MHRA-100068-PIP01-21

Key Facts

Active Substance
Active Substance:
  • VEDOLIZUMAB
Invented Name
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio; Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
  • Kynteles
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
PIP Number MHRA-100068-PIP01-21
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
  • Intravenous use
  • 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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100068-PIP01-21-C1

Decision Document

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