EMEA-000189-PIP01-08 - paediatric investigation plan

Pegylated recombinant factor VIIa

Key facts

• Active Substance:
  Pegylated recombinant factor VIIa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/28/2009
• PIP number:
  EMEA-000189-PIP01-08
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Hereditary factor VIII and factor IX deficiency
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Contact for public enquiries:

  Novo Nordisk A/S

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/02/2009

Decision

P/28/2009: European Medicines Agency decision of 23 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for pegylated recombinant Factor VII...

AdoptedReference Number: EMEA/90244/2009