EMEA-003472-PIP01-23 - paediatric investigation plan

rosuvastatin

ezetimibe

Key facts

• Active substance:
  • rosuvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0490/2023
• PIP number:
  EMEA-003472-PIP01-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of cardiovascular events
  • 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:
  01/12/2023
• Compliance check done:
  No

Decision

P/0490/2023 : EMA decision of 1 December 2023 on the granting of a product specific waiver for rosuvastatin / ezetimibe (EMEA-003472-PIP01-23)

Adopted Reference Number: EMA/530028/2023