EMEA-001207-PIP06-22 - paediatric investigation plan

Obinutuzumab

Key facts

• Invented name:
  Gazyvaro
• Active Substance:
  Obinutuzumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0502/2022
• PIP number:
  EMEA-001207-PIP06-22
• Pharmaceutical form(s):
  Concentrate and solvent for concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

P/0502/2022 : EMA decision of 1 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obinutuzumab (Gazyvaro), (EMEA-001207-PIP06-22)

Reference Number: EMA/901090/2022