EMEA-002852-PIP01-20 - paediatric investigation plan

atorvastatin

ezetimibe

Key facts

• Active substance:
  • atorvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0445/2020
• PIP number:
  EMEA-002852-PIP01-20
• 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:
  04/12/2020
• Compliance check done:
  No

Decision

P/0445/2020 : EMA decision of 4 December 2020 on the granting of a product specific waiver for atorvastatin / ezetimibe (EMEA-002852-PIP01-20)

Adopted Reference Number: EMA/622704/2020