EMEA-001821-PIP01-15-M06 - paediatric investigation plan

Quizartinib

Key facts

• Active Substance:
  Quizartinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0091/2023
• PIP number:
  EMEA-001821-PIP01-15-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral solution
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Daiichi Sankyo Europe GmbH

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0091/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for quizartinib (EMEA- 001821-PIP01-15-M06)

Reference Number: EMA/73601/2023