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SMC ID Date Medicine Submission Type Indication
SMC2181 08/07/2019 arsenic trioxide (Trisenox) Resubmission

For induction of remission and consolidation in adult patients with: • Newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 x 103/µl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.

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