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 formulation
• Condition(s) / indication(s):
  Treatment of elevated cholesterol
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2022
• Compliance check done:
  No

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