EMEA-003144-PIP01-21 - paediatric investigation plan

asundexian

Key facts

• Active substance:
  asundexian
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0021/2023
• PIP number:
  EMEA-003144-PIP01-21
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2023
• Compliance check done:
  No

Decision

P/0021/2023: EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for asundexian (EMEA-003144-PIP01-21)

Reference Number: EMA/20377/2023