EMEA-000788-PIP02-11-M11 - paediatric investigation plan

edoxaban tosilate

Key facts

• Invented name:
  Lixiana
• Active substance:
  edoxaban tosilate
• Therapeutic area:
  • Cardiovascular diseases
  • Haematology-Hemostaseology
• Decision number:
  P/0423/2021
• PIP number:
  EMEA-000788-PIP02-11-M11
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral dosage formulation
• Condition(s) / indication(s):
  • Prevention of arterial thromboembolism
  • Prevention of venous thromboembolism
  • 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:
  29/10/2021
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000788-PIP02-11-M11
• Compliance opinion date:
  11/11/2022
• Compliance outcome:
  Positive

Decision

P/0423/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for edoxaban (tosylate) (Lixiana), (EMEA-000788-PIP02-11-M11)

Adopted Reference Number: P/0423/2021