EMEA-001970-PIP02-17 - paediatric investigation plan

SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated)

Key facts

• Active substance:
  SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0390/2018
• PIP number:
  EMEA-001970-PIP02-17
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of Clostridium difficile infection
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  07/12/2018
• Compliance check done:
  No

Decision

P/0390/2018: EMA decision of 7 December 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated) (EMEA- 001970-PIP02-17)

Adopted Reference Number: EMA/789884/2018