EMEA-003635-PIP01-24 - paediatric investigation plan

heterologous intestinal microbiota from healthy donors (MBK-01)

Key facts

• Active substance:
  heterologous intestinal microbiota from healthy donors (MBK-01)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0003/2025
• PIP number:
  EMEA-003635-PIP01-24
• Pharmaceutical form(s):
  Gastro-resistant capsule (hard)
• Condition(s) / indication(s):
  Treatment of Clostridioides difficile infection (CDI)
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/01/2025
• Compliance check done:
  No

Decision

P/0003/2025 : EMA decision of 28 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for heterologous intestinal microbiota from healthy donors (MBK-01), (EMEA-003635-PIP01-24)

Adopted Reference Number: EMA/9335/2025