MHRA-101323-PIP02-24

Key Facts

Active Substance
Active Substance:
  • tulisokibart
Invented Name
Not yet available
PIP Number MHRA-101323-PIP02-24
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for infusion
  • Age-appropriate dosage form for parenteral use
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of Crohn's disease
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
Yes
Compliance Check Decision Date
Compliance opinion date
06/10/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101323-PIP02-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):tulisokibart.pdf
Published Date 03/11/2026