Unión Europea - español - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrosis quística - otros productos del sistema respiratorio - 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.

Unión Europea - español - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrosis quística - otros productos del sistema respiratorio - 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 y 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 y 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.

Chile - español - ISPC (Instituto de Salud Pública de Chile)

vertex pharmaceuticals (chile) s.p.a. - elexacaftor; ivacaftor; tezacaftor - elexacaftor 100,00 mg núcleo del comprimido recubierto naranja; ivacaftor 75,00 mg núcleo del comprimido recubierto naranja; ivacaftor 187,50 mg núcleo del comprimido recubierto celeste; tezacaftor 50,00 mg núcleo del comprimido recubierto naranja - indicado para el tratamiento de la fibrosis quística (fq) en pacientes mayores de 6 años que tienen al menos una mutación f508del en el gen regulador de la conductancia transmembrana de la fibrosis quística (cftr) o una mutación en el gen cftr que sea susceptible a responder, según datos in vitro.

Chile - español - ISPC (Instituto de Salud Pública de Chile)

vertex pharmaceuticals (chile) s.p.a. - elexacaftor; ivacaftor; tezacaftor - elexacaftor 50,00 mg núcleo del comprimido recubierto naranja; ivacaftor 46,88 mg núcleo del comprimido recubierto naranja; ivacaftor 93,75 mg núcleo del comprimido recubierto celeste; tezacaftor 31,25 mg núcleo del comprimido recubierto naranja - indicado para el tratamiento de la fibrosis quística (fq) en pacientes mayores de 6 años que tienen al menos una mutación f508del en el gen regulador de la conductancia transmembrana de la fibrosis quística (cftr) o una mutación en el gen cftr que sea susceptible a responder, según datos in vitro.

Unión Europea - español - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - fibrosis quística - otros productos del sistema respiratorio - 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.

Unión Europea - español - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibrosis quística - otros productos del sistema respiratorio - orkambi comprimidos está indicado para el tratamiento de la fibrosis quística (fq) en pacientes mayores de 6 años y más que son homocigotos para la mutación f508del en el gen 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.

Ecuador - español - Agencia Nacional de Regulación, Control y Vigilancia Sanitaria

gador s.a. argentina - ivacaftor 125 mg lumacaftor 200 mg - comprimido recubierto - cada comprimido recubierto contiene: ivacaftor 125 mg lumacaftor 200 mg

Uruguay - español - Ministerio de Salud (Dirección Oficina Central)

scienza uruguay - comprimido - elexacaftor 100 mg + tezacaftor 50 mg + ivacaftor 75 mg comprimido e ivacaftor 150 mg comprimido

Uruguay - español - Ministerio de Salud (Dirección Oficina Central)

scienza uruguay - comprimido - elexacaftor 50 mg + tezacaftor 25 mg + ivacaftor 37,5 mg comprimido e ivacaftor 75 mg comprimido

Ecuador - español - Agencia Nacional de Regulación, Control y Vigilancia Sanitaria

monte verde sa. argentina - lumacaftor 100,0000 mg ivacaftor 125,0000 mg - comprimidos recubiertos - cada comprimido recubierto contiene: lumacaftor 100,0000 mg (a) ivacaftor 125,0000 mg (a)