EMEA-001911-PIP03-23 - paediatric investigation plan

Inebilizumab

Key facts

• Invented name:
  Uplizna
• Active Substance:
  Inebilizumab
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0531/2023
• PIP number:
  EMEA-001911-PIP03-23
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/12/2023

Decision

P/0531/2023: EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for inebilizumab (Uplizna), (EMEA-001911-PIP03-23)

Reference Number: EMA/514061/2023