EMEA-001214-PIP04-19-M01 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active substance:
  Benralizumab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0307/2024
• PIP number:
  EMEA-001214-PIP04-19-M01
• 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:
  16/08/2024
• Compliance check done:
  No

Decision

P/0307/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra), (EMEA-001214-PIP04-19-M01)

Adopted Reference Number: EMA/320727/2024