Arsenic trioxide Mylan

Withdrawn

This medicine's authorisation has been withdrawn

arsenic trioxide

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. 

Arsenic trioxide Mylan : EPAR - Medicine overview

Reference Number: EMA/64271/2020

Arsenic trioxide Mylan : EPAR - Risk-management-plan summary

Product information

Arsenic trioxide Mylan : EPAR - Product information

Arsenic trioxide Mylan : EPAR - All Authorised presentations

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 agents

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.

Authorisation details

• EMA product number:
  EMEA/H/C/005235
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Mylan Ireland Limited

  Unit 35/36; Grange Parade; Baldoye; Industrial Estate; Dublin 13; Ireland

• Opinion adopted:
  30/01/2020
• Marketing authorisation issued:
  01/04/2020
• Withdrawal of marketing authorisation:
  14/04/2025
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Arsenic trioxide Mylan : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Arsenic trioxide Mylan : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/638190/2019

CHMP summary of positive opinion for Arsenic trioxide Mylan

Adopted Reference Number: EMA/CHMP/28370/2020