EMEA-001573-PIP03-23 - paediatric investigation plan

Pemafibrate

Key facts

• Active substance:
  Pemafibrate
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0350/2023
• PIP number:
  EMEA-001573-PIP03-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of primary biliary cholangitis
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0350/2023 : EMA decision of 8 September 2023 on the granting of a product specific waiver for pemafibrate (EMEA-001573-PIP03-23)

Reference Number: EMA/380487/2023