EMEA-001489-PIP02-19 - paediatric investigation plan

Idasanutlin

Key facts

• Active substance:
  Idasanutlin
• Therapeutic area:
  Oncology
• Decision number:
  P/0196/2020
• PIP number:
  EMEA-001489-PIP02-19
• Pharmaceutical form(s):
  • Film-coated tablet
  • Film-coated dispersible tablet
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2020
• Compliance check done:
  No

Decision

P/0196/2020: EMA decision of 15 May 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for idasanutlin (EMEA-001489-PIP02-19)

Reference Number: EMA/240867/2020