Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
STELARA 45 mg solution for injection.
STELARA 45 mg solution for injection in pre-filled syringe.
STELARA 90 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
STELARA 45 mg solution for injection: Solution for injection. STELARA 45 mg solution for injection in pre-filled syringe: Solution for injection. STELARA 90 mg solution for injection in pre-filled syringe: Solution for injection. The solution is clear to slightly opalescent, colourless to light yellow. |
STELARA 45 mg solution for injection: Each vial contains 45 mg ustekinumab in 0.5 mL.
STELARA 45 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
STELARA 90 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.
Ustekinumab is a fully human IgG1Îș monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ustekinumab |
Ustekinumab is a fully human IgG1Îș monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells. Abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. |
| List of Excipients |
|---|
|
L-histidine |
STELARA 45 mg solution for injection: 0.5 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper.
STELARA 45 mg solution for injection in pre-filled syringe: 0.5 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover containing dry natural rubber (a derivative of latex). The syringe is fitted with a passive safety guard.
STELARA 90 mg solution for injection in pre-filled syringe: 1 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover containing dry natural rubber (a derivative of latex). The syringe is fitted with a passive safety guard.
STELARA is available in a 1 vial pack or a pack of 1 pre-filled syringe.
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
STELARA 45 mg solution for injection: EU/1/08/494/001
STELARA 45 mg solution for injection in pre-filled syringe: EU/1/08/494/003
STELARA 90 mg solution for injection in pre-filled syringe: EU/1/08/494/004
Date of first authorisation: 16 January 2009
Date of latest renewal: 19 September 2013
| Drug | Countries | |
|---|---|---|
| STELARA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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