Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 200 mg - ivacaftor and lumacaftor - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who are homozygous for the f508del mutation in the cftr gene.if the patient's genotype is unknown, cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene.limitations of usethe efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation.

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - granules - ivacaftor 50 mg - ivacaftor - kalydeco granules are indicated for the treatment of children with cystic fibrosis (cf) aged 2 years and older and weighing less than 25 kg who have one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r. limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene.

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - granules - ivacaftor 75 mg - ivacaftor - kalydeco granules are indicated for the treatment of children with cystic fibrosis (cf) aged 2 years and older and weighing less than 25 kg who have one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r. limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene.

Den europeiske union - engelsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystic fibrosis - other respiratory system products - 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 and 5.1).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 5.1).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 and 5.1).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.

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - film coated tablets - ivacaftor 150 mg - ivacaftor - kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (cf) aged 6 years and older and weighing 25 kg or more who have one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r.limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - film coated tablets - ivacaftor 150 mg - ivacaftor - kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (cf) aged 6 years and older and weighing 25 kg or more who have one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r.limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene

Israel - engelsk - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor - film coated tablets - ivacaftor 150 mg - ivacaftor - kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (cf) aged 6 years and older and weighing 25 kg or more who have one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r.limitations of use:kalydeco is not effective in patients with cf who are homozygous for the f508del mutation in the cftr gene

Den europeiske union - engelsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystic fibrosis - other respiratory system products - orkambi tablets are indicated for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who are homozygous for the f508del mutation in the cftr gene.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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystic fibrosis - other respiratory system products - 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.

Den europeiske union - engelsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystic fibrosis - other respiratory system products - 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.