MHRA-100625-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RISANKIZUMAB
Invented Name
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
PIP Number MHRA-100625-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
  • Age appropriate dosage form for parenteral use
Therapeutic area
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of psoriasis
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
12/02/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100625-PIP01-22-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RISANKIZUMAB.pdf
Published Date 15/07/2026