EMA/PE/0000238858 - paediatric investigation plan

acetylsalicylic acid

rivaroxaban

Key facts

• Active substance:
  • acetylsalicylic acid
  • rivaroxaban
• Therapeutic area:
  Vascular disorders
• Decision number:
  EMA/PE/0000238858
• PIP number:
  EMA/PE/0000238858
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Prevention of atherothrombotic events
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/04/2025
• Compliance check done:
  Nei

Decision

EMA/PE/0000238858 : EMA decision of 16 April 2025 on the granting of a product specific waiver for acetylsalicylic acid, rivaroxaban

Adopted Reference Number: EMADOC-1700519818-2008689