EMEA-000778-PIP02-12-M01 - paediatric investigation plan

Vorapaxar

Key facts

• Active Substance:
  Vorapaxar
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0131/2016
• PIP number:
  EMEA-000778-PIP02-12-M01
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Prevention of arterial thromboembolism
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

  Tel. [phone]; Email: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  20/05/2016

Decision

P/0131/2016: EMA decision of 20 May 2016on the acceptance of a modification of an agreed paediatric investigation plan for vorapaxar (EMEA-000778-PIP02-12-M01)

AdoptedReference Number: EMA/269206/2016