EMEA-002247-PIP02-17 - paediatric investigation plan

Ivosidenib

Key facts

• Active substance:
  Ivosidenib
• Therapeutic area:
  Oncology
• Decision number:
  P/0406/2019
• PIP number:
  EMEA-002247-PIP02-17
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
• Route(s) of administration:
  • Oral use
  • Naso-gastric use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  04/12/2019
• Compliance check done:
  No

Decision

P/0406/2019: EMA decision of 4 December 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for ivosidenib (EMEA-002247-PIP02-17)

Adopted Reference Number: EMA/593200/2019