MHRA-100184-PIP01-21

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • BENRALIZUMAB
Invented Name
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
PIP Number MHRA-100184-PIP01-21
Pharmaceutical form(s)
  • Solution for injection
  • Age-appropriate dosage form for parenteral use
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BENRALIZUMAB.pdf
Published Date 17/05/2022