Европейски съюз - малтийски - EMA (European Medicines Agency)

janssen-cilag international nv - guselkumab - psorajiżi - immunosoppressanti - plaque psoriasis tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritis tremfya, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis 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.

Европейски съюз - малтийски - EMA (European Medicines Agency)

pierre fabre medicament - neratinib - neoplażmi tas-sider - aġenti antineoplastiċi - nerlynx huwa indikat għall-estiż kura awżiljarja ta 'pazjenti adulti bil-istadju bikri pożittiv għar-riċetturi tal-ormon tat-her2-overexpressed/amplifikati-kanċer tas-sider u li huma anqas minn sena mill-tlestija ta'qabel l-adjuvant' trastuzumab terapija bbażata fuq.

Европейски съюз - малтийски - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; psoriasis; arthritis, psoriatic; spondylitis, ankylosing; uveitis; colitis, ulcerative; crohn disease - immunosoppressanti - rewmatika arthritiskromeya 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. kromeya 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. idjopatika ġuvenili arthritispolyarticular idjopatika ġuvenili arthritiskromeya flimkien ma 'methotrexate huwa indikat għall-kura tal-attivi-artrite idjopatika ġuvenili poliartikulari, f'pazjenti mill-età ta' 2 snin li kellhom rispons inadegwat għal wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards). idacio jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta titkompla l-kura b'methotrexate ma tkunx tajba (għall-effikaċja fil-monoterapija ara sezzjoni 5. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. enthesitis relatati mal-arthritiskromeya huwa indikat għall-kura tal-attivi-artrite assoċjata ma'entesite fil-pazjenti, l-età ta ' 6 snin u akbar, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal, terapija konvenzjonali (ara sezzjoni 5. assjali spondyloarthritisankylosing ankilosanti (as)kromeya huwa indikat għall-kura ta ' adulti li jbatu minn ankylosing spondylitis attiva li kellhom rispons mhux adekwat għat-terapija. assjali aksjali mingħajr evidenza radjografika ta askromeya huwa indikat għall-kura ta 'adulti li jbatu minn assjali aksjali mingħajr evidenza radjografika ta' kif iżda bil-għan sinjali ta 'infjammazzjoni minn crp għoli u/jew ta' l-mri, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal mediċini anti-infjammatorji. psorjatika arthritiskromeya 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 ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' x-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda (ara sezzjoni 5. 1) u li jtejjeb il-funzjoni fiżika. psoriasiskromeya huwa indikat għall-kura moderata għal severa ta ' psorjasi tal-plakka kronika f'pazjenti adulti li huma kandidati għat-terapija sistemika. pedjatrika tal-plakka psoriasiskromeya 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. crohn diseasekromeya 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. pedjatriċi crohn diseasekromeya huwa indikat għall-kura ta attiva minn moderata sa gravi marda ta 'crohn f'pazjenti pedjatriċi (mill-età ta' 6 snin) li kellhom rispons mhux adekwat għat-terapija konvenzjonali, inkluż primarja nutrizzjoni-terapija u xi corticosteroid u/jew immunomodulatur, jew li ma jifilħux jew għandhom kontra-indikazzjonijiet għal dawn it-terapiji. kolite colitiskromeya huwa indikat għall-kura ta attiva minn moderata sa gravi kolite bl-ulċeri fil-pazjenti adulti li kellhom rispons mhux adekwat għat-terapija konvenzjonali, inkluż kortikosterojdi u 6 mercaptopurine (6-mp) jew azathioprine (aza), jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. uveitiskromeya huwa indikat għall-kura ta mhux infettiv intermedji, posterjuri u panuveitis f'pazjenti adulti li kellhom rispons mhux adegwat għall-kortikosterojdi, il-pazjenti fil-bżonn ta ' kortikosterojdi li ma jitilfux potassium, jew min-kura bil-kortikosterojdi huwa xieraq. pedjatriċi uveitiskromeya huwa indikat għall-kura ta kronika pedjatrika mhux infettiv uveite anterjuri f'pazjenti li għandhom minn 2-il sena li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal terapiji konvenzjonali, jew li terapija konvenzjonali ma tkunx xierqa.

Европейски съюз - малтийски - EMA (European Medicines Agency)

novo nordisk a/s - turoctocog alfa pegol - hemofilja a - sustanzi kontra l-emorraġija - trattament u profilassi ta 'fsada f'pazjenti ta' 12-il sena 'l fuq b'emofilja a (nuqqas konġenitali ta' fattur viii).

Европейски съюз - малтийски - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - sera immuni u immunoglobulini, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. ara t-taqsimiet 4. 4 u 5.

Европейски съюз - малтийски - EMA (European Medicines Agency)

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - sera immuni u immunoglobulini, - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Европейски съюз - малтийски - EMA (European Medicines Agency)

amgen europe bv - sotorasib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

Европейски съюз - малтийски - EMA (European Medicines Agency)

astrazeneca ab - tixagevimab, cilgavimab - covid-19 virus infection - prevention of covid-19.

Европейски съюз - малтийски - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - infezzjonijiet pnewmokokkali - vaċċini - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. ara t-taqsimiet 4. 4 u 5. 1 għal informazzjoni dwar il-protezzjoni kontra serotipi pnewmokokkiċi speċifiċi. apexxnar should be used in accordance with official recommendations. .

Европейски съюз - малтийски - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunosoppressanti - 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.