União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrose cística - outros produtos do sistema respiratório - 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 e 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 e 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.

União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - fibrose cística - outros produtos do sistema respiratório - 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.

União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrose cística - outros produtos do sistema respiratório - 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.

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

vertex farmaceutica do brasil ltda. - ivacaftor, lumacaftor - outros produtos para o sistema respiratÓrio

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

vertex farmaceutica do brasil ltda. - ivacaftor - outros produtos para o aparelho respiratorio

União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibrose cística - outros produtos do sistema respiratório - orkambi comprimidos são indicados para o tratamento da fibrose cística (fc) em pacientes com idade entre 6 anos e mais velhos que são homozigotos para a mutação f508del no gene 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.

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

vertex farmaceutica do brasil ltda. - elexacaftor, tezacaftor, ivacaftor - outros produtos para o aparelho respiratorio

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

vertex farmaceutica do brasil ltda. - lumacaftor, ivacaftor - outros produtos para o aparelho respiratorio

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

vertex farmaceutica do brasil ltda. - ivacaftor, tezacaftor - outros produtos para o aparelho respiratorio

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

vertex farmaceutica do brasil ltda. - ivacaftor - outros produtos para o aparelho respiratorio