European Union - English - 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.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

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

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

actelion pharmaceuticals australia pty limited - miglustat -

New Zealand - English - 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.

European Union - English - 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).

Canada - English - Health Canada

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

Canada - English - Health Canada

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

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.

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

sanofi - eliglustat tartrate - capsule - 84.4mg

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).