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SMC ID Date Medicine Submission Type Indication
1325/18 12/03/2018 nilotinib (Tasigna) Non submission

In paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase. In paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib
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.
709/11 08/08/2011 nilotinib (Tasigna) Full For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.
440/08 09/06/2008 nilotinib (Tasigna) Full For the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML)

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