Arsenic trioxide Mylan

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arsenic trioxide

Authorised
This medicine is authorised for use in the European Union.

Overview

Arsenic trioxide Mylan is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation’ (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A).

Arsenic trioxide Mylan is used in:

  • patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA);
  • patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.

Arsenic trioxide Mylan is a ‘generic medicine’. This means that Arsenic trioxide Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Trisenox. For more information on generic medicines, see the question-and-answer document here.

Arsenic trioxide Mylan contains the active substance arsenic trioxide.

This EPAR was last updated on 17/04/2020

Authorisation details

Product details
Name
Arsenic trioxide Mylan
Agency product number
EMEA/H/C/005235
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
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Mylan Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
01/04/2020
Contact address

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

Product information

Arsenic trioxide Mylan - EMEA/H/C/005235 -

Contents

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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/μl) 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.

Assessment history

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