MHRA-100376-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • VEDOLIZUMAB
Invented Name
  • Entyvio
  • Entyvio
  • Entyvio
  • Entyvio
PIP Number MHRA-100376-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Powder for concentrate for solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
  • Treatment of Crohn's disease
  • Treatment of Ulcerative colitis
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
PIP applicant
  • Takeda Pharma A/S, Dybendall Alle 10, 2630 Taastrup, Denmark
  • Country Denmark
  • Tel 02031168000
  • Email paediatrics@tgrd.com
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 22/12/2022