EMEA-000971-PIP01-10-M03 - paediatric investigation plan

human coagulation factor X

Key facts

• Invented name:
  • Coagadex
  • Coagadex
• Active substance:
  human coagulation factor X
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0389/2017
• PIP number:
  EMEA-000971-PIP01-10-M03
• Pharmaceutical form(s):
  Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of hereditary factor X deficiency
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/12/2017
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000971-PIP01-10-M03
• Compliance opinion date:
  26/01/2018
• Compliance outcome:
  Positive

Decision

P/0389/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation factor X (Coagadex), (EMEA-000971-PIP01-10-M03)

Adopted Reference Number: EMA/797364/2017