MHRA-101256-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RISANKIZUMAB
Invented Name
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
PIP Number MHRA-101256-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
  • Age-appropriate dosage form for parenteral use
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of ulcerative colitis
Route(s) of administration
  • Intravenous use
  • SUBCUTANEOUS USE
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):RISANKIZUMAB.pdf
Published Date 15/08/2024