EMEA-001911-PIP01-15-M05 - paediatric investigation plan

Inebilizumab

Key facts

• Invented name:
  Uplizna
• Active Substance:
  Inebilizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0513/2023
• PIP number:
  EMEA-001911-PIP01-15-M05
• Pharmaceutical form(s):
  • Solution for infusion
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of neuromyelitis optica spectrum disorders
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/12/2023

Decision

P/0513/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for inebilizumab (EMEA-001911-PIP01-15-M05)

Reference Number: EMA/554681/2023