EMEA-000312-PIP01-08-M07 - paediatric investigation plan

Human coagulation factor VIII

von Willebrand factor

Key facts

• Invented name:
  • Voncento
  • Voncento
• Active Substance:
  • Human coagulation factor VIII
  • von Willebrand factor
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0274/2014
• PIP number:
  EMEA-000312-PIP01-08-M07
• Pharmaceutical form(s):
  • Powder and solvent for solution for injection
  • Powder and solvent for solution for infusion
• Condition(s) / indication(s):
  • Treatment of hereditary factor-VIII deficiency (Haemophilia A)
  • Treatment of von Willebrand disease
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  CSL Behring

  Germany; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2014
• Compliance procedure number:
  EMEA-C-000312-PIP01-08-M07
• Compliance opinion date:
  22/05/2015
• Compliance outcome:
  Positive

Decision

P/0274/2014: EMA decision of 28 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation Factor VIII / von Willebrand Factor (Voncento), (EMEA-000312-PIP01-08-M07)

Reference Number: EMA/605305/2014