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 10/03/2022

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
Publication details
Marketing-authorisation holder
Teva B.V.
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
05/03/2002
Contact address
Swensweg 5
2031 GA Haarlem
Netherlands

Product information

22/02/2022 Trisenox - EMEA/H/C/000388 - IB/0077/G

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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