MHRA-101808-PIP01-25-M01 (update)

Key Facts

Active Substance
Active Substance:
  • DARVADSTROCEL
Invented Name
Alofisel
PIP Number MHRA-101808-PIP01-25-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for injection
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of perianal fistula
Route(s) of administration
Route(s) of administration:
  • INTRALESIONAL USE
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):DARVADSTROCEL.pdf
Published Date 11/09/2025