Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - valdar ónæmisbælandi lyf - sárum colitisentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka sárum niðurgang sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. crohn-diseaseentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka crohn-sjúkdóm sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - Ónæmisbælandi lyf - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - deucravacitinib - psoriasis - Ónæmisbælandi lyf - treatment of moderate-to-severe plaque psoriasis in adults.

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)

argenx - efgartigimod alfa - myasthenia gravis - Ónæmisbælandi lyf - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi b.v. - sutimlimab - hemolysis; anemia, hemolytic, autoimmune - Ónæmisbælandi lyf - enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (cad).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - margvísleg sclerosis - valdar ónæmisbælandi lyf - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi belgium - alemtuzumab - margvísleg sclerosis - valdar ónæmisbælandi lyf - lemtrada er ætlað fullorðnum sjúklingum með endurtekna endurtekna mænusigg (rrms) með virkum sjúkdómum sem eru skilgreindar með klínískum eða hugsanlegum eiginleikum.

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)

pfizer europe ma eeig - tofacitinib - liðagigt, liðagigt - Ónæmisbælandi lyf - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 og 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.