EMEA-001561-PIP01-13-M02 - paediatric investigation plan

darvadstrocel

Key facts

• Invented name:
  Alofisel
• Active substance:
  darvadstrocel
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0026/2021
• PIP number:
  EMEA-001561-PIP01-13-M02
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of perianal fistula
• Route(s) of administration:
  Other use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/01/2021
• Compliance check done:
  No

Decision

P/0026/2021: EMA decision of 27 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for darvadstrocel (Alofisel) (EMEA-001561-PIP01-13-M02)

Adopted Reference Number: EMA/33469/2021