EMEA-002202-PIP02-20 - paediatric investigation plan

rosuvastatin

ezetimibe

Key facts

• Active substance:
  • rosuvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0251/2020
• PIP number:
  EMEA-002202-PIP02-20
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/07/2020
• Compliance check done:
  No

Decision

P/0251/2020 : EMA decision of 15 July 2020 on the granting of a product specific waiver for rosuvastatin / ezetimibe (Coroswera) (EMEA-002202-PIP02-20)

Adopted Reference Number: EMA/316712/2020