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Marketing authorization without orphan designation - Europe

  • Tradename: Arsenic Trioxide Accord
  • ATC code : L01XX27
  • EU Number: EU/1/19/1398
  • MA date : 14/11/2019
  • European Public Assessment Report

Therapeutic indication

Arsenic trioxide is indicated 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 acute promyelocytic leukaemia (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 promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

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