Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sylvant   
Auth. number : EU/1/14/928
Active substance : siltuximab
Orphan market exclusivity for "Treatment of Castlemanís disease" (based on designation EU/3/07/508) started on 27/05/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/05/2024
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC11 - Siltuximab
(See WHO ATC Index)
Indication: Sylvant is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus 8 (HHV 8) negative.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/05/2014 Centralised - Authorisation EMEA/H/C/3708 (2014)3557 of 22/05/2014
10/07/2014 Centralised - Variation EMEA/H/C/3708/IB/1
Updated with Decision(2015)5157 of 17/07/2015
26/02/2015 Centralised - Variation EMEA/H/C/3708/IA/5
Updated with Decision(2015)5157 of 17/07/2015
13/03/2015 Centralised - Notification EMEA/H/C/3708/N/7
Updated with Decision(2015)5157 of 17/07/2015
03/06/2015 Centralised - Variation EMEA/H/C/3708/IB/8
Updated with Decision(2015)5157 of 17/07/2015
22/07/2015 Centralised - Yearly update (2015)5157 of 17/07/2015
03/05/2016 Centralised - Variation EMEA/H/C/3708/IB/0012
Updated with Decision(2017)3557 of 11/04/2017
13/01/2017 Centralised - Variation EMEA/H/C/003708/IB/0018
Updated with Decision(2017)3557 of 11/04/2017
03/02/2017 Centralised - Variation EMEA/H/C/003708/IA/0020/G
Updated with Decision(2017)3557 of 11/04/2017
13/04/2017 Centralised - Yearly update (2017)3557 of 11/04/2017
17/05/2017 Centralised - Variation EMEA/H/C/003708/IB/0022