EMEA-002064-PIP01-16-M06 - paediatric investigation plan

Gilteritinib (as fumarate)

Key facts

• Invented name:
  Xospata
• Active substance:
  Gilteritinib (as fumarate)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0289/2024
• PIP number:
  EMEA-002064-PIP01-16-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral dosage formulation
• 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:
  16/08/2024
• Compliance check done:
  Non

Decision

P/0289/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gilteritinib (as fumarate) (Xospata), (EMEA-002064-PIP01-16-M06)

Adopted Reference Number: EMA/343426/2024