Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Tremfya 200 mg concentrate for solution for infusion.
| Pharmaceutical Form |
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Concentrate for solution for infusion. The solution is clear and colourless to light yellow, with target pH of 5.8 and approximate osmolarity of 302.7 mOsm/L. |
Each vial contains 200 mg of guselkumab in 20 mL solution (10 mg/mL). After dilution, each mL contains 0.8 mg of guselkumab.
Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Excipient(s) with known effect:
This medicinal product contains 10 mg of polysorbate 80 (E433) in each vial which is equivalent to 0.5 mg/mL.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 (IL-23) protein with high specificity and affinity. IL-23 is a cytokine that is involved in inflammatory and immune responses. By blocking IL-23 from binding to its receptor, guselkumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines. |
| List of Excipients |
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EDTA disodium dihydrate |
200 mg concentrate solution for infusion in a type I clear glass vial closed with a butyl rubber stopper, an aluminium seal and polypropylene flip top.
Tremfya is available in a 1 vial pack.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/17/1234/005
Date of first authorisation: 10 November 2017
Date of latest renewal:15 July 2022
| Drug | Countries | |
|---|---|---|
| TREMFYA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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