Sprycel Avrupa Birliği - Macarca - EMA (European Medicines Agency)

sprycel

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - daganatellenes szerek - a sprycel-t javallott a gyermekgyógyászati betegek:az újonnan diagnosztizált philadelphia kromoszóma-pozitív krónikus myeloid leukaemia krónikus fázis (ph+ cml cp), vagy ph+ cml cp rezisztens vagy intoleráns előzetes beleértve az imatinib terápia. újonnan diagnosztizált ph+ akut limfoblasztos leukémia (all) kemoterápiával kombinálva. a sprycel-t javallott a felnőtt betegek kezelésére:újonnan diagnosztizált philadelphia kromoszóma pozitív (ph+) krónikus myeloid leukaemia (cml) a krónikus fázisú;krónikus, gyorsított vagy robbanás fázisú cml-ben a rezisztencia vagy intolerancia előzetes kezelés beleértve az imatinib mesilate;ph+ akut limfoblasztos leukémia (all), valamint a lymphoid robbanás cml a rezisztencia vagy intolerancia előzetes kezelés. a sprycel-t javallott a gyermekgyógyászati betegek:az újonnan diagnosztizált ph+ cml krónikus fázisában (ph+ cml-cp), vagy ph+ cml-cp rezisztens vagy intoleráns előzetes beleértve az imatinib terápia.

Dasatinib Accordpharma Avrupa Birliği - Macarca - EMA (European Medicines Agency)

dasatinib accordpharma

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

Iclusig Avrupa Birliği - Macarca - 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. lásd a 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.