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SMC ID Date Medicine Submission Type Indication
SMC2192 13/05/2019 dasatinib (Sprycel) Non submission The treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy.
SMC2142 08/04/2019 dasatinib (Sprycel) Abbreviated the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib
1170/16 12/09/2016 dasatinib (Sprycel) Full For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
370/07 12/09/2016 dasatinib (Sprycel) Resubmission For the treatment of adult patients with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.
1032/15 13/04/2015 ponatinib (Iclusig) Full Adult patients with: Chronic 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 mutation. Philadelphia 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.
910/13 09/02/2015 bosutinib (Bosulif) Resubmission Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
371/07 07/05/2007 dasatinib (Sprycel) Full Philadelphia chromosome positive (PH+) actue lymphoblastic leukaemia

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