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SMC ID Date Medicine Submission Type Indication
SMC2615 11/03/2024 ivosidenib (Tibsovo) Full

In combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.
SMC2533 10/07/2023 azacitidine oral (Onureg) Full

Maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).
SMC2412 11/04/2022 venetoclax (Venclyxto) Full

In combination with a hypomethylating agent (HMA) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy (IC).
1175/16 11/07/2016 azacitidine (Vidaza) Non submission Treatment of adult patients aged 65 years or older who are not eligible for haematopoietic stem cell transplantation (HSCT) with acute myeloid leukaemia (AML) with >30% marrow blasts according to the World Health Organisation (WHO) classification.
589/09 12/09/2011 azacitidine (Vidaza) Resubmission Treatment of adult patients not eligible for haematopoietic stem cell transplantation with: myelodysplastic syndrome / chronic myelomonocytic leukaemia / acute myeloid leukaemia

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