EMEA-001214-PIP09-21-M01 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active substance:
  Benralizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0173/2023
• PIP number:
  EMEA-001214-PIP09-21-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of eosinophilic granulomatosis with polyangiitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/05/2023
• Compliance check done:
  Nej

Decision

P/0173/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra), (EMEA-001214-PIP09-21-M01)

Adopted Reference Number: EMA/171103/2023