Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Benlysta 200 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
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Solution for injection in pre-filled pen (injection). A clear to opalescent, colourless to pale yellow solution, with a pH of 6 and an osmolality of 270–320 mOsm/kg. |
Each 1 mL pre-filled pen contains 200 mg of belimumab.
Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology.
Excipient with known effect:
Each pre-filled pen contains 0.1 mg polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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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. |
| List of Excipients |
|---|
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Arginine hydrochloride |
1 mL solution in a type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Available in packs of 1 or 4 pre-filled pens and multipack containing 12 single-dose pre-filled pens (3 packs of 4 pre-filled pens).
Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/11/700/003 1 pre-filled pen
EU/1/11/700/004 4 pre-filled pens
EU/1/11/700/005 12 (3x4) pre-filled pens (multipack)
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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