EMEA-003562-PIP01-23 - paediatric investigation plan

ezetimibe

fenofibrate

rosuvastatin calcium

Key facts

• Active substance:
  • ezetimibe
  • fenofibrate
  • rosuvastatin calcium
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0161/2024
• PIP number:
  EMEA-003562-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0161/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for ezetimibe / fenofibrate / rosuvastatin calcium (EMEA- 003562-PIP01-23)

Adopted Reference Number: EMA/176534/2024