Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
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. |
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 |
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.
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)
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
| 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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
