MHRA-100361-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • GOLIMUMAB
Invented Name
  • Simponi 50 mg solution for injection in pre-filled pen
  • Simponi 50 mg solution for injection in pre-filled syringe
  • Simponi 100 mg solution for injection in pre-filled pen
  • Simponi 45 mg/0.45 mL solution for injection in pre-filled pen
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
  • Simponi
PIP Number MHRA-100361-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of ulcerative colitis
Route(s) of administration
Route(s) of administration:
  • 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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

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