Canada - English - Health Canada

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

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; 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.

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - ivacaftor 150mg;  ;  ; tezacaftor 100mg;  ;  ; ivacaftor 150mg - film coated tablet - active: ivacaftor 150mg     tezacaftor 100mg     excipient: croscarmellose sodium hypromellose hypromellose acetate succinate magnesium stearate microcrystalline cellulose opadry yellow 20a120010 sodium laurilsulfate active: ivacaftor 150mg excipient: carnauba wax colloidal silicon dioxide croscarmellose sodium hypromellose acetate succinate lactose monohydrate magnesium stearate microcrystalline cellulose opacode black s-1-17823 opadry blue 85f90614 sodium laurilsulfate - symdeko is 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.