Sylvant

RSS

siltuximab

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Sylvant and why it is authorised in the EU

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 13/07/2018

Authorisation details

Product details
Name
Sylvant
Agency product number
EMEA/H/C/003708
Active substance
siltuximab
International non-proprietary name (INN) or common name
siltuximab
Therapeutic area (MeSH)
Giant Lymph Node Hyperplasia
Anatomical therapeutic chemical (ATC) code
L04AC11
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

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
Janssen-Cilag International NV
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
21/05/2014
Contact address
Turnhoutseweg 30
2340 Beerse
Belgium

Product information

12/04/2018 Sylvant - EMEA/H/C/003708 - II/0026/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Immunosuppresants
  • Interleukin inhibitors

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

How useful was this page?

Add your rating