EMA/PE/0000235658 - paediatric investigation plan

asundexian

Key facts

• Active substance:
  asundexian
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  EMA/PE/0000235658
• PIP number:
  EMA/PE/0000235658
• Pharmaceutical form(s):
  • Age appropriate oral dosage formulation
  • Film-coated tablet
• Condition(s) / indication(s):
  Prevention of arterial thromboembolism
• Route(s) of administration:
  • Gastric use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000235658 : EMA decision of 16 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for asundexian

Adopted Reference Number: EMADOC-1700519818-2037714