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

recordati ireland ltd - silodosin - prostatisk hyperplasi - urologika - behandling av tegn og symptomer på godartet prostatahyperplasi (bph).

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.

Norge - norsk - Statens legemiddelverk

newbury pharmaceuticals ab - ikatibantacetat - injeksjonsvæske, oppløsning i ferdigfylt sprøyte - 30 mg

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

crealta pharmaceuticals ireland limited - pegloticase - gikt - antigout preparater - krystexxa er indisert for behandling av alvorlig ødeleggende kroniske tophaceous gikt hos voksne pasienter som har også erosive felles engasjement og som har mislyktes i å normalisere serum urinsyre med xantin oksidase hemmere nådd medisinsk passende dose eller som disse legemidlene er kontraindisert.

Norge - norsk - Statens legemiddelverk

aop orphan pharmaceuticals gmbh - tadalafil - tablett, filmdrasjert - 20 mg

Norge - norsk - Statens legemiddelverk

newbury pharmaceuticals ab - solifenacinsuksinat / tamsulosinhydroklorid - tablett med modifisert frisetting - 6 mg / 0.4 mg

Norge - norsk - Statens legemiddelverk

amdipharm ltd - terazosinhydrokloriddihydrat - tablett - 1 mg / 2 mg

Norge - norsk - Statens legemiddelverk

amdipharm ltd - terazosinhydrokloriddihydrat - tablett - 2 mg

Norge - norsk - Statens legemiddelverk

amdipharm ltd - terazosinhydrokloriddihydrat - tablett - 5 mg

Norge - norsk - Statens legemiddelverk

amdipharm ltd - terazosinhydrokloriddihydrat - tablett - 10 mg