BENLYSTA

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States

Active ingredients

The drug BENLYSTA contains one active pharmaceutical ingredient (API):

1 Belimumab UNII 73B0K5S26A - BELIMUMAB

Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B). Belimumab blocks the binding of soluble BLyS, a B cell survival factor, to its receptors on B cells. Belimumab by binding BLyS inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Read about Belimumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BENLYSTA Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC
BENLYSTA Powder for concentrate for solution for infusion / Solution for injection	FDA, National Drug Code (US)	MPI, US: SPL/PLR
BENLYSTA Powder for concentrate for solution for infusion	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L04AG04	Belimumab	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies
Discover more medicines within L04AG04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 510613030050002, 510613030050102, 510620100056007, 510620100056107
Country: CA	Health Products and Food Branch	Identifier(s): 02370050, 02370069, 02470489
Country: EE	Ravimiamet	Identifier(s): 1536960, 1536971, 1756267, 1756278, 1756289, 1756290, 1756302, 1831834, 1849563
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 111700004, 11700001, 11700002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 421527, 458249
Country: FR	Base de données publique des médicaments	Identifier(s): 60205159, 65592934, 65600733
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 194804, 194807, 391657
Country: HK	Department of Health Drug Office	Identifier(s): 61384, 61385, 66372
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6839, 6840, 8337
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999445D1020, 3999445D2027, 3999445G1027, 3999445G2023
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1061717, 1061718, 1084464, 1084465, 1084466, 1084467, 1084468, 1092971
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 149462, 98140, 98159
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 15758, 15759
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100250900, 100250917, 100395662
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65195001, W65197001
Country: SG	Health Sciences Authority	Identifier(s): 14211P, 14212P
Country: US	FDA, National Drug Code	Identifier(s): 49401-088, 49401-101, 49401-102