Is Siltuximab approved by the US FDA?

Drugs@FDA lists 1 application product line for Siltuximab, including SYLVANT (Prescription).

Is Siltuximab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Siltuximab: Sylvant.

Are there safety signals or safety updates for Siltuximab?

US FDA: 1 entry (latest 2019-12-05).

Active substance

Siltuximab

US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SYLVANT	100MG; 400MG	injectable · injection	RECORDATI RARE DISEASES, INC.	Prescription	23 Apr 2014

EMA European Union — centrally authorised medicines

Sylvant Recordati Netherlands B.V. · Authorised · authorised 22 May 2014 · ATC L04AC11

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SYLVANT	02435128	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	RECORDATI RARE DISEASES CANADA INC
SYLVANT	02435136	400 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	RECORDATI RARE DISEASES CANADA INC

Safety signals and safety-related labeling changes

US FDA 5 Dec 2019 SYLVANT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for siltuximab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.