EMA/PE/0000257216 - paediatric investigation plan

bempedoic acid

ezetimibe

atorvastatin

Key facts

• Active substance:
  • bempedoic acid
  • ezetimibe
  • atorvastatin
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  EMA/PE/0000257216
• PIP number:
  EMA/PE/0000257216
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of elevated cholesterol
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/07/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000257216 : EMA decision of 10 July 2025 on the granting of a product specific waiver for bempedoic acid / ezetimibe / atorvastatin

Adopted Reference Number: EMADOC-1700519818-2252182