EMEA-001214-PIP07-21 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active substance:
  Benralizumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0038/2022
• PIP number:
  EMEA-001214-PIP07-21
• Pharmaceutical form(s):
  • Age appropriate dosage form for parenteral use
  • Solution for injection
  • Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of eosinophilic gastritis/eosinophilic gastroenteritis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022
• Compliance check done:
  Nee

Decision

P/0038/2022: EMA decision of 31 January 2022 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-PIP07-21)

Adopted Reference Number: EMA/12076/2022

Benralizumab (Fasenra) : notification of discontinuation of a paediatric development which is covered by an agreed PIP decision