Den europeiske union - maltesisk - EMA (European Medicines Agency)

samsung bioepis nl b.v. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; hidradenitis suppurativa; arthritis - immunosoppressanti - rewmatika arthritisimraldi flimkien ma ' methotrexate, huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatika attiva f'pazjenti adulti, meta r-rispons li jimmodifikaw il-marda anti-rewmatiċi-mediċini inkluż methotrexate, ma jkunx adegwat. il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'methotrexate. imraldi jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritisimraldi in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. enthesitis-related arthritisimraldi is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)imraldi is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of asimraldi is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). psorjatika arthritisimraldi huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika fl-adulti meta r-rispons għall-preċedenti li jimmodifikaw il-marda anti-rewmatiċi terapija bil-mediċina kienet inadegwata. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5. 1) u li jtejjeb il-funzjoni fiżika. psoriasisimraldi huwa indikat għall-kura moderata għal severa ta ' psorjasi tal-plakka kronika f'pazjenti adulti li huma kandidati għat-terapija sistemika. pedjatrika tal-plakka psoriasisimraldi huwa indikat għall-kura ta kroniku sever tal-psorjasi tal-plakka fit-tfal u fl-adolexxenti mill-età ta ' 4 snin li kellhom rispons inadegwat għal, jew huma xierqa għall-kandidati għal terapija topika u fototerapiji. hidradenitis suppurativa (hs)imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 u 5. crohn diseaseimraldi huwa indikat għall-kura ta attiva minn moderata sa gravi marda ta ' crohn, f'pazjenti adulti li ma kellhomx rispons minkejja sħiħ u adegwat matul it-terapija b'xi corticosteroid u/jew immunosoppressanti; jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. paediatric crohn's diseaseimraldi is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or haveulcerative colitisimraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitisimraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitisimraldi is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate. paediatric uveitisimraldi is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

novartis europharm limited - omalizumab - asthma; urticaria - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - allerġiċi asthmaxolair huwa indikat fl-adulti, l-adoloxxenti u t-tfal (6 sa.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

serono europe limited - efalizumab - psorajiżi - immunosoppressanti - trattament tal-pazjenti adulti ma moderat biex psoriasis plakka kronika severi li jkunu naqqsu milli jwieġbu għal, jew li jkollhom a contraindication li, jew li huma intolerant li t-terapiji sistematiċi oħra inklużi ciclosporin, methotrexate u puva (ara taqsima 5. 1 - effikaċja klinika).

Den europeiske union - maltesisk - EMA (European Medicines Agency)

theratechnologies europe limited - ibalizumab - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - trogarzo, flimkien ma 'antiretrovirali oħra(i), huwa indikat għall-kura ta' adulti infettati bil għal ħafna mediċini hiv-1 reżistenti għal infezzjoni li għalihom huwa inkella mhux possibbli li jinbena soppressiva antivirali reġimen.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 u 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - sklerosi multipla - immunosuppressanti selettivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 u 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għad-dokument ta 'informazzjoni dwar il-prodott.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għas-sezzjoni 4. 1 tas-sommarju tal-karatteristiċi tal-prodott fid-dokument ta 'informazzjoni tal-prodott.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

abbott laboratories ltd. - adalimumab - spondylitis, ankylosing; arthritis, rheumatoid; arthritis, psoriatic; crohn disease - immunosoppressanti - rewmatika arthritistrudexa flimkien ma ' methotrexate, huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatika attiva f'pazjenti adulti, meta r-rispons li jimmodifikaw il-marda anti-rewmatiċi-mediċini inkluż methotrexate, ma jkunx adegwat. il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'methotrexate. trudexa jista 'jingħata waħdu f'każ ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. intwera li trudexa jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. psorjatika arthritistrudexa huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika fl-adulti meta r-rispons għall-preċedenti li jimmodifikaw il-marda anti-rewmatiċi terapija bil-mediċina kienet inadegwata. ankylosing spondylitistrudexa huwa indikat għall-kura ta ' adulti li jbatu minn ankylosing spondylitis attiva li kellhom rispons mhux adekwat għat-terapija. crohn diseasetrudexa huwa indikat għall-kura ta ' marda ta'crohn attiva, f'pazjenti li ma kellhomx rispons minkejja sħiħ u adegwat matul it-terapija b'xi corticosteroid u/jew immunosoppressanti; jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. għall-kura tal-bidu, trudexa għandu jingħata flimkien ma ' corticosteroids. trudexa jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għall-corticosteroids jew meta titkompla l-kura bil-corticosteroids m'hijiex adattata (ara sezzjoni 4.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - immunosoppressanti - jekk jogħġbok irreferi għas-sezzjoni 4. 1 tas-sommarju tal-karatteristiċi tal-prodott fid-dokument ta 'informazzjoni tal-prodott.