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

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

emceta international, inc - maca - maca....500.00 mg.

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.

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.