EMEA-003573-PIP01-23 - paediatric investigation plan

pitavastatin (calcium)

ezetimibe

Key facts

• Active substance:
  • pitavastatin (calcium)
  • ezetimibe
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0143/2024
• PIP number:
  EMEA-003573-PIP01-23
• Pharmaceutical form(s):
  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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0143/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for pitavastatin calcium / ezetimibe, (EMEA-003573-PIP01- 23)

Adopted Reference Number: EMA/153124/2024