EMA/PE/0000240317 - paediatric investigation plan

odevixibat sesquihydrate

Key facts

• Invented name:
  Bylvay
• Active substance:
  odevixibat sesquihydrate
• Therapeutic area:
  • Hepatobiliary disorders
  • Gastroentology-Hepatology
• Decision number:
  EMA/PE/0000240317
• PIP number:
  EMA/PE/0000240317
• Pharmaceutical form(s):
  • Age appropriate oral liquid dosage formulation
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of biliary atresia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/07/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000240317 : EMA decision of 10 July 2025 on the acceptance of a modification of an agreed paediatric investigation plan for odevixibat sesquihydrate (Bylvay)

Adopted Reference Number: EMADOC-1700519818-2257381