EMEA-002247-PIP03-17-M01 - paediatric investigation plan

Ivosidenib

Key facts

• Active substance:
  Ivosidenib
• Therapeutic area:
  Oncology
• Decision number:
  P/0001/2024
• PIP number:
  EMEA-002247-PIP03-17-M01
• Pharmaceutical form(s):
  Film-coated tablet
• 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:
  03/01/2024
• Compliance check done:
  Non

Decision

P/0001/2024 : EMA decision of 3 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ivosidenib (Tibsovo), (EMEA-002247-PIP03-17-M01)

Adopted Reference Number: EMA/931/2024