BENLYSTA

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

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 more about Belimumab

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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