EMEA-003438-PIP02-23 - paediatric investigation plan

obicetrapib

Key facts

• Active substance:
  obicetrapib
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0025/2024
• PIP number:
  EMEA-003438-PIP02-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of elevated cholesterol
• 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:
  31/01/2024
• Compliance check done:
  No

Decision

P/0025/2024 : EMA decision of 31 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obicetrapib, (EMEA-003438-PIP02-23)

Adopted Reference Number: EMA/25525/2024