EMEA-000310-PIP03-10-M06 - paediatric investigation plan

ocrelizumab

Key facts

• Invented name:
  Ocrevus
• Active Substance:
  ocrelizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0424/2022
• PIP number:
  EMEA-000310-PIP03-10-M06
• 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:
  28/10/2022

Decision

P/0424/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ocrelizumab (Ocrevus), (EMEA-000310-PIP03-10-M06)

AdoptedReference Number: EMA/825317/2022