EMEA-002819-PIP01-20-M01 - paediatric investigation plan

Magrolimab

Key facts

• Active substance:
  Magrolimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0263/2023
• PIP number:
  EMEA-002819-PIP01-20-M01
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  • Treatment of acute myeloid leukaemia
  • Treatment of myelodysplastic syndromes, including juvenile myelomonocytic leukemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0263/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for magrolimab (EMEA- 002819-PIP01-20-M01)

Reference Number: EMA/285601/2023