EMEA-001911-PIP03-23-M01 - paediatric investigation plan

Inebilizumab

Key facts

• Invented name:
  Uplizna
• Active substance:
  Inebilizumab
• Therapeutic area:
  • Immune system disorders
  • Surgical and medical procedures
• Decision number:
  P/0217/2024
• PIP number:
  EMEA-001911-PIP03-23-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of immunoglobulin G4-related disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2024
• Compliance check done:
  No

Decision

P/0217/2024 : EMA decision of 13 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for inebilizumab (Uplizna) (EMEA-001911-PIP03-23-M01)

Adopted Reference Number: EMA/181396/2024