Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Tremfya 100 mg solution for injection in pre-filled syringe.
Tremfya 100 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
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Solution for injection (injection). The solution is clear and colourless to light yellow. |
Tremfya 100 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 100 mg of guselkumab in 1 mL solution.
Tremfya 100 mg solution for injection in pre-filled pen: Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.
Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Guselkumab |
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, a regulatory cytokine, affects the differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease. In humans, selective blockade of IL-23 was shown to normalize production of these cytokines. |
| List of Excipients |
|---|
|
Histidine |
Tremfya 100 mg solution for injection in pre-filled syringe: 1 mL solution in a pre-filled glass syringe with a fixed needle and a needle shield, assembled in an automatic needle guard.
Tremfya is available in a pack containing one pre-filled syringe and in a multipack containing 2 (2 packs of 1) pre-filled syringes. Not all pack sizes may be marketed.
Tremfya 100 mg solution for injection in pre-filled pen: 1 mL solution in a pre-filled glass syringe assembled in a pre-filled pen with an automatic needle guard.
Tremfya is available in a pack containing one pre-filled pen and in a multipack containing 2 (2 packs of 1) pre-filled pens.
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/1/17/1234/002 1 pre-filled pen
EU/1/17/1234/003 2 pre-filled pens
EU/1/17/1234/004 2 pre-filled syringes
Date of first authorisation: 10 November 2017
| Drug | Countries | |
|---|---|---|
| TREMFYA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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