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

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 125 mg; lumacaftor, quantity: 200 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified water; purified talc; brilliant blue fcf aluminium lake; polyvinyl alcohol; macrogol 3350; cochineal; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

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

vertex pharmaceuticals australia pty ltd - lumacaftor, quantity: 75 mg; ivacaftor, quantity: 94 mg - granules - excipient ingredients: croscarmellose sodium; hypromellose acetate succinate; microcrystalline cellulose; povidone; sodium lauryl sulfate - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

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

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 125 mg; lumacaftor, quantity: 100 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified water; purified talc; brilliant blue fcf aluminium lake; polyvinyl alcohol; macrogol 3350; cochineal; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

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

vertex pharmaceuticals australia pty ltd - lumacaftor, quantity: 150 mg; ivacaftor, quantity: 188 mg - granules - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; sodium lauryl sulfate; hypromellose acetate succinate - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

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

vertex pharmaceuticals australia pty ltd - lumacaftor, quantity: 100 mg; ivacaftor, quantity: 125 mg - granules - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; sodium lauryl sulfate; hypromellose acetate succinate - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

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

vertex pharmaceuticals incorporated - lumacaftor (unii: egp8l81apk) (lumacaftor - unii:egp8l81apk), ivacaftor (unii: 1y740ill1z) (ivacaftor - unii:1y740ill1z) - lumacaftor 200 mg - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene. if the patient's genotype is unknown, an fda-cleared cf mutation test should be used to detect the presence of the f508del mutation on both alleles of 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. none. risk summary there are limited and incomplete human data from clinical trials and postmarketing reports on use of orkambi or its individual components, lumacaftor or ivacaftor, in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of lumacaftor to pregnant rats and rabbits during organogenesis demonstrated no teratogenicity or adverse effects on fetal development at doses that produced maternal exposures up to approximately 8 (rats) and 5 (rabbits) times the exposure at the maxim

European Union - English - 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.

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.