Vanflyta

quizartinib

Opinion

The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).

The Agency issued its opinion on 17 October 2019. The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.

Key facts

Name
Vanflyta
Agency product number
EMEA/H/C/004468
International non-proprietary name (INN) or common name
  • quizartinib
Active substance
  • quizartinib dihydrochloride
Therapeutic area
Leukemia, Myeloid, Acute
Date opinion adopted
17/10/2019
Company name
Daiichi Sankyo Europe GmbH
Status
Negative
Application type
Initial authorisation

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