האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

pfizer europe ma eeig - glasdegib maleate - leukemija, myeloid, akutna - antineoplastična sredstva - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (aml) in adult patients who are not candidates for standard induction chemotherapy.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - antineoplastična sredstva - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidin - leukemija, myeloid, akutna - antineoplastična sredstva - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinalni stromalni tumorji - 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.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

amgen europe bv - sotorasib - karcinom, pljučni pljuč - antineoplastična sredstva - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - antineoplastična sredstva - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

האיחוד האירופי - סלובנית - 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 - 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. učinek glivec na izid kostnega mozga presaditev ni bilo določeno. 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. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment;, zdravljenje odraslih bolnikov z unresectable dermatofibrosarcoma protuberans (dfsp) in odraslih bolnikih s ponavljajočimi in / ali metastatskim dfsp, ki niso primerni za operacijo. v izobraževanju odraslih in pediatričnih bolnikov, učinkovitost glivec je na podlagi splošno hematoloških in postopek citogenetske stopnjo odziva in napredovanje-free survival v cml, na hematoloških in postopek citogenetske stopnjo odziva, v ph+ all, mds / mpd, na hematoloških stopnjo odziva, v hes / cel in na cilj stopnjo odziva pri odraslih bolnikih z unresectable in / ali metastatskim bistvo in dfsp in na ponovitev-free survival v adjuvant bistvo. izkušnje z glivec pri bolnikih z mds / mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejeno (glej poglavje 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

ab science s.a. - masitinib mesilate - antineoplastična sredstva - psi - zdravljenje neresetabilnih tumorjev mastocitov (razred 2 ali 3) s potrjenim mutiranim c-kit tirozin-kinaznim receptorjem.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

novartis europharm limited - ruksolitinib (kot fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastična sredstva - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (pv)jakavi je indiciran za zdravljenje odraslih bolnikov z polycythaemia vera, ki so odporne ali nestrpne hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

האיחוד האירופי - סלובנית - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastična sredstva - sprycel je primerna za zdravljenje pediatričnih bolnikov z:novo diagnosticiranih philadelphia kromosom-pozitivno kronične myelogenous levkemijo v kronično fazo (ph+ cml kt) ali ph+ cml cp odporne ali nestrpni, da pred terapijo, vključno z imatinib. na novo diagnosticirana ph+ acute lymphoblastic levkemijo (all) v kombinaciji s kemoterapijo. sprycel je indiciran za zdravljenje odraslih bolnikov z:novo diagnosticiranih philadelphia-kromosoma-pozitivne (ph+) kronična myelogenous levkemijo (cml) v kronično fazo;kronično, pospešeno ali pišu faze cml s odpornost ali nestrpnosti predhodno zdravljenje, vključno z imatinib mesilate;ph+ acute lymphoblastic levkemijo (all) in lymphoid pišu cml s odpornost ali nestrpnosti do pred terapijo. sprycel je primerna za zdravljenje pediatričnih bolnikov z:novo diagnosticirana ph+ cml v kronično fazo (ph+ cml-cp) ali ph+ cml-cp odporne ali nestrpni, da pred terapijo, vključno z imatinib.