MHRA-100511-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • GUSELKUMAB
Invented Name
TREMFYA
PIP Number MHRA-100511-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Solution for injection in pre-filled pen
  • Solution for injection in pre-filled syringe
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of Crohn's disease
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):GUSELKUMAB.pdf
Published Date 07/12/2022