EMEA-003438-PIP01-23 - paediatric investigation plan

obicetrapib

Key facts

• Active substance:
  obicetrapib
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0375/2023
• PIP number:
  EMEA-003438-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of mixed dyslipidaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2023
• Compliance check done:
  No

Decision

P/0375/2023: EMA decision of 8 September 2023 on the granting of a product specific waiver for obicetrapib (EMEA-003438-PIP01-23)

Adopted Reference Number: EMA/351240/2023