EMA/PE/0000228536 - paediatric investigation plan

enlicitide (decanoate)

Key facts

• Active substance:
  enlicitide (decanoate)
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0133/2024
• PIP number:
  EMA/PE/0000228536
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate formulation
• Condition(s) / indication(s):
  Treatment of hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000228536: EMA decision of 19 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for enlicitide (decanoate)

Adopted Reference Number: EMADOC-1700519818-1976306