Europska Unija - hrvatski - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatonin - poremećaji uvođenja i održavanja spavanja - psycholeptics - circadin je indiciran kao monoterapija za kratkotrajno liječenje primarne nesanice karakterizirane lošom kvalitetom sna u bolesnika starijih od 55 godina.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mukopolisaharidoza ii - drugi gastrointestinalni trakt i metabolizam, lijekovi, - elaprase je indiciran za dugotrajno liječenje bolesnika sa hunter sindrom (mukopolisaharidozom ii, gpp ii). heterozigotne ženke nisu proučavane u kliničkim ispitivanjima.

Europska Unija - hrvatski - EMA (European Medicines Agency)

laboratoire hra pharma - ulipristal - kontracepcija, postcoital - spolni hormoni i modulatori genitalnog sustava , sredstva za hitne kontracepcije - hitna kontracepcija unutar 120 sati (pet dana) nezaštićenog seksualnog odnosa ili neuspjeha kontracepcije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare bv - lamivudin - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - epivir je indiciran kao dio antiretrovirusne kombinirane terapije za liječenje odraslih osoba i djece s virusom humane imunodeficijencije (hiv).

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharmaceuticals international ag - ikatiban - angioedemas, nasljedni - srčana terapija - firazyr je indiciran za simptomatsko liječenje akutnog napada nasljednog angioedema (hae) u odraslih osoba (sa c1 esteraze nedostatak).

Europska Unija - hrvatski - EMA (European Medicines Agency)

vanda pharmaceuticals netherlands b.v. - tasimelteon - poremećaji spavanja, cirkadijski ritam - psycholeptics - hetlioz je indiciran za liječenje ne-24-satnog poremećaja spavanja (ne-24) u potpuno slijepim odraslima.

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)

takeda pharmaceuticals international ag ireland branch - agalsidaza alfa - fabry-ovu bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - replagal je indiciran za dugotrajnu terapiju zamjene enzima u bolesnika s potvrđenom dijagnozom fabryove bolesti (nedostatak α-galaktozidaze-a).

Europska Unija - hrvatski - EMA (European Medicines Agency)

les laboratoires servier - irinotecan anhydrous free-base - neoplazme gušterače - antineoplastična sredstva - liječenje metastatskog adenokarcinoma gušterače, u kombinaciji s 5 fluorouracil (5 fu) i leucovorin (lv), u odraslih bolesnika napredovala nakon gemcitabinom osnovu terapije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrheal sredstva, uzročnika crijevnih protuupalnih / antiinfective - truberzi je indiciran kod odraslih osoba za liječenje sindroma iritabilnog crijeva s proljevom (ibs d).