Unjoni Ewropea - Iżlandiż - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatónín - svefntruflun og viðhald - psycholeptics - melatonin neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.

Islanda - Iżlandiż - LYFJASTOFNUN (Icelandic Medicines Agency)

teva b.v.* - melatoninum inn - forðatafla - 2 mg

Islanda - Iżlandiż - LYFJASTOFNUN (Icelandic Medicines Agency)

actavis group ptc ehf. - clopidogrelum súlfat - filmuhúðuð tafla - 75 mg

Islanda - Iżlandiż - LYFJASTOFNUN (Icelandic Medicines Agency)

medical valley invest ab - travoprostinum inn; timololum maleat - augndropar, lausn - 40 míkróg/ml + 5 mg/ml

Islanda - Iżlandiż - LYFJASTOFNUN (Icelandic Medicines Agency)

oresund pharma aps - omeprazolum inn - mixtúruduft, dreifa - 2 mg/ml

Islanda - Iżlandiż - LYFJASTOFNUN (Icelandic Medicines Agency)

medical valley invest ab - clopidogrelum besýlat - filmuhúðuð tafla - 75 mg

Unjoni Ewropea - Iżlandiż - EMA (European Medicines Agency)

basilea pharmaceutica deutschland gmbh - isavuconazol - aspergillosis - cresemba er ætlað í fullorðnir fyrir meðferð:innrásar aspergillosismucormycosis í sjúklingar sem amfótericín b er inappropriateconsideration ætti að opinbera leiðsögn á réttri notkun mikla lyfjum.

Unjoni Ewropea - Iżlandiż - EMA (European Medicines Agency)

amicus therapeutics europe limited - migalastat hydrochloride - fabry sjúkdómur - migalastat - galafold er ætlað til langvarandi meðferðar hjá fullorðnum og unglingum 16 ára og eldri með staðfestri greiningu á fabry-sjúkdómum (α-galaktósíðasa a skort) og sem hefur örugg stökkbreytingu.

Unjoni Ewropea - Iżlandiż - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - polycystic nýru, autosomal dominant - Þvagræsilyf, - jinarc er ætlað að hægja á framvindu blaðra þróun og nýrnabilun litnings ríkjandi einn nýrnasjúkdóm (adpkd) í fullorðnir með langvinnan stigi 1 til 3 á upphaf meðferð með sönnunargögn hratt gengur sjúkdómur.

Unjoni Ewropea - Iżlandiż - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystic fibrosis - Önnur öndunarfæri - 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.