EMEA-001834-PIP02-16-M01 - paediatric investigation plan

Betrixaban

Key facts

• Invented name:
  Dexxience
• Active substance:
  Betrixaban
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0168/2018
• PIP number:
  EMEA-001834-PIP02-16-M01
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Prevention of venous thromboembolism
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  18/06/2018
• Compliance check done:
  Nej

Decision

P/0168/2018: EMA decision of 18 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for betrixaban (EMEA-001834-PIP02-16-M01)

Adopted Reference Number: EMA/381968/2018