Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi b.v. - eliglustat - gauchersjúkdómur - Önnur meltingarvegi og efnaskipti vörur, - cerdelga er ætlað til lengri tíma meðferð fullorðinn sjúklinga með eins sjúkdómur tegund 1 (gd1), sem eru cyp2d6 léleg metabolisers (fyrirtíðaspennu), millistig metabolisers (skilaboð) eða mikla metabolisers (sjúkrabíl).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - kólesterólhækkun - lipid breytandi lyf - hvert er ætlað sem viðbót til að lágt‑feitur mataræði og öðrum fitu‑lækka lyf með eða án lágt-þéttleiki-lípóprótein (gegn) apheresis í fullorðinn sjúklinga með tilbúin ættingja hypercholesterolaemia (hofh). erfðafræðilega staðfestingu á hofh ætti að vera fæst þegar það er mögulegt. annars konar aðal hyperlipoproteinaemia og efri veldur hypercholesterolaemia (e. nýrungaheilkenni, of) verður að vera útilokað.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - sucroferric oxyhydroxide - hyperphosphatemia; renal dialysis - lyf til meðferð kalíum og blóðfosfathækkun - velphoro er ætlað til að stjórna fosfórmagn í sermi hjá sjúklingum með langvarandi nýrnabilun hjá fullorðnum sjúklingum með blóðskilun (hd) eða kviðskilun (pd). velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with ckd stages 4-5 (defined by a glomerular filtration rate.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astma - lyf til veikindi öndunarvegi sjúkdómum, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - ofsabjúgur, arfgengur - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - Öll önnur lækningavörur - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - tedizólíð fosfat - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, , other antibacterials - sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and adolescents 12 years of age and older.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pharmathen s.a. - memantínhýdróklóríð - alzheimer sjúkdómur - psychoanaleptics, , Önnur anti-heilabilun lyf - meðferð sjúklinga með miðlungsmikla til alvarlega alzheimerssjúkdóma.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - Ónæmisbælandi lyf - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriasis arthritiscosentyx, einn eða ásamt stendur (metÓtrexati), er ætlað fyrir meðferð virk psoriasis liðagigt í fullorðinn sjúklinga þegar svar til fyrri sjúkdómur breyta gegn gigt eiturlyf (dmard) meðferð hefur verið ófullnægjandi. axial spondyloarthritis (axspa)hryggikt (eins og, röntgen axial spondyloarthritis)cosentyx er ætlað fyrir meðferð virk hryggikt í fullorðnir sem hafa brugðist ekki nægilega til að hefðbundin meðferð. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.