- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Arsenic trioxide Mylan
- Active substance
- Arsenic trioxide
- International non-proprietary name (INN) or common name
- arsenic trioxide
- Therapeutic area (MeSH)
- Leukemia, Promyelocytic, Acute
- Anatomical therapeutic chemical (ATC) code
- L01XX27
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.