EMA/PE/0000244768 - paediatric investigation plan

darvadstrocel

Key facts

• Invented name:
  Alofisel
• Active substance:
  darvadstrocel
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  EMA/PE/0000244768
• PIP number:
  EMA/PE/0000244768
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of perianal fistula
• Route(s) of administration:
  Perilesional use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/05/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000244768 : EMA decision of 20 May 2025 on the acceptance of a modification of an agreed paediatric investigation plan for darvadstrocel (Alofisel)

Adopted Reference Number: EMADOC-1700519818-2145142