Basic Information
Arsenic trioxide Mylan
Regulatory Information
EMEA/H/C/005235
April 1, 2020
January 30, 2020
6
May 6, 2025
Company Information
Ireland
Unit 35/36 Grange Parade Baldoye Industrial Estate Dublin 13
MYLAN IRELAND LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Arsenic trioxide Mylan 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 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.
Overview Summary
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.