Trisenox
arsenic trioxide
Table of contents
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.
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 |
31
|
Date of issue of marketing authorisation valid throughout the European Union |
05/03/2002
|
Contact address |
Swensweg 5
2031 GA Haarlem Netherlands |
Product information
25/05/2023 Trisenox - EMEA/H/C/000388 - IB/0080
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).
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.