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Sylvant is a medicine that is used to treat multicentric Castleman’s disease in adults who are not infected with human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8).
Castleman’s disease is a disorder of the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream) in which cells in lymph nodes start growing abnormally, causing benign tumours. Multicentric means that the disease affects several lymph nodes as well as other organs in the body. Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.
Castleman’s disease is rare, and Sylvant was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 November 2007.
Sylvant contains the active substance siltuximab.
Sylvant : EPAR - Summary for the public (PDF/109.24 KB)
First published: 19/06/2014
Last updated: 13/07/2018
Sylvant : EPAR - Risk-management-plan summary (PDF/71.17 KB)
First published: 19/06/2014
Last updated: 19/06/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Giant Lymph Node Hyperplasia
|Anatomical therapeutic chemical (ATC) code||
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
EUSA Pharma (Netherlands) BV
|Date of issue of marketing authorisation valid throughout the European Union||
08/02/2023 Sylvant - EMEA/H/C/003708 - IB/0039
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.
European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 201410/07/2014