EMEA-000006-PIP03-12 - paediatric investigation plan

ezetimibe

simvastatin

Key facts

• Invented name:
  Inegy and associated names
• Active substance:
  • ezetimibe
  • simvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0141/2012
• PIP number:
  EMEA-000006-PIP03-12
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Prevention of coronary heart disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/07/2012
• Compliance check done:
  No

Decision

P/0141/2012: EMA decision of 23 July 2012 on the granting of a product specific waiver for ezetimibe / simvastatin (Inegy and associated names) (EMEA-000006-PIP03-12)

Adopted Reference Number: EMA/436977/2012