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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Chimeric-anti-interleukin-6 monoclonal antibody

EU orphan designation number: EU/3/07/508   
Active ingredient: Chimeric-anti-interleukin-6 monoclonal antibody
Indication: Treatment of Castleman’s disease
Sponsor: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Sylvant on 22/05/2014 with the number EU/1/14/928

   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
4/12/2007 Orphan designation EMEA/OD/078/07 (2007)6048 of 30/11/2007
24/08/2011 Change of name and/or address of sponsor EMEA/OD/078/07
11/06/2013 Transfer of orphan designation EMEA/OD/078/07/T/01 (2013)3673 of 7/06/2013
9/04/2014 Other procedure