Unia Europejska - angielski - 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.

Unia Europejska - angielski - EMA (European Medicines Agency)

krka, d.d., novo mesto - telmisartan, hydrochlorothiazide - hypertension - telmisartan and diuretics - tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Kanada - angielski - Health Canada

merck canada inc - hepatitis b surface antigen (recombinant) - suspension - 10mcg - hepatitis b surface antigen (recombinant) 10mcg - vaccines

Kanada - angielski - Health Canada

merck canada inc - hepatitis b surface antigen (recombinant) - suspension - 40mcg - hepatitis b surface antigen (recombinant) 40mcg - vaccines

Stany Zjednoczone - angielski - 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

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

merck sharp & dohme llc - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 5 ug in 0.5 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. there are no adequate and well-controlled studies designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - xembify® (immune globulin subcutaneous, human – klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of primary humoral immunodeficiency (pi) in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.[1-4] xembify is contraindicated in: patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. iga deficient patients with antibodies against iga and history of hypersensitivity to human immune globulin treatment. risk summary no human data are available to indicate the presence or absence of drug associated risk. animal reproduction studies have not been conducted with xembify. it is not known whether xembify can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immune globulins cross the placenta from m

Malezja - angielski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pusat darah negara - factor ix fraction,dried; factor x/stuart factor; factor ii/prothrombin -

Izrael - angielski - 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

Izrael - angielski - 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