EMEA-000060-PIP01-07-M03 - paediatric investigation plan

canakinumab

Key facts

• Invented name:
  Ilaris
• Active substance:
  canakinumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/208/2011
• PIP number:
  EMEA-000060-PIP01-07-M03
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Powder and solvent for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  • Cryopyrin Associated Periodic Syndromes (CAPS)
  • Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU)
  • Muckle-Wells Syndrome (MWS)
  • Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/09/2011
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000060-PIP01-07-M03
• Compliance opinion date:
  19/06/2015
• Compliance outcome:
  Positive

Decision

P/208/2011: EMA decision of 2 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (EMEA- 000060-PIP01-07-M03)

Adopted Reference Number: EMA/644005/2011