EMA/PE/0000253868 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active substance:
  Benralizumab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000253868
• PIP number:
  EMA/PE/0000253868
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of hypereosinophilic syndrome
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/07/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000240204 : EMA decision of 11 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra)

Adopted Reference Number: EMADOC-1700519818-2256465