EMEA-002631-PIP01-19-M02 - paediatric investigation plan

Key facts

• Therapeutic area:
  Oncology
• Decision number:
  P/0253/2023
• PIP number:
  EMEA-002631-PIP01-19-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute myeloid leukaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/07/2023

Decision

P/0253/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed PIP for (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]...

Reference Number: EMA/303523/2023