EMEA-002889-PIP02-20-M01 - paediatric investigation plan

ublituximab

Key facts

• Invented name:
  Briumvi
• Active substance:
  ublituximab
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0254/2024
• PIP number:
  EMEA-002889-PIP02-20-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/07/2024
• Compliance check done:
  Nej

Decision

P/0254/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ublituximab (Briumvi), (EMEA-002889-PIP02-20-M01)

Adopted Reference Number: EMA/296721/2024