EMEA-000006-PIP02-10 - paediatric investigation plan

Ezetimibe

simvastatin

Key facts

• Invented name:
  Inegy and associated names
• Active Substance:
  • Ezetimibe
  • simvastatin
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/95/2011
• PIP number:
  EMEA-000006-PIP02-10
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular events in chronic kidney 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:
  04/04/2011

Decision

P/95/2011: EMA decision of 4 April 2011 on the granting of a product specific waiver for ezetimibe/simvastatin (Inegy and associated names) (EMEA-000006-PIP02-10)

AdoptedReference Number: EMA/247674/2011