This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 12/05/2021

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Giant Lymph Node Hyperplasia
Anatomical therapeutic chemical (ATC) code
Accelerated assessmentAccelerated assessment

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.

Publication details
Marketing-authorisation holder
EUSA Pharma (Netherlands) BV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Beechavenue 54
1119PW Schiphol-Rijk
The Netherlands

Product information

09/04/2021 Sylvant - EMEA/H/C/003708 - IAIN/0035


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Pharmacotherapeutic group


Therapeutic 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.

Assessment history

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