Pravastatin sodium / Fenofibrate - paediatric investigation plan

Pravastatin sodium

fenofibrate

Key facts

• Active substance:
  • Pravastatin sodium
  • fenofibrate
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/115/2009
• PIP number:
  Pravastatin sodium / Fenofibrate
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Disorders of lipoprotein metabolism and other hyperlipidaemias
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/06/2009
• Compliance check done:
  No

Decision

P/115/2009: European Medicines Agency decision of 15 June 2009 on the granting of a product specific waiver for Pravastatin sodium / Fenofibrate (EMEA-000501-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of t...

Adopted Reference Number: EMEA/351862/2009