EMEA-003453-PIP01-23 - paediatric investigation plan

enlicitide (decanoate)

Key facts

• Active Substance:
  enlicitide (decanoate)
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0133/2024
• PIP number:
  EMEA-003453-PIP01-23
• Pharmaceutical form(s):
  • Age-appropriate formulation
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  04/12/2024

Decision

P/0133/2024: EMA decision of 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for enlicitide (decanoate) (EMEA-003453-PIP01-23)

AdoptedReference Number: EMA/144124/2024