EMEA-001806-PIP04-19-M02 - paediatric investigation plan

carfilzomib

Key facts

• Invented name:
  Kyprolis
• Active substance:
  carfilzomib
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0408/2023
• PIP number:
  EMEA-001806-PIP04-19-M02
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of acute lymphoblastic leukaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2023
• Compliance check done:
  Nem

Decision

P/0408/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for carfilzomib (Kyprolis), (EMEA-001806-PIP04-19-M02)

Adopted Reference Number: EMA/429693/2023