Trisenox

RSS

arsenic trioxide

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

Overview

This is a summary of the European public assessment report (EPAR) for Trisenox. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Trisenox.

For practical information about using Trisenox, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 15/02/2018

Authorisation details

Product details
Name
Trisenox
Agency product number
EMEA/H/C/000388
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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
04/03/2002
Contact address
Swensweg 5
2031 GA Haarlem
Netherlands

Product information

06/12/2017 Trisenox - EMEA/H/C/000388 - IA/0066

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Trisenox 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 Pro-Myelocytic 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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