Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Skyrizi 600 mg concentrate for solution for infusion.
| Pharmaceutical Form |
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Concentrate for solution for infusion (sterile concentrate). The solution is colourless to slightly yellow and clear to slightly opalescent. |
Each vial contains 600 mg of risankizumab in 10.0 mL of solution.
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese Hamster Ovary cells using recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Risankizumab |
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine without binding to IL-12 and inhibits its interaction with the IL-23 receptor complex. IL-23 is a cytokine that is involved in inflammatory and immune responses. By blocking IL-23 from binding to its receptor, risankizumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate |
10.0 mL concentrate solution for infusion in a glass vial closed with a coated bromobutyl rubber stopper.
Skyrizi is available in packs containing 1 vial pack.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
EU/1/19/1361/004
Date of first authorisation: 26 April 2019
Date of latest renewal: 5 January 2024
| Drug | Countries | |
|---|---|---|
| SKYRIZI | Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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