Miglustatas - search results

New Zealand - English - Medsafe (Medicines Safety Authority)

zavesca

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)

cerdelga

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

zavesca capsule

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

Canada - English - Health Canada

cerdelga capsule

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)

opfolda- miglustat capsule

amicus therapeutics us, llc - miglustat (unii: adn3s497az) (miglustat - unii:adn3s497az) - opfolda is indicated, in combination with pombiliti, for the treatment of adult patients with late-onset pompe disease (lysosomal acid alpha-glucosidase [gaa] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ert). opfolda in combination with pombiliti is contraindicated in pregnancy [see use in specific populations (8.1)] risk summary based on findings from animal reproduction studies, opfolda in combination with pombiliti may cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy. in a rabbit embryo-fetal development study, great vessel and cardiac malformations were increased in offspring of pregnant rabbits treated with miglustat in combination with cipaglucosidase alfa-atga at 3-fold and 16-fold, respectively, the mrhd of opfolda and pombiliti based on plasma auc exposure. a no observed adverse effect level (noael) was not identified for the combination. in a pre- and post-natal development study in rats, inc