EMA/PE/0000228360 - paediatric investigation plan

ezetimibe

rosuvastatin

Key facts

• Active substance:
  • ezetimibe
  • rosuvastatin
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  EMA/PE/0000228360
• PIP number:
  EMA/PE/0000228360
• 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:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000228360 : EMA decision of 28 January 2025 on the granting of a product specific waiver for ezetimibe / rosuvastatin

Adopted Reference Number: EMADOC-1700519818-1856165