Israel - English - 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 - English - 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.

United States - English - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - tezacaftor (unii: 8rw88y506k) (tezacaftor - unii:8rw88y506k), ivacaftor (unii: 1y740ill1z) (ivacaftor - unii:1y740ill1z) - tezacaftor 100 mg - symdeko is indicated for the treatment of cystic fibrosis (cf) in patients age 6 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 [see clinical pharmacology (12.1) and clinical studies (14)] . if the patient's genotype is unknown, an fda-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. none. risk summary there are limited and incomplete human data from clinical trials and postmarketing reports on the use of symdeko or its individual components, tezacaftor and ivacaftor, in pregnant women to inform a drug-associated risk. although there are no animal reproduction studies with the concomitant administration of tezacaftor and ivacaftor, separate reproductive

European Union - English - 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.

European Union - English - 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.

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; ivacaftor; tezacaftor - film coated tablets - ivacaftor 75 mg; tezacaftor 50 mg; ivacaftor 75 mg - ivacaftor and tezacaftor - symdeko is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (cf) age 6 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 - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - elexacaftor; ivacaftor; ivacaftor; tezacaftor - film coated tablets - ivacaftor 75 mg; tezacaftor 50 mg; elexacaftor 100 mg; ivacaftor 150 mg - ivacaftor, tezacaftor and elexacaftor - trikafta is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data.

Australia - English - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 75 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; lactose monohydrate; silicon dioxide; magnesium stearate; carnauba wax; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - trikafta is indicated 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.

Canada - English - Health Canada

vertex pharmaceuticals (canada) incorporated - tezacaftor; ivacaftor; ivacaftor; elexacaftor - tablet - 50mg; 75mg; 150mg; 100mg - tezacaftor 50mg; ivacaftor 75mg; ivacaftor 150mg; elexacaftor 100mg - cystic fibrosis transmembrane conductance regulator correctors

European Union - English - 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.