EMA/PE/0000241178 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active substance:
  Benralizumab
• Therapeutic area:
  • Immune system disorders
  • Pneumology-allergology
• Decision number:
  EMA/PE/0000241178
• PIP number:
  EMA/PE/0000241178
• 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:
  10/07/2025
• Compliance check done:
  Όχι

Decision

EMA/PE/0000241178 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra)

Adopted Reference Number: EMADOC-1700519818-2252168