Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystisk fibrose - andre åndedrettsprodukter - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 og 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the 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. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 og 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystisk fibrose - andre åndedrettsprodukter - orkambi tabletter er angitt for behandling av cystisk fibrose (cf) hos pasienter i alderen 6 år og eldre som er homozygote for f508del-mutasjon i cftr-genet. 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.

Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystisk fibrose - andre åndedrettsprodukter - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystisk fibrose - andre åndedrettsprodukter - 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.

Norge - norsk - Statens legemiddelverk

2care4 generics aps - finasterid - tablett, filmdrasjert - 1 mg

Den europeiske union - norsk - EMA (European Medicines Agency)

curium pet france - piflufolastat (18f) - prostata neoplasmer - diagnostiske radiopharmaceuticals - dette legemidlet er kun til diagnostisk bruk. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Den europeiske union - norsk - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabin - forløper t-celle lymfoblastisk leukemi-lymfom - antineoplastiske midler - nelarabine er indisert for behandling av pasienter med t-celle akutt lymfoblastisk leukemi (t-all) og t-celle lymfoblastisk lymfom (t-lbl) hvis sykdommen ikke har svart eller har tilbakefall etter behandling med minst to kjemoterapi regimer. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Den europeiske union - norsk - EMA (European Medicines Agency)

advanz pharma limited - obeticholic syre - levercirrhose, galli - galle- og leverterapi - ocaliva er indisert for behandling av primære biliær kolangitt (også kjent som primær biliary skrumplever) i kombinasjon med ursodeoxycholic syre (udca) i voksne med en utilstrekkelig svar til udca eller som monoterapi i voksne kan ikke tolerere udca.

Den europeiske union - norsk - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - human fibrinogen, human trombin - hemostase - lokale hemostatics - støttende behandling i voksenoperasjon der standard kirurgiske teknikker er utilstrekkelige (se avsnitt 5. 1):- for forbedring av haemostasis.

Den europeiske union - norsk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hypertensjon - agenter som virker på renin-angiotensinsystemet - behandling av essensiell hypertensjon. amlodipine/valsartan mylan er indisert hos voksne hvis blodtrykket ikke er tilstrekkelig kontrollert på amlodipine eller valsartan monoterapi.