Ngenla Den Europæiske Union - islandsk - EMA (European Medicines Agency)

ngenla

pfizer europe ma eeig - somatrogon - growth and development - sterum og undirstÚku hormÓn og hliÐstÆÐum - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.

Riltrava Aerosphere Den Europæiske Union - islandsk - EMA (European Medicines Agency)

riltrava aerosphere

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - lungnasjúkdómur, langvarandi hindrandi - lyf til veikindi öndunarvegi sjúkdómum, - riltrava aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.

Opdualag Den Europæiske Union - islandsk - EMA (European Medicines Agency)

opdualag

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Descovy Den Europæiske Union - islandsk - EMA (European Medicines Agency)

descovy

gilead sciences ireland uc - meðferð með eviplera nýrnastarfsemi alafenamide - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv-1).

Jakavi Den Europæiske Union - islandsk - EMA (European Medicines Agency)

jakavi

novartis europharm limited - ruxolitinib (sem fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - Æxlishemjandi lyf - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (Úsbekistan)ráðlagt er ætlað fyrir meðferð fullorðinn sjúklinga með polycythaemia vera sem eru ónæmir fyrir eða þola hýdroxýúrea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Kalydeco Den Europæiske Union - islandsk - EMA (European Medicines Agency)

kalydeco

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.

Vipdomet Den Europæiske Union - islandsk - EMA (European Medicines Agency)

vipdomet

takeda pharma a/s - rannsóknir á dýra, kvarta stutt og long-term - sykursýki, tegund 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;in combination with pioglitazone (i. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;in combination with insulin (i. þrefaldur samsetning meðferð) sem viðbót til að fæði og æfa til að bæta blóðsykursstjórnun í sjúklinga þegar insúlín í stöðugu skammtur og kvarta einn veita ekki fullnægjandi blóðsykursstjórnun.

Xtandi Den Europæiske Union - islandsk - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamíð - blöðruhálskirtli - innkirtla meðferð - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Symkevi Den Europæiske Union - islandsk - EMA (European Medicines Agency)

symkevi

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystic fibrosis - Önnur öndunarfæri - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (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.

Retsevmo Den Europæiske Union - islandsk - EMA (European Medicines Agency)

retsevmo

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - Æxlishemjandi lyf - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.