EMEA-001214-PIP08-21 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active substance:
  Benralizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0497/2021
• PIP number:
  EMEA-001214-PIP08-21
• Pharmaceutical form(s):
  • Age appropriate dosage form for parenteral use
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of non-cystic fibrosis bronchiectasis with an eosinophilic phenotype
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/12/2021
• Compliance check done:
  No

Decision

P/0497/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for benralizumab (Fasenra), (EMEA-001214-PIP08-21)

Adopted Reference Number: EMA/622955/2021