EMEA-000063-PIP01-07-M01 - paediatric investigation plan

nicotinic acid

laropiprant

Key facts

• Invented name:
  • Tredaptive
  • Tredaptive
• Active Substance:
  • nicotinic acid
  • laropiprant
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0262/2012
• PIP number:
  EMEA-000063-PIP01-07-M01
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Modified-release tablet
• Condition(s) / indication(s):
  • Prevention of major vascular and major coronary events
  • Treatment of dyslipidaemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp and Dohme (Europe), Inc.

  Belgium; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/11/2012

Decision

P/0262/2012: EMA decision of of 20 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for nicotinic acid / laropiprant (Tredaptive), (EMEA-000063-PIP01-07-M01)

AdoptedReference Number: EMA/646946/2012