Arsenic trioxide Mylan

On 14 April 2025, the European Commission withdrew the marketing authorisation for Arsenic trioxide Mylan (arsenic trioxide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mylan Ireland Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Arsenic trioxide Mylan was granted marketing authorisation in the EU on 1 April 2020 for the treatment of acute promyelocytic leukaemia (APL) in adults with newly diagnosed low or intermediate risk APL, and in adults with APL whose disease did not respond to previous treatment with a retinoid and cancer medicines, or when the disease came back after this type of treatment. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2025. Arsenic trioxide Mylan is a generic medicine of Trisenox. There are other generic medicinal products of Trisenox authorised and marketed in the EU.