EMEA-003435-PIP02-23 - paediatric investigation plan

allogeneic faecal microbiota, pooled (MaaT013)

Key facts

• Active substance:
  allogeneic faecal microbiota, pooled (MaaT013)
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMEA-003435-PIP02-23
• PIP number:
  EMEA-003435-PIP02-23
• Pharmaceutical form(s):
  Rectal suspension
• Condition(s) / indication(s):
  Treatment of graft versus host disease
• Route(s) of administration:
  Rectal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/04/2025
• Compliance check done:
  Nee

Decision

EMEA-003435-PIP02-23 : EMA decision of 16 April 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for allogeneic faecal microbiota, pooled (MaaT013)

Adopted Reference Number: EMADOC-1700519818-2023857