Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - immunosoppressanti - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - abatacept - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid - immunosoppressanti - rewmatika arthritisorencia, flimkien ma 'methotrexate, huwa indikat għall -: l-kura moderata għal severa ta' artrite rewmatojde attiva (ra) f'pazjenti adulti li kellhom rispons inadegwat għat-terapija preċedenti b'wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards), inkluż methotrexate (mtx) jew fattur tan-nekrożi tat-tumur (tnf)-alpha inibitur. il-kura ta ' ħafna attiva u progressiva tal-marda fil-pazjenti adulti bl-artrite rewmatojde li ma kinux ittrattati qabel b'methotrexate. it-tnaqqis fil-progressjoni tal-ħsara fil-ġogi u t-titjib tal-funzjoni fiżika ġiet ippruvata waqt trattament ikkombinat ta 'abatacept ma' methotrexate. psorjatika arthritisorencia, waħdu jew f'taħlita ma 'methotrexate (mtx), huwa indikat għall-kura ta' artrite psorjatika attiva (psa) f'pazjenti adulti meta r-rispons għall-preċedenti dmard terapija inkluż mtx kienet inadegwata, u li għalihom il-addizzjonali terapija sistemika għal psorjatika leżjonijiet fil-ġilda mhix meħtieġa. idjopatika poliartikulari taż-żagħżagħ arthritisorencia flimkien ma 'methotrexate huwa indikat għall-kura ta attiva moderata għal severa artrite idjopatika ġuvenili poliartikulari (pjia) f'pazjenti pedjatriċi ta' 2-il sena u aktar li kellhom rispons mhux adegwat għall-preċedenti terapija dmard. orencia jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta l-kura b'methotrexate ma tkunx tajba.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - emoglobinurja, paroxysmal - immunosuppressanti selettivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - aġenti antineoplastiċi - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - mard tal-Ħażna tal-glukoġen tat-tip ii - prodotti oħra alimentari u metaboliżmu - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - elotuzumab - majloma multipla - aġenti antineoplastiċi - empliciti huwa indikat, flimkien ma 'lenalidomide u dexamethasone għall-kura ta' majeloma multipla f'pazjenti adulti li jkunu rċevew mill-anqas terapija waħda qabel (ara sezzjonijiet 4. 2 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - mard tal-Ħażna tal-glukoġen tat-tip ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - mavacamten - cardiomyopathy, hypertrophic - preparazzjonijiet kardijaċi oħrajn - treatment of symptomatic obstructive hypertrophic cardiomyopathy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - entecavir - epatite b, kronika - antivirali għal użu sistemiku - baraclude huwa indikat għat-trattament ta kronika tal-virus epatite b (hbv) fl-adulti bil:mard tal-fwied ikkumpensat u evidenza ta 'replikazzjoni virali attiva, persistenti elevati fis-serum alanine aminotransferase (alt) livelli u evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi;mard tal-fwied dekompensat. kemm għall-kkumpensati u mard tal-fwied dikumpensat, din l-indikazzjoni hija bbażata fuq tagħrif minn provi kliniċi f'pazjenti li huma nucleoside naïve b'hbeag pożittiv u hbeag negattiv li jaqbadhom infezzjoni hbv. fir-rigward ta 'pazjenti b'epatite b refrattarja għal lamivudine.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mendelikabs europe ltd - nitisinone - tyrosinemias - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - trattament ta ' l-adulti u paediatric (fi kwalunkwe medda ta ' età) pazjenti ma dijanjosi konfermati ta ' tyrosinemia ereditarji tat-tip 1 (ht 1) flimkien ma ' restrizzjoni tad-dieta ta ' tyrosine u fenilalanina.