EMEA-001214-PIP05-19 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active substance:
  Benralizumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0388/2021
• PIP number:
  EMEA-001214-PIP05-19
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for injection/infusion
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of eosinophilic esophagitis
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/09/2021
• Compliance check done:
  Ne

Decision

P/0388/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benralizumab (Fasenra) (EMEA-001214-PIP05-19)

Adopted Reference Number: EMA/418670/2021