MHRA-101723-PIP01-24-M01 (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
  • Selara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
PIP Number MHRA-101723-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis).
Route(s) of administration
  • intravenous
  • 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
02/09/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101723-PIP01-24-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):USTEKINUMAB.pdf
Published Date 14/10/2026