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EMA withdrawal · 2025-05-06

EMA Withdrawn: Arsenic trioxide Mylan (arsenic trioxide) — Mylan Ireland Limited

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Summary

The EMA has withdrawn the arsenic trioxide product Arsenic trioxide Mylan (Mylan Ireland Limited) used for acute promyelocytic leukemia.

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Diseases / indications

Drugs mentioned

  • Arsenic trioxide Mylan (arsenic trioxide)

Snippet

Status: Withdrawn. Therapeutic area: Leukemia, Promyelocytic, Acute. MAH: Mylan Ireland Limited. Decision date: 14/01/2025