EMEA-001489-PIP01-13-M02 - paediatric investigation plan

Idasanutlin

Key facts

• Active substance:
  Idasanutlin
• Therapeutic area:
  Oncology
• Decision number:
  P/0081/2020
• PIP number:
  EMEA-001489-PIP01-13-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Film-coated dispersible tablet
• Condition(s) / indication(s):
  • Treatment of acute lymphoblastic leukaemia
  • 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:
  18/03/2020
• Compliance check done:
  No

Decision

P/0081/2020: EMA decision of 18 March 2020 on the acceptance of a modification of an agreed paediatric investigation plan for idasanutlin (EMEA-001489-PIP01-13-M02)

Adopted Reference Number: EMA/74170/2020