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Pharmaceuticals - Community Register

  

Community list of not active orphan medicinal products


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Product information

Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class

EU orphan designation number: EU/3/07/439
Active ingredient: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Indication: Treatment of cryopirin-associated periodic syndromes (Familial Cold Urticaria Syndrome (FCUS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem Inflammatory Disease (NOMID), also known as Chronic Infantile Neurological Cutaneous
Sponsor: Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ilaris on 23/10/2009 with the number EU/1/09/564

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/03/2007 Orphan Designation EMEA/OD/071/06 (2007)1329 of 20/03/2007
02/12/2010 Removal of orphan designation from Community Register