EMA/PE/0000237224 - paediatric investigation plan

ocrelizumab

Key facts

• Invented name:
  Ocrevus
• Active substance:
  ocrelizumab
• Therapeutic area:
  Neurology
• Decision number:
  EMA/PE/0000237224
• PIP number:
  EMA/PE/0000237224
• 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:
  14/04/2025
• Compliance check done:
  Non

Decision

EMA/PE/0000237224 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ocrelizumab (Ocrevus)

Adopted Reference Number: EMADOC-1700519818-2037817