EMEA-002141-PIP01-17-M04 - paediatric investigation plan

Crizanlizumab

Key facts

• Active Substance:
  Crizanlizumab
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0004/2024
• PIP number:
  EMEA-002141-PIP01-17-M04
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/01/2024

Decision

P/0004/2024 : EMA decision of 11 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan and on the granting of a product-specific waiver for crizanlizumab (EMEA-002141-PIP01-17-M04)

AdoptedReference Number: EMA/6414/2024