EMEA-000254-PIP01-08 - paediatric investigation plan

nicotinic acid

simvastatin

laropiprant

Key facts

• Active Substance:
  • nicotinic acid
  • simvastatin
  • laropiprant
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/72/2008
• PIP number:
  EMEA-000254-PIP01-08
• Pharmaceutical form(s):
  Modified-release tablet
• Condition(s) / indication(s):
  Hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/08/2008

Decision

P/72/2008: European medicines agency decision of 20 August 2008 on the application for agreement of a Paediatric Investigation Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000254-PIP01-08), in accordance w...

AdoptedReference Number: EMEA/431920/2008