EMEA-002054-PIP01-16-M03 - paediatric investigation plan

Odevixibat

Key facts

• Invented name:
  Bylvay
• Active Substance:
  Odevixibat
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0147/2022
• PIP number:
  EMEA-002054-PIP01-16-M03
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of Progressive Familial Intrahepatic Cholestasis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022

Decision

P/0147/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for odevixibat (Bylvay), (EMEA-002054-PIP01-16-M03)

AdoptedReference Number: EMA/206556/2022