EPARs - Trisenox//Arsenic trioxide

FICHA FARMACOLÓGICA de Arsenic trioxide. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. ABRIL 29, 2009.-

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EPARs for authorised medicinal products for human use - Trisenox

Active Substance
Arsenic trioxide
International Nonproprietary Name or Common Name
Arsenic trioxide
Pharmaco-therapeutic Group
Other antioneoplastic agents
ATC Code
LO1XX27

Therapeutic Indication:
Trisenox is indicated for induction of remission and consolidation in adult patients with relapsed/refactory acute promyelocytic leukaemia (APL), characertised 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. Previous treatment should have included a retinoid and chemotherapy.

The response rate of other acute myelogenous leukaemia subtypes to Trisenox has not been examined.

Date of issue of Marketing Authorisation valid throughout the European Union
5 March 2002

Orphan medicinal product designation date
18 October 2000