EMEA-000060-PIP01-07-M03

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)
  • Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)
  • Muckle-Wells Syndrome (MWS),
  • Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU)
  • Cryopyrin Associated Periodic Syndromes (CAPS)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Novartis Europharm Limited
Switzerland
E-mail: paediatric.enquiries@novartis.com
Tel. +41 613241111
Fax: +41 613248001
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000060-PIP01-07-M03
Compliance opinion date
19/06/2015
Compliance outcome
positive

Decision

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