MHRA-100294-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • BENRALIZUMAB
Invented Name
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
PIP Number MHRA-100294-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection in pre-filled pen
  • Solution for injection in prefilled syringe
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of asthma
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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 29/07/2022