MHRA-100140-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BENRALIZUMAB
Invented Name
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
PIP Number MHRA-100140-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection/infusion
Therapeutic area
Therapeutic area:
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
Conditions / Indications
Conditions / Indications:
  • Treatment of Hypereosinophilic syndrome (HES)
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
Yes
Compliance Check Decision Date
Compliance opinion date
06/02/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100140-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BENRALIZUMAB.pdf
Published Date 14/04/2026