MHRA-101549-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Afimkibart
Invented Name
Not yet available
PIP Number MHRA-101549-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection/infusion
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of ulcerative colitis
Route(s) of administration
Route(s) of administration:
  • INTRAVENOUS USE SUBCUTANEOUS USE
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 07771398016
  • Email uk.dra@roche.com
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):Afimkibart.pdf
Published Date 11/09/2025