EMEA-002054-PIP03-20-M02 - paediatric investigation plan

odevixibat

Key facts

• Active substance:
  odevixibat
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0515/2022
• PIP number:
  EMEA-002054-PIP03-20-M02
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral liquid dosage formulation
• Condition(s) / indication(s):
  Treatment of Alagille syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/12/2022
• Compliance check done:
  Nein

Decision

P/0515/2022 : EMA decision of 6 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for odevixibat (Bylvay), (EMEA-002054-PIP03-20-M02)

Adopted Reference Number: EMA/912385/2022