BENLYSTA Solution for injection Ref.[6410] Active ingredients: Belimumab

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Benlysta 200 mg solution for injection in pre-filled pen.

Benlysta 200 mg solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection in pre-filled pen (injection).

Solution for injection in pre-filled syringe (injection).

A clear to opalescent, colourless to pale yellow solution, with a pH of 6.

Qualitative and quantitative composition

Pre-filled pen: Each 1-ml pre-filled pen contains 200 mg of belimumab.

Pre-filled syringe: Each 1-ml pre-filled syringe contains 200 mg of belimumab.

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

Arginine hydrochloride
Histidine
Histidine monohydrochloride
Polysorbate 80
Sodium chloride
Water for injections

Pack sizes and marketing

Pre-filled pen:

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.

Pre-filled syringe:

1 mL solution in a type 1 glass syringe with a fixed needle (stainless steel) and needle cap.

Available in pack of 1 pre-filled syringe and pack of 4 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

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)
EU/1/11/700/006 1 pre-filled syringe
EU/1/11/700/007 4 pre-filled syringes

Date of first authorisation: 13 July 2011
Date of latest renewal: 18 February 2016

Drugs

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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