Canada - English - Health Canada

vertex pharmaceuticals (canada) incorporated - ivacaftor; lumacaftor - tablet - 125mg; 200mg - ivacaftor 125mg; lumacaftor 200mg - cystic fibrosis transmembrane conductance regulator correctors

Canada - English - Health Canada

vertex pharmaceuticals (canada) incorporated - ivacaftor; lumacaftor - tablet - 125mg; 100mg - ivacaftor 125mg; lumacaftor 100mg - cystic fibrosis transmembrane conductance regulator correctors

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

vertex pharmaceuticals (uk - ivacaftor; lumacaftor - tablet - 125mg ; 200mg

Canada - English - Health Canada

vertex pharmaceuticals (canada) incorporated - lumacaftor; ivacaftor - granules - 100mg; 125mg - lumacaftor 100mg; ivacaftor 125mg - cystic fibrosis transmembrane conductance regulator correctors

Canada - English - Health Canada

vertex pharmaceuticals (canada) incorporated - lumacaftor; ivacaftor - granules - 150mg; 188mg - lumacaftor 150mg; ivacaftor 188mg - cystic fibrosis transmembrane conductance regulator correctors

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 100 mg - ivacaftor and lumacaftor - orkambi is 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 limitations of use the efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - ivacaftor; lumacaftor - film coated tablets - ivacaftor 125 mg; lumacaftor 100 mg - ivacaftor and lumacaftor - orkambi is 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 limitations of use the efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation

Israel - English - 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 - English - 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 - English - 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.