Union européenne - français - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrose kystique - autres produits du système respiratoire - 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 et 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 et 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.

Union européenne - français - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrose kystique - autres produits du système respiratoire - 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.

Union européenne - français - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, l'ivacaftor - fibrose kystique - autres produits du système respiratoire - orkambi comprimés est indiqué pour le traitement de la fibrose kystique (fk) chez les patients âgés de 6 ans et plus qui sont homozygotes pour la mutation f508del du gène cftr. 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.

Union européenne - français - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, l'ivacaftor - fibrose kystique - autres produits du système respiratoire - 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.

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - ivacaftorum - comprimés pelliculés - 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. - la mucoviscidose - synthetika

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - lumacaftorum, ivacaftorum - comprimés pelliculés - lumacaftorum 200 mg, ivacaftorum 125 mg, hypromellosi acetas succinas, natrii laurilsulfas, cellulosum microcristallinum, carmellosum natricum conexum, povidonum k 30, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, e 120, e 132, e 133, e 171, drucktinte: lacca, e 172 (nigrum), propylenglycolum, ammonii hydroxidum, pro compresso obducto corresp. natrium 3.51 mg. - la mucoviscidose - synthetika

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - lumacaftorum, ivacaftorum - comprimés pelliculés - lumacaftorum 100 mg, ivacaftorum 125 mg, hypromellosi acetas succinas, natrii laurilsulfas, cellulosum microcristallinum, carmellosum natricum conexum, povidonum k 30, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, e 120, e 132, e 133, e 171, drucktinte: lacca, e 172 (nigrum), propylenglycolum, ammonii hydroxidum pro compresso obducto corresp. natrium 2.56 mg. - la mucoviscidose - synthetika

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

vertex pharmaceuticals (ch) gmbh - tezacaftorum, ivacaftorum - comprimés pelliculés - 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. - traitement de la fibrose kystique - synthetika

Suisse - français - 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. - la mucoviscidose - synthetika

Suisse - français - 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. - la mucoviscidose - synthetika