EMEA-001438-PIP01-13-M01 - paediatric investigation plan

idarucizumab

Key facts

• Invented name:
  • Praxbind
  • Praxbind
• Active substance:
  idarucizumab
• Therapeutic area:
  Other
• Decision number:
  P/0151/2019
• PIP number:
  EMEA-001438-PIP01-13-M01
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  • Prevention of dabigatran associated haemorrhage
  • Treatment of dabigatran associated haemorrhage
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2019
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001438-PIP01-13-M01
• Compliance opinion date:
  24/07/2020
• Compliance outcome:
  Positive

Decision

P/0151/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for idarucizumab (Praxbind), (EMEA-001438-PIP01-13-M01)

Adopted Reference Number: EMA/215040/2019