Basic Information
L01XX27
arsenic trioxide
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.
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.
Active Substances (2)
Arsenic trioxide
Arsenic trioxide
Documents (9)
Arsenic trioxide Mylan : EPAR - Public assessment report
April 17, 2020
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Arsenic trioxide Mylan : EPAR - Risk-management-plan summary
April 17, 2020
RISK_MANAGEMENT_PLAN_SUMMARY
Arsenic trioxide Mylan : EPAR - Public assessment report
April 17, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Arsenic trioxide Mylan : EPAR - Medicine overview
April 17, 2020
OVERVIEW_DOCUMENT
CHMP summary of positive opinion for Arsenic trioxide Mylan
January 31, 2020
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Arsenic trioxide Mylan
January 31, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Arsenic trioxide Mylan : EPAR - All Authorised presentations
April 17, 2020
AUTHORISED_PRESENTATIONS
Arsenic trioxide Mylan : EPAR - Product information
April 17, 2020
DRUG_PRODUCT_INFORMATION
Arsenic trioxide Mylan : EPAR - Procedural steps taken and scientific information after authorisation
May 25, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
What are the benefits and risks of Arsenic trioxide Mylan?
Answer
Because Arsenic trioxide Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
How is Arsenic trioxide Mylan used?
Answer
Arsenic trioxide Mylan can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias. It is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The infusion should last one to two hours, but it may last longer if the patient has certain side effects.
The recommended dose of Arsenic trioxide Mylan depends on the body weight of the patient. The treatment is divided into 2 phases: induction and consolidation.
During the induction phase, Arsenic trioxide Mylan is given every day until there are signs that the treatment is working (when the bone marrow no longer contains any leukaemia cells). If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.
During the consolidation phase, Arsenic trioxide Mylan is given once a day for five days, followed by a two-day break, repeated for four or five weeks. The number of times these cycles are repeated depends on whether patients have received previous treatment or not.
For more information about using Arsenic trioxide Mylan, see the package leaflet or contact your doctor or pharmacist.
Question
How does Arsenic trioxide Mylan work?
Answer
The active substance in Arsenic trioxide Mylan, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia. The way it works in this disease is not completely understood. It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.
Question
Why is Arsenic trioxide Mylan authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Mylan has been shown to be comparable to Trisenox. Therefore, the Agency’s view was that, as for Trisenox, the benefits of Arsenic trioxide Mylan outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Arsenic trioxide Mylan?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Mylan have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Arsenic trioxide Mylan are continuously monitored. Side effects reported with Arsenic trioxide Mylan are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Arsenic trioxide Mylan
Answer
Arsenic trioxide Mylan received a marketing authorisation valid throughout the EU on 01 April 2020.
Question
How has Arsenic trioxide Mylan been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Mylan.
As for every medicine, the company provided studies on the quality of Arsenic trioxide Mylan. There was no need for ‘bioequivalence’ studies to investigate whether Arsenic trioxide Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Arsenic trioxide Mylan is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.