Unjoni Ewropea - Malti - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - limfoma, mantle-cell - aġenti antineoplastiċi - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - aġenti antineoplastiċi - imatinib koanaa is indicated for the treatment ofadult 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-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. 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. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - il-prodotti terapewtiċi l-oħra kollha - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - lewkimja, linfokitika, kronika, b-Ċellula - antikorpi monoklonali - ma kienux trattati qabel lewkimja limfoċitika kronika (cll): arzerra flimkien ma 'chlorambucil jew bendamustine huwa indikat għall-kura ta' pazjenti b'cll li ma rċevew terapija minn qabel u li mhumiex eliġibbli għall-fludarabine-terapija bbażata fuq. rkadew cll: arzerra huwa indikat flimkien ma 'fludarabine u cyclophosphamide għat-trattament ta' pazjenti adulti b'all rikadut cll. refrattarji cll: arzerra huwa indikat għall-kura ta cll f'pazjenti li huma refrattarji għal pazjenti b'b-ll u alemtuzumab.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - l-amlodipina, valsartan, hydrochlorothiazide - pressjoni għolja - antagonisti ta 'angiotensin ii, kombinazzjonijiet, aġenti li jaġixxu fuq is-sistema renin-anġjotensin, antagonisti ta' angiotensin ii u calcium channel blockers - trattament ta ' l-ipertensjoni essenzjali bħala terapija ta ' sostituzzjoni fil-pazjenti adulti l-pressjoni tad-demm tagħhom huwa kontrollat adegwatament dwar il-kombinazzjoni ta ' amlodipine, valsartan u idrochlorothiazide (hct), meħuda bħala tliet formulazzjonijiet ta ' wieħed il-komponent jew bħala a doppju-komponent u formulazzjoni wieħed-komponent.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabine - lewkimja, myeloid - aġenti antineoplastiċi - trattament tal-pazjenti adulti ma intomx ġodda de novo jew sekondarja akuta myeloid lewċemja (aml), skond il-klassifika ta ' l-organizzazzjoni dinjija tas-saħħa (who), li ma jkunux dawk il-kandidati għall-induzzjoni standard chemotherapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - valsartan, hydrochlorothiazide, amlodipine besilate - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta ' l-ipertensjoni essenzjali bħala terapija ta ' sostituzzjoni fil-pazjenti adulti l-pressjoni tad-demm tagħhom huwa kontrollat adegwatament dwar il-kombinazzjoni ta ' amlodipine, valsartan u idrochlorothiazide (hct), meħuda bħala tliet formulazzjonijiet ta ' wieħed il-komponent jew bħala a doppju-komponent u formulazzjoni wieħed-komponent.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

teva pharma b.v. - docetaxel - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - aġenti antineoplastiċi - tas-sider cancerdocetaxel teva pharma monoterapija hija indikata għat-trattament ta 'pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment ta' terapija ċitotossika. kemjoterapija preċedenti kellha tinkludi anthracycline jew aġent alkilanti. mhux żgħar tal-pulmun taċ-ċelluli cancerdocetaxel teva pharma huwa indikat għall-kura ta ' pazjenti b'lokalment avvanzat jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelloli tal-kanċer wara l-falliment tal-kimoterapija qabel. docetaxel teva pharma flimkien ma 'cisplatin huwa indikat għat-trattament ta' pazjenti li ma jistax jitneħħa, avvanzat lokalment jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelluli tal-kanċer, f'pazjenti li ma kinux ħadu qabel terapija ċitotossika għal din il-kundizzjoni. - prostata cancerdocetaxel teva pharma flimkien ma 'prednisone jew prednisolone huwa indikat għat-trattament ta' pazjenti bl-ormon tat-refrattarji kanċer metastatiku tal-prostata.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - valsartan, hydrochlorothiazide, amlodipine besilate - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta ' l-ipertensjoni essenzjali bħala terapija ta ' sostituzzjoni fil-pazjenti adulti l-pressjoni tad-demm tagħhom huwa kontrollat adegwatament dwar il-kombinazzjoni ta ' amlodipine, valsartan u idrochlorothiazide (hct), meħuda bħala tliet formulazzjonijiet ta ' wieħed il-komponent jew bħala a doppju-komponent u formulazzjoni wieħed-komponent.