Israel - hebraico - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - טבליות מצופות פילם - ivacaftor 150 mg - ivacaftor

Israel - hebraico - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - גרנולות - ivacaftor 50 mg - ivacaftor

Israel - hebraico - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - גרנולות - ivacaftor 75 mg - ivacaftor

Israel - inglês - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; tezacaftor - film coated tablets - ivacaftor 150 mg; tezacaftor 100 mg - ivacaftor and tezacaftor - symdeko is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (cf) aged 12 years and older who are homozygous for the f508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.if the patient’s genotype is unknown, a health authority cleared cf mutation test should be used to detect the presence of a cftr mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

Israel - inglês - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; tezacaftor - film coated tablets - ivacaftor 150 mg; tezacaftor 100 mg - ivacaftor and tezacaftor - symdeko is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (cf) aged 12 years and older who are homozygous for the f508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.if the patient’s genotype is unknown, a health authority cleared cf mutation test should be used to detect the presence of a cftr mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

União Europeia - húngaro - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cisztás fibrózis - egyéb légzőszervi termékek - orkambi tabletta javallott a cisztás fibrózis (cf) a betegek éves 6 éves vagy idősebb, akik homozigóta a f508del mutáció a cftr gén. 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.

União Europeia - eslovaco - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystická fibróza - ostatné produkty dýchacej sústavy - 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 a 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 a 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 - eslovaco - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystická fibróza - ostatné produkty dýchacej sústavy - 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.

União Europeia - eslovaco - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystická fibróza - ostatné produkty dýchacej sústavy - orkambi tablety sú uvedené pre liečbu cystickej fibrózy (cf) u pacientov vo veku 6 rokov a starších, ktorí sú homozygous pre f508del mutácie v cftr géne. 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.

União Europeia - esloveno - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistična fibroza - drugi proizvodi dihal - orkambi tablete so primerna za zdravljenje cistična fibroza (cf) pri bolnikih, starih 6 let in več, ki so homozygous za f508del mutacije v cftr gena. 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.