EMEA-002064-PIP01-16-M05 - paediatric investigation plan

Gilteritinib (as fumarate)

Key facts

• Invented name:
  Xospata
• Active Substance:
  Gilteritinib (as fumarate)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0267/2023
• PIP number:
  EMEA-002064-PIP01-16-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Astellas Pharma Europe B.V.; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023

Decision

P/0267/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for gilteritinib (as fumarate), (Xospata), (EMEA-002064-PIP01-16-M05)

Reference Number: EMA/250923/2023