Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
STELARA 130 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. The solution is clear, colourless to light yellow. |
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/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 |
|---|
|
EDTA disodium salt dihydrate |
26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper. STELARA is available in a 1 vial pack.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/08/494/005
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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