EMEA-003238-PIP02-22 - paediatric investigation plan

Pozelimab

Key facts

• Active Substance:
  Pozelimab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0464/2023
• PIP number:
  EMEA-003238-PIP02-22
• Pharmaceutical form(s):
  • Solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2023

Decision

P/0463/2023 : EMA decision of 1 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pozelimab (EMEA-003238-PIP02-22)

AdoptedReference Number: EMA/526347/2023