Велика Британія - англійська - MHRA (Medicines & Healthcare Products Regulatory Agency)

actelion pharmaceuticals uk ltd - miglustat - capsule - 100mg

Панама - англійська - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

ethnor del istmo, s.a. - miglustat - miglustat....100 mg

Японія - англійська - すりの適正使用協議会 RAD-AR Council, Japan

janssen pharmaceutical k.k. - miglustat - white capsules, major axis: 14 mm, minor axis: 6.5 mm

Європейський Союз - англійська - EMA (European Medicines Agency)

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

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

actelion pharmaceuticals australia pty limited - miglustat -

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

actelion pharmaceuticals australia pty limited - miglustat -

США - англійська - NLM (National Library of Medicine)

amicus therapeutics us, llc - cipaglucosidase alfa (unii: 4sed7f4bsg) (cipaglucosidase alfa - unii:4sed7f4bsg) - pombiliti is indicated, in combination with opfolda, 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). pombiliti in combination with opfolda is contraindicated in pregnancy [see warnings and precautions (5.4) and use in specific populations (8.1)]. risk summary based on findings from animal reproduction studies, pombiliti in combination with opfolda 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 cipaglucosidase alfa-atga in combination with miglustat at 16-fold and 3-fold, respectively, the mrhd of pombiliti and opfolda based on plasma auc exposure. a no observed adverse effect level (noael) was not identified for the combination. in a pre- and post-

Австралія - англійська - 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).