EMA/PE/0000238977 - paediatric investigation plan

eubacterial spores, purified from allogeneic faecal donations

Key facts

• Active substance:
  eubacterial spores, purified from allogeneic faecal donations
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0390/2018
• PIP number:
  EMA/PE/0000238977
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of Clostridium difficile infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000238977: EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for Eubacterial spores, purified from allogeneic faecal donations

Adopted Reference Number: EMADOC-1700519818-2039230