Европейски съюз - малтийски - EMA (European Medicines Agency)

pfizer europe ma eeig  - palbociclib - neoplażmi tas-sider - aġenti antineoplastiċi - ibrance huwa indikat għall-kura ta 'l-ormon tat-riċettur (hr) pożittiv, 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;flimkien ma ' fulvestrant f'nisa li kienu rċevew qabel terapija endokrinali. fil - pre- jew perimenopausal-nisa, l-endokrinali it-terapija għandha tingħata flimkien ma ' ormon luteinizing releasing hormone (lhrh) agonist.

Европейски съюз - малтийски - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. ara t-taqsimiet 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Европейски съюз - малтийски - EMA (European Medicines Agency)

csl behring gmbh - albutrepenonacog alfa - hemofilja b - sustanzi kontra l-emorraġija - trattament u profilassi ta 'fsada f'pazjenti b'emofilja b (defiċjenza konġenitali tal-fattur ix).

Европейски съюз - малтийски - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mukosite - il-prodotti terapewtiċi l-oħra kollha - kepivance huwa indikat li tnaqqas l-inċidenza, it-tul u s-severità tal-mucositis orali fil-pazjenti adulti ma malignancies ħematoloġiċi li jirċievu radiochemotherapy ta ' myeloablative assoċjati ma ' l-inċidenza għolja ta ' mucositis ħorox u li jeħtieġu haematopoietic-zokk-ċelloli awtoloġiċi appoġġ.

Европейски съюз - малтийски - EMA (European Medicines Agency)

teva b.v. - lamivudine - epatite b, kronika - antivirali għal użu sistemiku - lamivudine teva huwa indikat għall-kura ta 'epatite b kronika f'adulti b': mard tal-fwied kumpensat u b'evidenza ta ' replikazzjoni virali attiva, persistenti elevati fis-serum alanine aminotransferase (alt) livelli u evidenza istoloġika ta'infjammazzjoni tal-fwied attiva u / jew fibrożi. il-bidu tal-kura b'lamivudine għandhom jiġu kkunsidrati biss meta l-użu ta ' sustanza antivirali alternattiva bl-ogħla ġenetiċi barriera ma tkunx disponibbli jew ikun xieraq (ara sezzjoni 5.

Европейски съюз - малтийски - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - lamivudine - epatite b, kronika - antivirali għal użu sistemiku - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. il-bidu tal-kura b'lamivudine għandhom jiġu kkunsidrati biss meta l-użu ta ' sustanza antivirali alternattiva bl-ogħla ġenetiċi barriera ma tkunx disponibbli jew ikun xieraq;, mard tal-fwied dekompensat flimkien mal-tieni aġent mingħajr kross-reżistenza għal lamivudine.

Европейски съюз - малтийски - EMA (European Medicines Agency)

pfizer europe ma eeig - moroctocog alfa - hemofilja a - sustanzi kontra l-emorraġija - trattament u profilassi ta 'fsada f'pazjenti b'emofilja a (nuqqas konġenitali ta' fattur viii). refacto af hu adattat għall-użu fl-adulti u t-tfal ta ' kull età, inkluż trabi tat-twelid. refacto af ma fih l-von willebrand il-fattur, u għaldaqstant mhuwiex indikat fil-von willebrand-marda tal -.

Европейски съюз - малтийски - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - idebenone - atrofija ottika, ereditarja, leber - psikostimulanti oħrajn u nootropics, psychoanaleptics, - raxone huwa indikat għall-kura ta 'indeboliment tal-vista f'pazjenti adolexxenti u adulti b'neurpatija ottika ereditarja leber (lhon).

Европейски съюз - малтийски - EMA (European Medicines Agency)

takeda pharma a/s - ferumoxytol - anemia; kidney failure, chronic - oħra antianemic preparazzjonijiet - rienso huwa indikat għall-kura ġol-vina ta 'anemija ta' defiċjenza tal-ħadid f'pazjenti adulti b'mard kroniku tal-kliewi (ckd). id-dijanjożi ta 'defiċjenza ta' ħadid għandha tkun ibbażata fuq testijiet tal-laboratorju xierqa (ara sezzjoni 4.

Европейски съюз - малтийски - EMA (European Medicines Agency)

gilead sciences international limited - cidofovir - cytomegalovirus retinite - antivirali għal użu sistemiku - vistide huwa indikat għall-kura ta 'retinite b'cytomegalovirus f'pazjenti b'sindromu ta' immunodefiċjenza miksuba (aids) u mingħajr disfunzjoni tal-kliewi. vistide għandu jintuża biss meta aġenti oħra huma kkunsidrati bħala mhux adattati.