Qinlock Uniunea Europeană - română - EMA (European Medicines Agency)

qinlock

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumorile stromale gastro-intestinale - agenți antineoplazici - 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.

Iclusig Uniunea Europeană - română - 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.

Sprycel Uniunea Europeană - română - 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.

Dasatinib Accordpharma Uniunea Europeană - română - EMA (European Medicines Agency)

dasatinib accordpharma

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - agenți antineoplazici - 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.