EMEA-001207-PIP01-11-M01 - paediatric investigation plan

obinutuzumab

Key facts

• Invented name:
  Gazyvaro
• Active substance:
  obinutuzumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0196/2021
• PIP number:
  EMEA-001207-PIP01-11-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of mature B-cell lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/05/2021
• Compliance check done:
  Ne

Decision

P/0196/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for obinutuzumab (Gazyvaro), (EMEA-001207-PIP01-11-M01)

Adopted Reference Number: EMA/249298/2021