EMEA-002933-PIP01-20 - paediatric investigation plan

Single strain of non-genetically modified Prevotella histicola (EDP1815)

Key facts

• Active Substance:
  Single strain of non-genetically modified Prevotella histicola (EDP1815)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0008/2022
• PIP number:
  EMEA-002933-PIP01-20
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of psoriasis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Evelo Biosciences, Inc.

  [e-mail]

  [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2022

Decision

P/0008/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for single strain of non-genetically modified Prevotella his... (EMEA- 002933-PIP01-20)

AdoptedReference Number: EMA/9458/2022