Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Skyrizi 150 mg solution for injection in pre-filled pen.
Skyrizi 150 mg solution for injection in pre-filled syringe.
Skyrizi 75 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
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Solution for injection (injection) Skyrizi 150 mg solution for injection in pre-filled pen and in pre-filled syringe: The solution is colourless to yellow and clear to slightly opalescent. Skyrizi 75 mg solution for injection in pre-filled syringe: The solution is colourless to slightly yellow and clear to slightly opalescent. |
Skyrizi 150 mg solution for injection in pre-filled pen: Each pre-filled pen contains 150 mg risankizumab in 1 mL solution.
Skyrizi 150 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 150 mg risankizumab in 1 mL solution.
Skyrizi 75 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 75 mg risankizumab in 0.83 mL solution.
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese Hamster Ovary cells using recombinant DNA technology.
Excipients with known effect (75 mg solution for injection only):
This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
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 |
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Skyrizi 150 mg solution for injection in pre-filled pen and pre-filled syringe: Sodium acetate trihydrate Skyrizi 75 mg solution for injection in pre-filled syringe: Disodium succinate hexahydrate |
Skyrizi 150 mg solution for injection in pre-filled pen:
Pre-filled glass syringe assembled in a pre-filled pen with an automatic needle sleeve.
Skyrizi 150 mg solution for injection in pre-filled syringe:
Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Skyrizi 150 mg is available in packs containing 1 pre-filled pen or 1 pre-filled syringe.
Skyrizi 75 mg solution for injection in pre-filled syringe:
Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Skyrizi 75 mg is available in packs containing 2 pre-filled syringes and 2 alcohol pads.
Not all presentations may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Skyrizi 150 mg solution for injection in pre-filled pen: EU/1/19/1361/002
Skyrizi 150 mg solution for injection in pre-filled syringe: EU/1/19/1361/003
Skyrizi 75 mg solution for injection in pre-filled syringe: EU/1/19/1361/001
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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