MHRA-100286-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • USTEKINUMAB
Invented Name
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • STELARA
  • Stelara
  • STELARA
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
PIP Number MHRA-100286-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of ulcerative colitis
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
Yes
Compliance Check Decision Date
Compliance opinion date
25/02/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100286-PIP01-21-M02 -C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):USTEKINUMAB.pdf
Published Date 10/04/2026