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Marketing authorisation with orphan designation - Europe

  • Tradename: DACOGEN
  • ATC code : L01BC08
  • EU Number: EMEA/H/C/2221/IB/26
  • MA date : 30/06/2016
  • MA holder: JANSSEN-CILAG INTERNATIONAL NV
  • European Public Assessment Report

Therapeutic indication

Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

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