Sprycel Європейський Союз - румунська - EMA (European Medicines Agency)

sprycel

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - agenți antineoplazici - sprycel este indicat pentru tratamentul pacienților pediatrici cu:recent diagnosticat cu cromozom philadelphia pozitiv leucemie mieloidă cronică în fază cronică (lmc ph+ pc) sau lmc ph+ cp cu rezistență sau intoleranță la terapii anterioare, inclusiv imatinib. recent diagnosticat ph+ leucemie limfoblastică acută (all) în asociere cu chimioterapie. sprycel este indicat pentru tratamentul pacienților adulți cu:nou diagnosticate cromozom philadelphia pozitiv (ph+) leucemie mieloidă cronică (lmc) în fază cronică;cronică, accelerată sau lmc în fază blastică cu rezistență sau intoleranță la terapii anterioare, inclusiv la mesilat de imatinib;ph+ leucemie limfoblastică acută (all) și lmc în fază blastică limfoidă cu rezistență sau intoleranță la terapii anterioare. sprycel este indicat pentru tratamentul pacienților pediatrici cu:nou diagnosticate lmc ph+ în fază cronică (lmc ph+-cp) sau lmc ph+-cp cu rezistență sau intoleranță la terapii anterioare, inclusiv imatinib.

Imatinib Accord Європейський Союз - румунська - EMA (European Medicines Agency)

imatinib accord

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord 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-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. cu excepția nou diagnosticate în faza cronică a lgc, nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli. .

Iclusig Європейський Союз - румунська - EMA (European Medicines Agency)

iclusig

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. vezi secțiunile 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

SomaKit TOC Європейський Союз - румунська - EMA (European Medicines Agency)

somakit toc

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - produse radiofarmaceutice de diagnosticare - acest medicament este destinat exclusiv diagnosticului. după marcarea radioactivă cu galiu (68ga) soluție de clorură, soluția de galiu (68ga) edotreotide obținut este indicat pentru tomografia cu emisie de pozitroni (pet) și imagistica de somatostatina supraexprimarea receptorilor la pacienții adulți cu confirmată sau suspectată bine diferențiat gastro-enteropancreatic tumori neuroendocrine (gep-net) pentru localizarea primară a tumorii și a metastazelor acestora.

Lutathera Європейський Союз - румунська - EMA (European Medicines Agency)

lutathera

advanced accelerator applications - luteţiu (177lu) oxodotreotide - tumori neuroendocrine - alte produse radiofarmaceutice terapeutice - lutathera este indicat pentru tratamentul unresectable sau metastatic, progresivă, bine diferentiat (g1 și g2), somatostatina receptorilor pozitiv gastroenteropancreatic neuroendocrine tumori (gep‑nets) la adulti.