Evrópusambandið - íslenska - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - bempedoic sýru, ezetimibe - hypercholesterolemia; dyslipidemias - lipid breytandi lyf - nustendi er ætlað í fullorðnir með aðal hypercholesterolaemia (ný ættingja og ekki ættingja) eða blandað dyslipidaemia, sem viðbót til að mataræði:ásamt statín í sjúklingar ófær um að ná gegn-c markmið með hámarks þolað skammt af cholestagel í viðbót til að ezetimibealone í sjúklingum sem eru annaðhvort statín-óþol eða fyrir hvern cholestagel er ætlað, og ert ófær um að ná í gegn-c markmið með ezetimibe einn,í sjúklinga þegar í meðferð með blöndu af bempedoic sýru og ezetimibe eins og að aðskilja töflur með eða án statín.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

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

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Æxlishemjandi lyf - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - veirueyðandi lyf til almennrar notkunar - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

nabriva therapeutics ireland dac - lefamulin acetate - pneumonia, bacterial; community-acquired infections - sýklalyf fyrir almenn nota, - xenleta is indicated for the treatment of community-acquired pneumonia (cap) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of cap or when these have failed. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - sýklalyf - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinal stromal tumors - Æxlishemjandi lyf - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amgen europe bv - sotorasib - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.