Benlysta 200 MG Solucion Inyectable en Pluma PrecargadaSpain · 200 mg · solución inyectable en pluma precargada · Glaxosmithkline (Ireland) Limited

BENLYSTA 400 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONSpain · 400 mg · polvo para concentrado para solución para perfusión · Glaxosmithkline (Ireland) Limited

BenlystaEuropean Union · GlaxoSmithKline Trading Services Limited

BenlystaCroatia

BenlystaItaly · Soluzione iniettabile · Glaxosmithkline (Ireland) Limited

BenlystaRomania · 120 mg · pulb. pt. conc. pt. sol. perf. · Glaxosmithkline (Ireland) Limited

BENLYSTA 120mgRomania · 120mg · pulb. pt. conc. pt. sol. perf. · Glaxo Group Limited

BENLYSTA 400mgRomania · 400mg · pulb. pt. conc. pt. sol. perf. · Glaxo Group Limited

Benlysta 120MG Powder for Solution for InfusionSaudi Arabia · Hospira

Benlysta 400MG Powder for Solution for InfusionSaudi Arabia · Hospira

BenlystaSaudi Arabia · Glaxo Operations UK Ltd

Benlysta Powder for Solution for Infusion 120mgSingapore · 120mg/vial · injection, powder, lyophilized, for solution · Glaxosmithkline Pte LTD

Benlysta Powder for Solution for Infusion 400mgSingapore · 400mg/vial · injection, powder, lyophilized, for solution · Glaxosmithkline Pte LTD

BenlystaUnited States · 120MG, 200MG/ML, 400MG · injectable · Human Genome Sciences INC.

BenlystaUnited States · 200MG/ML · Injection · GlaxoSmithKline LLC

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Belimumab
Dosage form: Poeder voor oplossing voor infusie
Route: Intraveneus gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 13 Jul 2011
Registration: EU/1/11/700
Marketing authorisation holder: GlaxoSmithKline (Ireland) Ltd.
ATC code: L04AG04
Group: Antineoplastic and immunomodulating agents
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/002015
EU number: EU/1/11/700

Netherlands

Benlysta 400 mg, Poeder voor oplossing voor infusieBelimumab · Poeder voor oplossing voor infusieNetherlands