EMEA-000185-PIP01-08-M05 - paediatric investigation plan

catridecacog

Key facts

• Invented name:
  • NovoThirteen
  • NovoThirteen
• Active Substance:
  catridecacog
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0001/2013
• PIP number:
  EMEA-000185-PIP01-08-M05
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of congenital factor-XIII A-subunit deficiency
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Novo Nordisk A/S

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/01/2013
• Compliance procedure number:
  EMEA-C-000185-PIP01-08-M05
• Compliance opinion date:
  16/12/2016
• Compliance outcome:
  Positive

Decision

P/0001/2013: EMA decision of 11 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for catridecacog (NovoThirteen) (EMEA-000185-PIP01-08-M05)

AdoptedReference Number: EMA/826252/2012