Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Benlysta 120 mg powder for concentrate for solution for infusion.
Benlysta 400 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to off-white powder. |
Benlysta 120 mg powder for concentrate for solution for infusion: Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per mL.
Benlysta 400 mg powder for concentrate for solution for infusion: Each vial contains 400 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per mL.
Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Citric acid monohydrate (E330) |
Benlysta 120 mg powder for concentrate for solution for infusion:
Type 1 glass vials (5 mL), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminium seal containing 120 mg of powder.
Pack size: 1 vial.
Benlysta 400 mg powder for concentrate for solution for infusion:
Type 1 glass vials (20 mL), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminium seal containing 400 mg of powder.
Pack size: 1 vial.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/11/700/001 1 vial – 120 mg
EU/1/11/700/002 1 vial – 400 mg
Date of first authorisation: 13 July 2011
Date of latest renewal: 18 February 2016
| Drug | Countries | |
|---|---|---|
| BENLYSTA | 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 |
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