Simvastatin / fenofibrate - paediatric investigation plan

simvastatin

fenofibrate

Key facts

• Active substance:
  • simvastatin
  • fenofibrate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/92/2009
• PIP number:
  Simvastatin / fenofibrate
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Combined dyslipidemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/05/2009
• Compliance check done:
  No

Decision

P/92/2009: European medicines agency decision of 18 May 2009 on the granting of a product specific waiver for simvastatin / fenofibrate (EMEA-000490-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Europe...

Adopted Reference Number: EMEA/280391/2009