EMEA-001207-PIP05-22 - paediatric investigation plan

Obinutuzumab

Key facts

• Invented name:
  Gazyvaro
• Active substance:
  Obinutuzumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0345/2023
• PIP number:
  EMEA-001207-PIP05-22
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of glomerulonephritis and nephrotic syndrome
• 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 date:
  08/09/2023

Decision

P/0345/2023 : EMA decision of 8 September 2023 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-PIP05-22)

Reference Number: EMA/351993/2023