EMEA-001872-PIP01-15-M02 - paediatric investigation plan

Bempedoic acid (ETC-1002)

Key facts

• Active Substance:
  Bempedoic acid (ETC-1002)
• Therapeutic area:
  • Cardiovascular diseases
  • Other
• Decision number:
  P/0351/2022
• PIP number:
  EMEA-001872-PIP01-15-M02
• Pharmaceutical form(s):
  Age-appropriate oral liquid dosage form
• Condition(s) / indication(s):
  Treatment of elevated cholesterol
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Esperion Therapeutics, Inc.

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2022

Decision

P/0351/2022: EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bempedoic acid (Nilemdo), (EMEA-001872-PIP01-15-M02)

Reference Number: EMA/631062/2022