EMEA-003373-PIP01-22 - paediatric investigation plan

atorvastatin

ezetimibe

Key facts

• Active substance:
  • atorvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0158/2023
• PIP number:
  EMEA-003373-PIP01-22
• 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:
  12/05/2023
• Compliance check done:
  No

Decision

P/0158/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for atorvastatin / ezetimibe (EMEA-003373-PIP01-22)

Reference Number: EMA/170258/2023