EMEA-001024-PIP01-10-M02 - paediatric investigation plan

Human-cell-line recombinant human factor VIII (human-cl rhFVIII)

human Coagulation Factor VIII (rDNA)

Key facts

• Invented name:
  Nuwiq and associated names
• Active substance:
  • Human-cell-line recombinant human factor VIII (human-cl rhFVIII)
  • human Coagulation Factor VIII (rDNA)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0014/2020
• PIP number:
  EMEA-001024-PIP01-10-M02
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of haemophilia A (congenital factor-VIII deficiency)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/01/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001024-PIP01-10-M02
• Compliance opinion date:
  26/03/2021
• Compliance outcome:
  Positive

Decision

P/0014/2020: EMA decision of 6 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for Human Cell Line recombinant human Factor VIII (human-cl rhFVIII) / Human Coagulation Factor VIII (rDNA)

Adopted Reference Number: EMA/658950/2019