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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - mukoviszidose - andere produkte für die atemwege - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

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

vertex pharmaceuticals (ch) gmbh - lumacaftorum, ivacaftorum - granulat - lumacaftorum 100 mg, ivacaftorum 125 mg, hypromellosi acetas succinas, natrii laurilsulfas, carmellosum natricum conexum, cellulosum microcristallinum, povidonum k 30 ad granulatum pro charta corresp. natrium 0.89 mg. - mukoviszidose - synthetika

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

vertex pharmaceuticals (ch) gmbh - lumacaftorum, ivacaftorum - granulat - lumacaftorum 150 mg, ivacaftorum 188 mg, hypromellosi acetas succinas, natrii laurilsulfas, carmellosum natricum conexum, cellulosum microcristallinum, povidonum k 30 ad granulatum pro charta corresp. natrium 1.34 mg. - mukoviszidose - synthetika

Europäische Union - Deutsch - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - mukoviszidose - andere produkte für die atemwege - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (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.

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

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

vertex pharmaceuticals (ch) gmbh - elexacaftorum, tezacaftorum, ivacaftorum - 150 mg, filmtabletten - filmtablette morgendosis (elexacaftorum 100 mg / tezacaftorum 50 mg / ivacaftorum 75 mg): elexacaftorum 100 mg, tezacaftorum 50 mg, ivacaftorum 75 mg, hypromellosum, hypromellosi acetas succinas, natrii laurilsulfas, carmellosum natricum conexum, cellulosum microcristallinum, magnesii stearas, Überzug: hypromellosum, hydroxypropylcellulosum, e 171, talcum, e 172 (flavum), e 172 (rubrum) pro compresso obducto corresp. natrium 2.68 mg. filmtablette abenddosis (ivacaftorum 150 mg): 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

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

vertex pharmaceuticals (ch) gmbh - elexacaftorum, tezacaftorum, ivacaftorum - 75 mg, filmtabletten - filmtablette morgendosis (elexacaftorum 50 mg / tezacaftorum 25 mg / ivacaftorum 37.5 mg): elexacaftorum 50 mg, tezacaftorum 25 mg, ivacaftorum 37.5 mg, hypromellosum, hypromellosi acetas succinas, natrii laurilsulfas, carmellosum natricum conexum, cellulosum microcristallinum, magnesii stearas, Überzug: hypromellosum, hydroxypropylcellulosum, e 171, talcum, e 172 (flavum), e 172 (rubrum) pro compresso obducto corresp. natrium 1.34 mg. filmtablette abenddosis (ivacaftorum 75 mg): ivacaftorum 75 mg, hypromellosi acetas succinas, natrii laurilsulfas, cellulosum microcristallinum, lactosum monohydricum 83.6 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 0.9 mg. - mukoviszidose - synthetika

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

vertex pharmaceuticals (ch) gmbh - tezacaftorum, ivacaftorum - filmtabletten - filmtablette morgendosis (tezacaftorum 100 mg / ivacaftorum 150 mg): tezacaftorum 100 mg, ivacaftorum 150 mg, hypromellosi acetas succinas, natrii laurilsulfas, hypromellosum, cellulosum microcristallinum, carmellosum natricum conexum, magnesii stearas, Überzug: hypromellosum, hydroxypropylcellulosum, talcum, e 171, e 172 (flavum) pro compresso obducto corresp. natrium 2.74 mg. filmtablette abenddosis (ivacaftorum 150 mg): 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. - behandlung zystischer fibrose - synthetika

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

vertex pharmaceuticals (ch) gmbh - tezacaftorum, ivacaftorum - filmtabletten - filmtablette morgendosis (tezacaftorum 50 mg / ivacaftorum 75 mg): tezacaftorum 50 mg, ivacaftorum 75 mg, hypromellosi acetas succinas, natrii laurilsulfas, hypromellosum, cellulosum microcristallinum, carmellosum natricum conexum, magnesii stearas, Überzug: hypromellosum, hydroxypropylcellulosum, talcum, e 171 pro compresso obducto corresp. natrium 1.37 mg. filmtablette abenddosis (ivacaftorum 75 mg): ivacaftorum 75 mg, hypromellosi acetas succinas, natrii laurilsulfas, cellulosum microcristallinum, lactosum monohydricum 83.6 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 0.9 mg. - behandlung zystischer fibrose - synthetika