Evrópusambandið - íslenska - EMA (European Medicines Agency)

amgen europe bv - apremilast - arthritis, psoriatic; psoriasis - Ónæmisbælandi lyf - psoriasis arthritisotezla, einn eða í bland með sjúkdóm breyta verkjalyf lyf (sjúkdómstemprandi), er ætlað fyrir meðferð virk psoriasis liðagigt (meina) í fullorðinn sjúklingar sem hafa verið ófullnægjandi svar eða sem hafa verið með óþol fyrir áður dmard meðferð. psoriasisotezla er ætlað fyrir meðferð í meðallagi til alvarlega langvarandi sýklum psoriasis í fullorðinn sjúklingum sem tókst ekki að svara eða sem hafa frábending, eða þola öðrum almenna meðferð þar á meðal cíklósporín stendur eða psoralen og útfjólubláum-ljós (puva).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - liðagigt, liðagigt - Ónæmisbælandi lyf - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant má nota sem einlyfjameðferð eða í samsettri meðferð með metotrexati. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - risankizumab - psoriasis; arthritis, psoriatic - Ónæmisbælandi lyf - plaque psoriasisskyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisskyrizi, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). crohn's diseaseskyrizi is indicated for the treatment of adult patients with moderately to severely active crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

eli lilly nederland b.v. - mirikizumab - ristilbólga, þvagsýrugigt - Ónæmisbælandi lyf - omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - ceftolozane súlfat, tazobactam járn - bakteríusýkingar - sýklalyf fyrir almenn nota, - zerbaxa is indicated for the treatment of the following infections in adults:complicated intra abdominal infections;acute pyelonephritis;complicated urinary tract infections;hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap). Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - liðagigt, liðagigt - Ónæmisbælandi lyf - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

alexion europe sas - eculizumab - blóðrauði, ofsakláði - Ónæmisbælandi lyf - soliris er ætlað í fullorðna og börn fyrir meðferð:paroxysmal nóttu haemoglobinuria (pnh). sönnunargögn klínískum gagn er sýnt í sjúklinga með haemolysis með klínískum einkenni(s) marks um hár sjúkdómur starfsemi, óháð blóðgjöf sögu (sjá kafla 5. Óhefðbundin blóðlýsu uremic (ahus). soliris er ætlað í fullorðnir fyrir meðferð:svarar almenn vöðvaslensfár (gmg) í sjúklingum sem eru anti-asetýlkólíns viðtaka (achr) mótefni-jákvæð (sjá kafla 5. neuromyelitis optica svið röskun (nmosd) í sjúklingum sem eru anti-aquaporin-4 (aqp4) mótefni-jákvæð við köstum auðvitað sjúkdómsins.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabín - forliða t-frumu eitilfrumuhvítblæði í eitilfrumuæxli - Æxlishemjandi lyf - nelarabine er ætlað fyrir sjúklinga með t-klefi bráðu eitilfrumuhvítblæði hvítblæði (t-allir) og t-klefi eitilfrumuhvítblæði eitlaæxli (t-lbl) sem sjúkdómurinn hefur ekki svarað til eða hefur fallið eftir meðferð með að minnsta kosti tvær lyfjameðferð meðferð. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bayer animal health gmbh - iron(iii) ion, toltrazuril - toltrazuril, sturtu - svín (smágrísir) - fyrir samhliða fyrirbyggja klínískum merki um hníslasótt (eins og niðurgangur) í nýbura grísi á býli með staðfest sögu hníslasótt af völdum cystoisospora am, og koma í veg fyrir járn skort blóðleysi.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ceva-phylaxia veterinary biologicals co. ltd - turkey herpes virus, strain rhvt/nd/ibd, expressing the fusion protein of newcastle disease virus and the vp2 protein of infectious bursal disease virus, live recombinant - Ónæmissjúkdómar fyrir fugla - embryonated chicken eggs; chicken - for the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by newcastle disease virus (ndv) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (ibdv); to reduce mortality, clinical signs and lesions caused by classical marek’s disease virus (mdv).