EMEA-000310-PIP05-22 - paediatric investigation plan

ocrelizumab

Key facts

• Invented name:
  Ocrevus
• Active Substance:
  ocrelizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0191/2023
• PIP number:
  EMEA-000310-PIP05-22
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  26/05/2023

Decision

P/0191/2023: EMA decision of 26 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ocrelizumab (Ocrevus), (EMEA-000310-PIP05-22)

Reference Number: EMA/184305/2023