EMA/PE/0000238005 - paediatric investigation plan

inebilizumab

Key facts

• Invented name:
  Uplizna
• Active substance:
  inebilizumab
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000238005
• PIP number:
  EMA/PE/0000238005
• 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:
  27/11/2024
• Compliance check done:
  No

Decision

EMA/PE/0000238005: EMA decision of 27 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for inebilizumab (Uplinza)

Adopted Reference Number: EMADOC-1700519818-1776292