EMEA-000430-PIP01-08-M11 - paediatric investigation plan

rivaroxaban

Key facts

• Invented name:
  Xarelto
• Active substance:
  rivaroxaban
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0126/2019
• PIP number:
  EMEA-000430-PIP01-08-M11
• Pharmaceutical form(s):
  • Oral suspension
  • Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of thromboembolic events
  • Treatment of thromboembolic events
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2019
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-000430-PIP01-08-M11
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0126/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban (Xarelto), (EMEA-000430-PIP01-08-M11)

Adopted Reference Number: EMA/215013/2019