EMEA-000574-PIP02-12-M04 - paediatric investigation plan

blinatumomab

Key facts

• Invented name:
  Blincyto
• Active substance:
  blinatumomab
• Therapeutic area:
  Oncology
• Decision number:
  P/0449/2023
• PIP number:
  EMEA-000574-PIP02-12-M04
• 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:
  Yes
• Compliance procedure number:
  EMEA-C-000574-PIP02-12-M04
• Compliance opinion date:
  23/02/2024
• Compliance outcome:
  Positive

Decision

P/0449/2023: EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for blinatumomab (Blincyto) (EMEA-000574-PIP02-12-M04)

Reference Number: EMA/480376/2023