EMEA-002064-PIP01-16-M03 - paediatric investigation plan

Gilteritinib (as fumarate)

Key facts

• Invented name:
  Xospata
• Active Substance:
  Gilteritinib (as fumarate)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0110/2021
• PIP number:
  EMEA-002064-PIP01-16-M03
• Pharmaceutical form(s):
  • Capsule (hard)
  • 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:
  17/03/2021

Decision

P/0110/2021: EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for gilteritinib (as fumarate) (Xospata), (EMEA-002064-PIP01-16-M03)

AdoptedReference Number: EMA/144934/2021