EMEA-003514-PIP01-23 - paediatric investigation plan

obicetrapib

ezetimibe

Key facts

• Active substance:
  • obicetrapib
  • ezetimibe
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0017/2024
• PIP number:
  EMEA-003514-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of mixed hyperlipidaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2024
• Compliance check done:
  No

Decision

P/0017/2024 : EMA decision of 31 January 2024 on the granting of a product-specific waiver for obicetrapib / ezetimibe (EMEA-003514-PIP01-23)

Adopted Reference Number: EMA/15349/2024