EMEA-003291-PIP01-22 - paediatric investigation plan

acetylsalicylic acid

rivaroxaban

Key facts

• Active substance:
  • acetylsalicylic acid
  • rivaroxaban
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0516/2022
• PIP number:
  EMEA-003291-PIP01-22
• 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:
  30/12/2022
• Compliance check done:
  No

Decision

P/0516/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for rivaroxaban / acetylsalicylic acid (EMEA-003291-PIP01- 22)

Adopted Reference Number: EMA/915657/2022