MHRA-100068-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • VEDOLIZUMAB
Invented Name
  • Entyvio
  • Entyvio
PIP Number MHRA-100068-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion Solution for injection
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of Pouchitis
Route(s) of administration
Route(s) of administration:
  • INTRAVENOUS USE 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

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):VEDOLIZUMAB.pdf
Published Date 25/05/2023