Unjoni Ewropea - Malti - EMA (European Medicines Agency)

lipomed gmbh - cladribine - leukemia, hairy taċ-ċelloli - aġenti antineoplastiċi - litak huwa indikat għat-trattament tal-lewkimja taċ-ċelluli tax-xagħar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ritonavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - ritonavir huwa indikat flimkien ma 'aġenti antiretrovirali oħra għall-kura ta' pazjenti infettati bl-hiv-1 (adulti u tfal ta 'sentejn u akbar).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - bosentan (as monohydrate) - hypertension, pulmonary; scleroderma, systemic - prodotti oħrajn għal pressjoni għolja - trattament ta 'pressjoni għolja arterjali pulmonari (pah) biex tittejjeb il-kapaċità ta' eżerċizzju u s-sintomi f'pazjenti bl-organizzazzjoni dinjija tas-saħħa (who) klassi funzjonali iii. l-effikaċja ntweriet fi:primarja (idjopatika u familjali) u pah;pah sekondarja għal skleroderma mingħajr mard pulmonari interstizjali sinifikanti;pah marbuta ma'shunts sistemiċi-pulmonari konġenitali u eisenmenger tal-fiżjoloġija. xi titjib intwera wkoll f'pazjenti b'pah klassi funzjonali who ii. stayveer huwa ndikat ukoll biex inaqqas in-numru ta 'ulċeri ġodda fis-swaba f'pazjenti bi sklerosi sistemika u l-għaddejjin diġitali 'mard ta' ulċera.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - għal pressjoni għolja, - kura ta 'pressjoni għolja arterjali pulmonari (pah) biex tittejjeb il-kapaċità ta' eżerċizzju u s-sintomi f'pazjenti bi klassi funzjonali tal-who iii. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. xi titjib intwera wkoll f'pazjenti b'pah klassi funzjonali who ii. tracleer huwa ndikat ukoll biex inaqqas in-numru ta ' ulċeri ġodda fis-swaba f'pazjenti bi sklerosi sistemika u l-ulċeri kontinwu tal-mard.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir - epatite Ċ, kronika - antivirali għal użu sistemiku - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 u 5. għall-vajrus tal-epatite Ċ (hcv) ġenotip attività speċifika, ara sezzjonijiet 4. 4 u 5. sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 u 5. għall-vajrus tal-epatite Ċ (hcv) ġenotip attività speċifika, ara sezzjonijiet 4. 4 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanoma - aġenti antineoplastiċi - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 u 5. kura awżiljarja tal-melanomadabrafenib flimkien ma trametinib huwa indikat għall-kura awżiljarja ta ' pazjenti adulti b'fażi iii melanoma bil-braf v600, wara li jitlesta r-risezzjoni. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - ciclesonide - sistema respiratorja, mediċini oħra għall-imblokkar tal-passaġġ tan-nifs mard, dawn il-prodotti - Żwiemel - għat-tnaqqis ta 'sinjali kliniċi ta' ekwini l-ażżma (li qabel kienet magħrufa bħala l-rikorrenti tal-passaġġ tan-nifs ostruzzjoni – (rao), fis-sajf tal-mergħa assoċjati rikorrenti tal-passaġġ tan-nifs ostruzzjoni – (spa-rao)).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - aġenti antineoplastiċi - erbitux hu indikat għall-kura ta 'pazjenti bil-riċettur tal-fattur tat-tkabbir epidermali (egfr) li jesprimu, ras tat-tip selvaġġ kanċer metastatiku tal-kolorektum:flimkien ma' irinotecan-kimoterapija bbażata fuq;fl-ewwel linja f'kombinazzjoni ma ' folfox;bħala sustanza waħidha f'pazjenti li jkunu fallew oxaliplatin u irinotecan bbażata fuq it-terapija, u li huma intolleranti għal irinotecan. għad-dettalji, ara t-taqsima 5. erbitux hu indikat għall-kura ta 'pazjenti b'kanċer taċ-ċelluli skwamużi tal-ras u l-għonq:f'kombinazzjoni ma' terapija bir-raġġi għal mard li jkun infirex lokalment;flimkien ma ' kimoterapija bbażata fuq platinum rikorrenti u/jew metastatika tal-marda.