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Marketing authorisation with orphan designation - USA

  • Tradename: DACOGEN
  • ATC code : -
  • EU Number: -
  • MA date : 02/05/2006
  • MA holder: EISAI INC.

Therapeutic indication

For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

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