EMEA-003205-PIP01-22 - paediatric investigation plan

atorvastatin

ezetimibe

Key facts

• Active substance:
  • atorvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0272/2022
• PIP number:
  EMEA-003205-PIP01-22
• 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:
  10/08/2023
• Compliance check done:
  No

Decision

P/0272/2022 : EMA decision on 10 August 2022 on the granting of a product specific waiver for atorvastatin / ezetimibe (EMEA-003205-PIP01-22)

Adopted Reference Number: EMA/659386/2022