Arsenic trioxide Mylan

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Withdrawn

This medicine's authorisation has been withdrawn

arsenic trioxide
MedicineHumanWithdrawn
  • 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. 

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Product information

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Latest procedure affecting product information: IB/0013/G
14/01/2025
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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).

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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

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