EMEA-003390-PIP01-23 - paediatric investigation plan

pitavastatin

ezetimibe

Key facts

• Active Substance:
  • pitavastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0185/2023
• PIP number:
  EMEA-003390-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2023

Decision

P/0185/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for pitavastatin / ezetimibe (EMEA-003390-PIP01-23)

Reference Number: EMA/176289/2023