Glivec 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

glivec

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - 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. učinak Гливека na ishod transplantacije koštane srži još nije određen. 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. pacijenti koji imaju niske ili vrlo nizak rizik recidiva ne bi trebali primati adjuvantne terapije; liječenje odraslih bolesnika s метастатической выбухающей dermatofibrosarcoma (dfsp) i odraslih pacijenata s relaps i / ili метастатической dfsp, koji nemaju pravo na operaciju. u odrasle osobe i pedijatrijska bolesnika, učinkovitosti glivec se temelji na zajedničkim гематологических i цитогенетических odgovora i preživljavanja bez progresije kod kml, na гематологический i цитогенетический odgovor cijene na ph+ all, mds / rafinerija, na гематологические indikatori odgovora u hes / cel i objektivnih odgovora kod odraslih pacijenata s неоперабельными i / ili метастатическими gist i dfsp i na безрецидивную stopa preživljavanja pri adjuvantne bit. iskustvo glivec u bolesnika s mds / rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen (vidi odjeljak 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

Tasigna 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

tasigna

novartis europharm limited - nilotinib - leukemija, mijelogeni, kronični, bcr-abl pozitivan - antineoplastična sredstva - tasigna indiciran za liječenje:i pedijatrijski bolesne odrasle osobe s prvi put utvrđenom pozitivnom Филадельфийской hromozoma u kroničnih миелогенной leukemije (kml) u kroničnu fazu,pedijatrijska bolesnika s pozitivnom Филадельфийской hromozoma u kroničnih fazi kml s inzulinska ili netrpeljivosti ranije terapiju, uključujući imatinib. tasigna indiciran za liječenje:i pedijatrijski bolesne odrasle osobe s prvi put utvrđenom pozitivnom Филадельфийской hromozoma u kroničnih миелогенной leukemije (kml) u kroničnu fazu kod odraslih pacijenata s kroničnom fazi i ubrzano izlučivanje Филадельфийской hromozoma pozitivan kml s inzulinska ili netrpeljivosti ranije terapiju, uključujući imatinib. učinkovitost podataka u bolesnika s kml u бластного kriza nisu dostupni,pedijatrijska bolesnika s kroničnim faze kml pozitivnom Филадельфийской hromozoma kada je otpornost ili nepodnošenje u prethodnom terapiju, uključujući imatinib.

Bosulif 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

bosulif

pfizer europe ma eeig - bosutinib (kao monohidrat) - leukemija, mieloid - antineoplastic agents, protein kinase inhibitors - bosulif indiciran za liječenje odraslih bolesnika s prvi put prijavljene kronične faze (cp) kromosoma-pozitivnim philadelphia kronične миелогенной leukemije (ph+ kml). srijeda, ubrzana faza (ap), i бластном (bp) ph+ kml, prethodno liječenih jedan ili više inhibitora тирозинкиназы(s) [тки(e)] i za koga imatinib, nilotinib i dasatinib ne uzeti u obzir odgovarajuće mogućnosti liječenja .

Sutent 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

sutent

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastična sredstva - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

Sunitinib Accord 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

sunitinib accord

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastična sredstva - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Stivarga 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

stivarga

bayer pharma ag - regorafenib - kolorektalne neoplazme - antineoplastic agents, protein kinase inhibitors - Стиварга prikazan kao monoterapija za liječenje odraslih bolesnika s metastaze колоректальным raka (КРР), koji su ranije već bili tretirani, ili ne smatraju se kandidatima za primjenjuju metode liječenja, a među njima fluoropyrimidine na temelju kemoterapije, anti-vegf terapije i anti-egfr terapije;неоперабельными ili метастатическими гастроинтестинальными стромальными tumora (ГИСО), koji su razvili ili netolerantan na liječenje imatinib i сунитиниб;гепатоцеллюлярная karcinom (hcc), koje su prethodno liječenih Сорафениб.

Qinlock 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

qinlock

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumori gastrointestinalnog stroma - antineoplastična sredstva - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Sprycel 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

sprycel

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - Спрайсел indiciran za liječenje pedijatrijska bolesnika:prvi put otkrivene philadelphia kromosoma-pozitivan kroničnog миелоидного leukemije u fazi kroničnog (ph+ kml cp) ili ph+ kml usp stabilnost ili netrpeljivosti ranije terapiju, uključujući imatinib. nedavno dijagnosticiran, ph+ akutne limfoblastične leukemije (all) u kombinaciji s kemoterapijom. Спрайсел indiciran za liječenje odraslih bolesnika s je prvi put dijagnosticiran philadelphia kromosoma-pozitivan (ph+) kronične миелоидного leukemije (kml) u fazi kroničnog;kronične, ubrzani ili eksplozije fazi kml s inzulinska ili netrpeljivosti ranije terapiju, uključujući imatinib мезилат;ph+ akutne limfoblastične leukemije (all) i лимфоидных eksplozije kml pri otpornost ili nepodnošenje prethodne terapije. Спрайсел indiciran za liječenje pedijatrijska bolesnika s je prvi put dijagnosticiran ph+ kml u kroničnu fazu (ph+ kml-cp) ili ph+ kml-cp s tolerancije ili netrpeljivosti ranije terapiju, uključujući imatinib.

Dasatinib Accordpharma 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

dasatinib accordpharma

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.