Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - 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 i 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 i 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabine - lymphoblastic leukemija-limfom t-stanica prekursora - antineoplastična sredstva - nelarabine indiciran za liječenje bolesnika sa t-клеточным oštrim лимфобластным лейкозом (t-all) i t-stanični limfocitne limfom (t-ЛБЛ), čija bolest ne odgovara, ili je nastao recidiva nakon tretmana s najmanje dva načina kemoterapije. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Europska Unija - hrvatski - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - brexpiprazole - shizofrenija - psycholeptics - liječenje shizofrenije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskularna blokada - svi ostali terapeutski proizvodi - uklanjanje neuromuskularne blokade izazvane rokoronom ili vekuronomom. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Europska Unija - hrvatski - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - Толваптан - policistični bubreg, autosomno dominantan - diuretici, - jinarc je naznačeno da se usporiti napredovanje cista razvoj i bubrežnom insuficijencijom autosomno dominantnom policističnom bolešću bubrega (adpkd) u odraslih osoba s ckd pozornica 1 do 3 na početak liječenja s dokazima o brzo napreduje bolest.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - tablete orkambi rezultati za liječenje муковисцидоза (mv) kod bolesnika u dobi od 6 i više godina, koji su гомозиготами na mutacije f508del u genu cftr . 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - Толваптан - neprimjereni adh sindrom - diuretici, - liječenje odraslih bolesnika s hiponatrijemom sekundarnim sindromom neodgovarajućeg izlučivanja antidiuretičko-hormonskog hormona (siadh).

Europska Unija - hrvatski - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - imunosupresivi - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Europska Unija - hrvatski - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.