EMA/PE/0000238109 - paediatric investigation plan

bempedoic acid (ETC-1002)

Key facts

• Invented name:
  Nilemdo
• Active substance:
  bempedoic acid (ETC-1002)
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  EMA/PE/0000238109
• PIP number:
  EMA/PE/0000238109
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
  • Age appropriate oral solid dosage form
• 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:
  12/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000238109 : EMA decision of 12 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for bempedoic acid (Nilemdo)

Adopted Reference Number: EMADOC-1700519818-2187668