EMEA-001798-PIP02-16-M01 - paediatric investigation plan

Enasidenib

Key facts

• Active substance:
  Enasidenib
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0456/2022
• PIP number:
  EMEA-001798-PIP02-16-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0456/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for enasidenib (EMEA- 001798-PIP02-16-M01)

Adopted Reference Number: EMA/775977/2022