Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Tremfya 100 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
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Solution for injection (injection). The solution is clear and colourless to light yellow and may contain a few small white or clear particles, with target pH of 5.8 and approximate osmolarity of 367.5 mOsm/L. |
Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.
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 0.5 mg of polysorbate 80 (E433) in each pre-filled syringe 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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Histidine |
1 mL solution in a pre-filled glass syringe with a bromobutyl rubber stopper, a fixed needle and a needle shield, assembled in an automatic needle guard.
Tremfya is available in packs containing one pre-filled syringe and in multipacks containing 2 (2 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/17/1234/001 1 pre-filled syringe
EU/1/17/1234/004 2 pre-filled syringes
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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