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BENLYSTA Solution for injection (2019)

Active ingredients: Belimumab

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.

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

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
Authorization dates

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

Date of first authorisation: 13 July 2011

Date of latest renewal: 18 February 2016

Marketing authorization number:

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