EMEA-003591-PIP01-24 - paediatric investigation plan

fenofibrate

rosuvastatin calcium

Key facts

• Active substance:
  • fenofibrate
  • rosuvastatin calcium
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0200/2024
• PIP number:
  EMEA-003591-PIP01-24
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of elevated cholesterol with elevated triglycerides
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2024
• Compliance check done:
  No

Decision

P/0200/2024: EMA decision of 14 June 2024 on the granting of a product specific waiver for fenofibrate / rosuvastatin calcium (EMEA-003591- PIP01-24)

Adopted Reference Number: P/0200/2024