Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - ivacaftorum - filmtabletten - ivacaftorum 150 mg, hypromellosi acetas succinas, natrii laurilsulfas, cellulosum microcristallinum, lactosum monohydricum 167.2 mg, carmellosum natricum conexum, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), e 171, macrogolum 3350, talcum, e 132, cera carnauba, drucktinte: lacca, e 172 (nigrum), propylenglycolum, ammonii hydroxidum, pro compresso obducto corresp. natrium 1.82 mg. - mukoviszidose - synthetika

Europäische Union - Deutsch - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - mukoviszidose - andere produkte für die atemwege - 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 und 5. 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. 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 und 5. 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.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - ivacaftorum - granulat - ivacaftorum 50 mg, hypromellosi acetas succinas, natrii laurilsulfas, lactosum monohydricum 73.2 mg, mannitolum, sucralosum, carmellosum natricum conexum, silica colloidalis anhydrica, magnesii stearas ad granulatum pro charta corresp. natrium 0.99 mg. - mukoviszidose - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - ivacaftorum - granulat - ivacaftorum 75 mg, hypromellosi acetas succinas, natrii laurilsulfas, lactosum monohydricum 109.8 mg, mannitolum, sucralosum, carmellosum natricum conexum, silica colloidalis anhydrica, magnesii stearas ad granulatum pro charta corresp. natrium 1.49 mg. - mukoviszidose - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - ivacaftorum - granulat - ivacaftorum 25 mg, hypromellosi acetas succinas, natrii laurilsulfas, lactosum monohydricum 36.6 mg, mannitolum, sucralosum, carmellosum natricum conexum, silica colloidalis anhydrica, magnesii stearas ad granulatum pro charta corresp. natrium 0.5 mg. - mukoviszidose - synthetika