EMEA-001821-PIP01-15-M08 - paediatric investigation plan

Quizartinib

Key facts

• Invented name:
  Vanflyta
• Active Substance:
  Quizartinib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0203/2024
• PIP number:
  EMEA-001821-PIP01-15-M08
• 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024

Decision

P/0203/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for quizartinib (Vanflyta) (EMEA-001821-PIP01-15-M08)

Adopted