MHRA-100283-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • USTEKINUMAB
Invented Name
  • Stelara
  • Stelara
PIP Number MHRA-100283-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion Solution for injection
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of Crohn's disease
Route(s) of administration
Route(s) of administration:
  • SUBCUTANEOUS USE INTRAVENOUS 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
12/02/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100283-PIP01-21-M03-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):USTEKINUMAB.pdf
Published Date 14/04/2026