EMEA-001207-PIP02-19-M01 - paediatric investigation plan

obinutuzumab

Key facts

• Invented name:
  Gazyvaro
• Active substance:
  obinutuzumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0296/2022
• PIP number:
  EMEA-001207-PIP02-19-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022
• Compliance check done:
  Όχι

Decision

P/0296/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for obinutuzumab (Gazyvaro), (EMEA-001207-PIP02-19-M01)

Draft Reference Number: EMA/638317/2022