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SMC ID Date Medicine Submission Type Indication
SMC2821 11/08/2025 ripretinib (Qinlock) Resubmission

Treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
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
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
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.
1031/15 13/04/2015 regorafenib (Stivarga) Full Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
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.
923/13 07/10/2013 imatinib (Glivec) Non submission Treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
584/09 13/09/2010 imatinib (Glivec) Resubmission GIST
275/06 09/11/2009 sunitinib (Sutent) Resubmission Unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.
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)
428/07 10/12/2007 imatinib (Glivec) Non submission for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet -derived growth factor receptor (PDGFR) gene re-arrangements
427/07 10/12/2007 imatinib (Glivec) Non submission for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (PH + ALL) in combination with chemotherapy
426/07 10/12/2007 imatinib (Glivec) Non submission for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) as monotherapy
429/07 10/12/2007 imatinib (Glivec) Non submission for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement
430/07 10/12/2007 imatinib (Glivec) Non submission for the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery
275/06 09/10/2006 sunitinib 50mg capsule (Sutent) Full Unresectable and/or metastatic malignant gastrointestinal stromal tumour
26/02 10/01/2003 Imatinib (Glivec®) Full Chronic myeloid leukaemia
08/02 09/08/2002 imatinib (Glivec) Full Gastrointestinal stromal tumours
01/02 08/03/2002 imatinib (Glivec) Full Chronic myeloid leukaemia

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