EMEA-002410-PIP01-18 - paediatric investigation plan

atorvastatin

ezetimibe

Key facts

• Active substance:
  • atorvastatin
  • ezetimibe
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0374/2018
• PIP number:
  EMEA-002410-PIP01-18
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  07/12/2018
• Compliance check done:
  No

Decision

P/0374/2018: EMA decision of 7 December 2018 on the granting of a product specific waiver for atorvastatin / ezetimibe (EMEA-002410-PIP01-18)

Adopted Reference Number: EMA/812161/2018