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Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion (2012)

Active ingredients: Belimumab

Product Name and Form

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.

Qualitative and Quantitative Composition

Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ml.

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.

Chemical substance
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)
Sodium citrate (E331)
Sucrose
Polysorbate 80

Pack sizes and Marketing

120 mg vial: Type 1 glass vials (5 ml), sealed with a latex-free, siliconised chlorobutyl rubber stopper and a flip-off aluminum seal.

400 mg vial: Type 1 glass vials (20 ml), sealed with a latex-free, siliconised chlorobutyl rubber stopper and a flip-off aluminum seal.

Pack size: 1 vial.

Marketing authorization holder
Authorization dates

Glaxo Group Limited
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Date of first authorisation: 13 July 2011

Marketing authorization number:

Benlysta 120 mg – Powder for concentrate for solution for infusion: EU/1/11/700/001

Benlysta 400 mg – Powder for concentrate for solution for infusion: EU/1/11/700/002