Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - adalimumab - hidradenitis suppurativa; psoriasis; uveitis; arthritis, rheumatoid; spondylitis, ankylosing; crohn disease; colitis, ulcerative; arthritis, psoriatic - immunosoppressanti, fattur alfa tan-necrożi tat-tumur (tnf-α) l-inibituri

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinacalcet hydrochloride - hyperparathyroidism, secondary; hypercalcemia - homeostasi tal-kalċju - il-kura ta 'iperparatirojdiżmu sekondarju (hpt) f'pazjenti b'mard renali fl-aħħar stadju (esrd) fuq terapija ta' dijalisi ta 'manteniment. cinacalcet mylan jista 'jintuża bħala parti minn kors terapewtiku li jinkludi binders tal-fosfat u/jew sterols ta' vitamina d, kif xieraq. tnaqqis ta 'iperkalċimja f'pazjenti b': - paratirojde carcinomaprimary hpt li għalihom parathyroidectomywould tkun indikata fuq il-bażi tal-livelli tal-kalċju fis-serum (kif definit mil-linji gwida ta ' kura rilevanti), iżda fejn paratirojdektomija mhiex klinikament xierqa jew kontraindikata.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan ireland limited - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - aġenti antineoplastiċi - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol, mometasone furoate - ażma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - bemrist breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bausch health ireland limited - methylnaltrexone bromide - opioid-related disorders; constipation - periferali tal-opioid ta ' l-antagonisti tar-riċettur - trattament ta 'stitikezza li tittieħed mill-opjojdi f'pazjenti b'mard avvanzat li qed jirċievu kura palljattiva meta r-rispons għat-terapija laxattiva normali ma kienx biżżejjed.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris healthcare limited - imiquimod - keratosis; keratosis, actinic - antibijotiċi u kimoterapewtiċi għal użu dermatoloġiku - zyclara huwa indikat għall-trattament topiku ta klinikament tipiku, mhux hyperkeratotic, mhux hypertrophic, viżibbli jew palpable keratosis actinic tal-wiċċ sħiħ jew scalp balding fl-adulti immunokompetenti meta huma għażliet oħra ta ' trattament topiku contraindicated jew inqas xierqa.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - antineoplastic agents, protein kinase inhibitors - gefitinib mylan huwa indikat bħala monoterapija għall-kura ta 'pazjenti adulti b'lokalment avvanzat jew dak metastatiku li mhux ta' ċelluli żgħar kanċer tal-pulmun (nsclc) b'mutazzjonijiet li jattivaw ta ' egfr‑tk.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - preparazzjonijiet antianemiċi - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - gotta - preparazzjonijiet antigout - krystexxa huwa indikat għall-kura ta ' severi gout debilitanti tophaceous kronika fil-pazjenti adulti li jistgħu wkoll ikollhom l-involviment konġunt erosive u li jkunu naqsu milli joqogħdu normalizzati serum uric acid b ' xanthine oxidase inibituri fil-massimu xieraq tad-doża jew li għalihom huma contraindicated dawn il-mediċini.