Kalydeco Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

kalydeco

vertex pharmaceuticals (ireland) limited - ivacaftor - cystic fibrosis - other respiratory system products - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4.4 and 5.1).in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5.1).kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4.4 and 5.1).in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Orkambi Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

orkambi

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystic fibrosis - other respiratory system products - orkambi tablets are indicated for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who are homozygous for the f508del mutation in the cftr gene.orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

INCIVEK TABLET Կանադա - անգլերեն - Health Canada

incivek tablet

vertex pharmaceuticals (canada) incorporated - telaprevir - tablet - 375mg - telaprevir 375mg - hcv antivirals

KALYDECO TABLET Կանադա - անգլերեն - Health Canada

kalydeco tablet

vertex pharmaceuticals (canada) incorporated - ivacaftor - tablet - 150mg - ivacaftor 150mg - cystic fibrosis transmembrane conductance regulator potentiators

KALYDECO GRANULES Կանադա - անգլերեն - Health Canada

kalydeco granules

vertex pharmaceuticals (canada) incorporated - ivacaftor - granules - 50mg - ivacaftor 50mg - cystic fibrosis transmembrane conductance regulator potentiators

KALYDECO GRANULES Կանադա - անգլերեն - Health Canada

kalydeco granules

vertex pharmaceuticals (canada) incorporated - ivacaftor - granules - 75mg - ivacaftor 75mg - cystic fibrosis transmembrane conductance regulator potentiators

ORKAMBI TABLET Կանադա - անգլերեն - Health Canada

orkambi tablet

vertex pharmaceuticals (canada) incorporated - ivacaftor; lumacaftor - tablet - 125mg; 200mg - ivacaftor 125mg; lumacaftor 200mg - cystic fibrosis transmembrane conductance regulator correctors

ORKAMBI TABLET Կանադա - անգլերեն - Health Canada

orkambi tablet

vertex pharmaceuticals (canada) incorporated - ivacaftor; lumacaftor - tablet - 125mg; 100mg - ivacaftor 125mg; lumacaftor 100mg - cystic fibrosis transmembrane conductance regulator correctors