MHRA-100057-PIP01-21

Key Facts

Active Substance
Active Substance:
  • BENRALIZUMAB
Invented Name
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
PIP Number MHRA-100057-PIP01-21
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection /infusion
  • Age-appropriate dosage form for parenteral use
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of eosinophilic oesophagitis
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BENRALIZUMAB.pdf
Published Date 17/03/2022