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Marketing authorization with orphan designation - USA

  • Tradename: TRISENOX
  • ATC code : L01XX27
  • EU Number: -
  • MA date : 25/09/2000
  • MA holder: CEPHALON, INC.

Therapeutic indication

* In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
* For induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation of PML/RAR-alpha gene expression.

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