Unió Europea - maltès - EMA (European Medicines Agency)

bayer ag - iloprost - pressjoni għolja, pulmonari - aġenti antitrombotiċi - kura ta 'pazjenti bi pressjoni għolja pulmonari primarja, ikklassifikata bħala klassi funzjonali iii ta' assoċjazzjoni tal-qalb ta 'new york, biex ittejjeb il-kapaċità u s-sintomi ta' eżerċizzju.

Unió Europea - maltès - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artrite, rewmatika - immunosoppressanti - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 u 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) 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. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Unió Europea - maltès - EMA (European Medicines Agency)

sanofi winthrop industrie - aflibercept - neoplażmi kolorettali - aġenti antineoplastiċi - kura tal-kanċer metastatiku tal-kolorektum (mcrc).

Unió Europea - maltès - EMA (European Medicines Agency)

novartis europharm limited - ribociclib succinate - neoplażmi tas-sider - aġenti antineoplastiċi - kisqali huwa indikat għall-kura ta 'nisa bl-ormon tat-riċettur (hr)‑pożittivi, tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2) negattivi lokalment avvanzata jew metastatika tal-kanċer tas-sider f'kumbinazzjoni ma' inibitur aromatase jew fulvestrant bħala inizjali endokrinali bbażata fuq it-terapija, jew f'nisa li kienu rċevew qabel terapija endokrinali. fil‑ pre- jew perimenopausal-nisa, l-endokrinali it-terapija għandha tingħata flimkien ma 'ormon ta' lutejniżżazzjoni‑releasing hormone (lhrh) agonist.

Unió Europea - maltès - EMA (European Medicines Agency)

mitsubishi pharma europe ltd - colestilan - iperfosfatemja - drogi għat-trattament ta 'iperkalimja u iperfosfatemija - il-kura ta 'iperfosfatemija f'pazjenti adulti b'mard tal-kliewi kroniku stadju 5 li jirċievu emodijalisi jew dijalisi peritoneali.

Unió Europea - maltès - 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).

Unió Europea - maltès - EMA (European Medicines Agency)

glaxosmithkline trading services limited - albiglutide - diabetes mellitus, tip 2 - drogi użati fid-dijabete - eperzan huwa indikat għat-trattament tad-dijabete tat-tip 2 mellitus fl-adulti biex itejbu l-kontroll gliċemiku bħala:monotherapywhen-dieta u l-eżerċizzju waħdu ma jipprovdux kontroll gliċemiku adegwat fil-pazjenti li għalihom l-użu ta ' metformin huwa kkunsidrat xieraq minħabba kontra-indikazzjonijiet jew intolleranza. add-on-kombinazzjoni therapyin flimkien ma'l-oħra tal-glukożju il-prodotti mediċinali li jbaxxu l inkluża l-insulina bażika, meta dawn, flimkien ma ' dieta u eżerċizzju, ma jipprovdux kontroll gliċemiku adegwat (ara sezzjoni 4. 4 u 5. 1 għad-data disponibbli dwar kombinazzjonijiet differenti).

Unió Europea - maltès - EMA (European Medicines Agency)

nps pharma holdings limited - ormon tal-paratirojde (rdna) - l-osteoporożi, il-menopawża - homeostasi tal-kalċju - trattament ta 'l-osteoporożi f'nisa wara l-menopawża f'riskju għoli ta' ksur (ara sezzjoni 5. Ġie muri tnaqqis sinifikanti fl-inċidenza ta 'ksur vertebrali, iżda mhux tal-ġenbejn.

Unió Europea - maltès - EMA (European Medicines Agency)

theramex ireland limited - teriparatide - l-osteoporożi - homeostasi tal-kalċju - livogiva is indicated in adults. trattament ta 'l-osteoporożi f'nisa wara l-menopawża u fl-irġiel b'riskju akbar ta' ksur. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. trattament ta 'osteoporożi assoċjat ma sostnut sistemika terapija bi glukokortikojdi f'nisa u l-irġiel f'riskju akbar ta' ksur.

Unió Europea - maltès - EMA (European Medicines Agency)

gilead sciences ireland uc - aztreonam lisina - cystic fibrosis; respiratory tract infections - antibatteriċi għal użu sistemiku, - cayston huwa indikat għat-terapija ta 'suppressjoni ta' infezzjonijiet pulmonari kroniċi minħabba pseudomonas aeruginosa f'pazjenti b'fibrożi ċistika (cf) ta '6 snin u aktar. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.