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🇪🇺EU · EMAAuthorisedATC: L01XX27

Arsenic trioxide medac(arsenic trioxide)

Leukemia, Promyelocytic, Acute

Marketing Authorisation Holder: medac Gesellschaft für klinische Spezialpräparate mbH

EMA Authorisation: 17/09/2020

INN: arsenic trioxide

Indication

Arsenic trioxide medac 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/?l) 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?) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.