EMEA-001429-PIP01-13-M07 - paediatric investigation plan

Inotuzumab ozogamicin

Key facts

• Invented name:
  Besponsa
• Active substance:
  Inotuzumab ozogamicin
• Therapeutic area:
  • Haematology-Hemostaseology
  • Oncology
• Decision number:
  P/0079/2023
• PIP number:
  EMEA-001429-PIP01-13-M07
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of B cell acute lymphoblastic leukaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023
• Compliance check done:
  Nie

Decision

P/0079/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for inotuzumab ozogamicin (Besponsa), (EMEA-001429-PIP01-13-M07)

Adopted Reference Number: EMA/74598/2023