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
The drug BENLYSTA contains one active pharmaceutical ingredient (API):
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1
Belimumab
UNII 73B0K5S26A - BELIMUMAB
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| BENLYSTA Powder for concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC | |
| BENLYSTA Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC | |
| Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
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 |
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 |
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