Source: European Medicines Agency (EU) Revision Year: 2024 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 |
|---|
|
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) 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 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 |
|---|
|
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, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
