Evropská unie - angličtina - EMA (European Medicines Agency)

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

Evropská unie - angličtina - EMA (European Medicines Agency)

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

Spojené státy - angličtina - 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

Jihoafrická republika - angličtina - South African Health Products Regulatory Authority (SAHPRA)

takeda (pty) ltd - infusion (parenteral) - see ingredients - each vial contains velaglucerase 400,0 units

Spojené státy - angličtina - 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

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

actelion pharmaceuticals australia pty limited - miglustat -

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - miglustat 100mg - capsule - 100 mg - active: miglustat 100mg excipient: gelatin magnesium stearate povidone sodium starch glycolate titanium dioxide - zavesca® is indicated for the treatment of progressive neurological manifestations in adult and paediatric patients with niemann-pick type c disease.

Evropská unie - angličtina - EMA (European Medicines Agency)

sanofi b.v. - eliglustat - gaucher disease - other alimentary tract and metabolism products, - 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).

Kanada - angličtina - Health Canada

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

Kanada - angličtina - Health Canada

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