Ezetimibe and simvastatin (fixed combination) - paediatric investigation plan

ezetimibe

simvastatin

Key facts

• Invented name:
  INEGY and associated trade names
• Active substance:
  • ezetimibe
  • simvastatin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/73/2008
• PIP number:
  Ezetimibe and simvastatin (fixed combination)
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Hypercholesterolaemia
  • Mixed (combined) hyperlipidaemia
  • Sitosterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/09/2008
• Compliance check done:
  No

Decision

P/73/2008: European medicines agency decision of 14 September 2008 on the application for agreement of a Paediatric Investigation Plan for[d2] ezetimibe and simvastatin (fixed combination) (INEGY and associated trade na...

Adopted Reference Number: EMEA/467238/2008