EMEA-000183-PIP02-12-M05 - paediatric investigation plan

apixaban

Key facts

• Invented name:
  Eliquis
• Active substance:
  apixaban
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0135/2024
• PIP number:
  EMEA-000183-PIP02-12-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral liquid dosage formulation
  • Age appropriate dosage form, other
• Condition(s) / indication(s):
  Treatment of venous thromboembolism
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/05/2024
• Compliance check done:
  Nej

Decision

P/0135/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis), (EMEA-000183-PIP02-12-M05)

Adopted Reference Number: EMA/153112/2024