and metabolism products, - yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 gaucher disease.yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with niemann-pick type c disease.

European Union - English - EMA (European Medicines Agency)

janssen cilag international nv - miglustat - gaucher disease; niemann-pick diseases - other alimentary tract and metabolism products, - zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 gaucher disease. zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with niemann-pick type-c disease.

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

edenbridge pharmaceuticals llc. - miglustat (unii: adn3s497az) (miglustat - unii:adn3s497az) - miglustat 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, miglustat capsules may cause fetal harm when administered to a pregnant woman. available data from postmarketing case reports with miglustat capsules 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 toxicities in rats at doses twice th