Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

basilea pharmaceutica deutschland gmbh - isavuconazole - asperġillożi - cresemba huwa indikat fl-adulti għall-kura ta': invażivi aspergillosismucormycosis fil-pazjenti li għalihom amphotericin b huwa inappropriateconsideration għandha tingħata lill-gwida uffiċjali dwar l-użu xieraq ta ' mediċini antifungali.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochloride - vomiting; neoplasms; nausea; cancer - anti-emetiċi u anti-nawżjanti, - akynzeo huwa indikat fl-adulti għall -: il-prevenzjoni tal-akuta u ttardjata dardir u r-rimettar assoċjati mal ferm emetoġenika bbażata fuq cisplatin kimoterapija tal-kanċer. il-prevenzjoni ta akuta u ttardjata'nawseja u rimettar assoċjati ma'kimoterapija tal-kanċer moderatament emetoġenika.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - midazolam - epilessija - psikolettiċi - kura ta 'attakki fit-tul, akuti u konvulsivi fi trabi, tfal żgħar, tfal u adolexxenti (minn tliet xhur sa inqas minn 18-il sena). buccolam għandu jintuża biss mill-ġenituri / dawk li jieħdu ħsiebhom fejn il-pazjent ikun ġie dijanjostikat li jkollhom l-epilessija. għat-trabi ta 'bejn tlieta u sitt xhur ta' l-età, it-trattament għandu jiġi fi sptar fejn il-monitoraġġ huwa possibbli u huwa disponibbli tagħmir ta ' risuxxitazzjoni.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

merck sharp & dohme b.v. - indinavir sulphate ethanolate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - crixivan huwa indikat flimkien ma 'analogi ta' nucleoside antiretrovirali għat-trattament ta 'adulti infettati bl-hiv-1.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

serb sa - hydroxocobalamin - avvelenament - il-prodotti terapewtiċi l-oħra kollha - trattament ta 'avvelenament magħruf jew suspettat ta' cyanide. cyanokit għandu jingħata flimkien ma adegwati ta ' dekontaminazzjoni u miżuri ta'appoġġ.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

orion corporation - dexmedetomidine hydrochloride - sedazzjoni konxja - psikolettiċi - għal sedazzjoni ta 'pazjenti ta' unità ta 'kura intensiva għall-adulti li jeħtieġu livell ta' sedazzjoni mhux aktar profond milli tqanqal b'reazzjoni għal stimulazzjoni verbali (li tikkorrispondi għal richmond agitation-sedation scale (rass) 0 sa -3).

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - aġenti antineoplastiċi - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. , l-effett ta 'glivec fuq l-eżitu ta' l-għadam-trapjant tal-mudullun għadu ma ġiex determinat. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja;, il-kura ta'pazjenti adulti li ma jistax jitneħħa dermatofibrosarcoma protuberans (dfsp) u pazjenti adulti bil-rikorrenti u / jew metastatiku dfsp li mhumiex eliġibbli għall-kirurġija. , f'pazjenti adulti u pedjatriċi, l-effikaċja ta 'glivec hija bbażata fuq globali ematoloġiċi u ċitoġenetiċi-rati ta' rispons u sopravivenza mingħajr progressjoni f'cml, fuq ematoloġiċi u ċitoġenetiċi-rati ta 'rispons f'ph+ all, mds / mpd, fuq il-rati ta' rispons ematoloġiku f'hes / cel u dwar l-objettiv tal-rati ta ' rispons fil-pazjenti adulti li ma jistax jitneħħa u / jew metastiku-gist u dfsp u dwar ir-rikorrenza-sopravivenza mingħajr progressjoni fl-adjuvant gist. l-esperjenza bi glivec f'pazjenti b'mds / mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna (ara taqsima 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

eisai gmbh - eribulin - breast neoplasms; liposarcoma - aġenti antineoplastiċi - monoterapija b'halaven hija indikata għat-trattament ta 'pazjenti b'kanċer tas-sider lokalment avvanzat jew metastatiku li għamel progress wara mill-inqas korsijiet kemoterapewtiċi għal mard avvanzat (ara sezzjoni 5. terapija ta 'qabel kellha tinkludi anthracycline u taxane sakemm il-pazjenti ma kinux adattati għal dawn it-trattamenti. halaven huwa indikat għall-kura ta ' pazjenti adulti li ma jistax jitneħħa pazjenti b'liposarkoma li kienu rċevew qabel terapija li jkun fiha anthracycline (sakemm ma jkunux addattati) għall-marda avvanzata jew metastatika (ara sezzjoni 5.

Avrupa Birliği - Maltaca - 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.

Avrupa Birliği - Maltaca - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. , l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.