Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
BimzelBimzelx 160 mg solution for injection in pre-filled syringe.
Bimzelx 320 mg solution for injection in pre-filled syringe.
Bimzelx 160 mg solution for injection in pre-filled pen.
Bimzelx 320 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear to slightly opalescent and, colourless to pale brownish-yellow. |
Bimzelx 160 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 160 mg of bimekizumab in 1 mL.
Bimzelx 320 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 320 mg of bimekizumab in 2 mL.
Bimzelx 160 mg solution for injection in pre-filled pen: Each pre-filled pen contains 160 mg of bimekizumab in 1 mL.
Bimzelx 320 mg solution for injection in pre-filled pen: Each pre-filled pen contains 320 mg of bimekizumab in 2 mL.
Bimekizumab is a humanised IgG1monoclonal antibody produced in a genetically engineered Chinese hamster ovary (CHO) cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Bimekizumab is a humanised IgG1/κ monoclonal antibody that selectively binds with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. Elevated concentrations of IL-17A and IL-17F have been implicated in the pathogenesis of several immune-mediated inflammatory diseases including plaque psoriasis. |
| List of Excipients |
|---|
|
Glycine |
Bimzelx 160 mg solution for injection in pre-filled syringe:
One mL pre-filled syringe (Type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a rigid needle shield (consisting of a thermoplastic elastomer needle cover and a polypropylene rigid shield) assembled in an automatic needle guard.
Pack size of 1 pre-filled syringe.
Pack size of 2 pre-filled syringes.
Multipack containing 3 (3 packs of 1) pre-filled syringes.
Multipack containing 4 (2 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.
Bimzelx 320 mg solution for injection in pre-filled syringe:
Two mL pre-filled syringe (Type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a rigid needle shield (consisting of a thermoplastic elastomer needle cover and a polypropylene rigid shield) assembled in an automatic needle guard.
Pack size of 1 pre-filled syringe.
Multipack containing 3 (3 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Bimzelx 160 mg solution for injection in pre-filled pen:
One mL pre-filled pen containing a pre-filled syringe (Type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a rigid needle shield consisting of a thermoplastic elastomer needle cover and a polypropylene rigid shield.
Pack size of 1 pre-filled pen.
Pack size of 2 pre-filled pens.
Multipack containing 3 (3 packs of 1) pre-filled pens.
Multipack containing 4 (2 packs of 2) pre-filled pens.
Not all pack sizes may be marketed.
Bimzelx 320 mg solution for injection in pre-filled pen:
Two mL pre-filled pen containing a pre-filled syringe (Type I glass) with a fluoropolymer-laminated bromobutyl rubber stopper, staked 27G, ½" thin wall needle, and a rigid needle shield consisting of a thermoplastic elastomer needle cover and a polypropylene rigid shield.
Pack size of 1 pre-filled pen.
Multipack containing 3 (3 packs of 1) pre-filled pens.
Not all pack sizes may be marketed.
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Bimzelx 160 mg solution for injection in pre-filled syringe:
EU/1/21/1575/001
EU/1/21/1575/002
EU/1/21/1575/003
EU/1/21/1575/004
Bimzelx 320 mg solution for injection in pre-filled syringe:
EU/1/21/1575/009
EU/1/21/1575/010
Bimzelx 160 mg solution for injection in pre-filled pen:
EU/1/21/1575/005
EU/1/21/1575/006
EU/1/21/1575/007
EU/1/21/1575/008
Bimzelx 320 mg solution for injection in pre-filled pen:
EU/1/21/1575/011
EU/1/21/1575/012
Date of first authorisation: 20 August 2021
| Drug | Countries | |
|---|---|---|
| BIMZELX | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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