EMEA-002649-PIP02-20 - paediatric investigation plan

Ezetimibe

atorvastatin

Key facts

• Active Substance:
  • Ezetimibe
  • atorvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0215/2020
• PIP number:
  EMEA-002649-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:
  16/06/2020

Decision

P/0215/2020: EMA decision of 16 June 2020 on the granting of a product specific waiver for ezetimibe / atorvastatin (EMEA-002649-PIP02-20)

AdoptedReference Number: EMA/288454/2020