EMEA-000060-PIP01-07-M03

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 Tel. +41 613241111 E-mail: paediatric.enquiries@novartis.com
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

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