Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Skyrizi 360 mg solution for injection in cartridge.
Skyrizi 180 mg solution for injection in cartridge.
Skyrizi 90 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
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Solution for injection (injection). Skyrizi 180 mg and 360 mg solution for injection in cartridge: The solution is colourless to yellow and clear to slightly opalescent. Skyrizi 90 mg solution for injection in pre-filled syringe: The solution is colourless to slightly yellow and clear to slightly opalescent. |
Skyrizi 360 mg solution for injection in cartridge: Each cartridge contains 360 mg of risankizumab in 2.4 mL solution.
Skyrizi 180 mg solution for injection in cartridge: Each cartridge contains 180 mg of risankizumab in 1.2 mL solution.
Skyrizi 90 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 90 mg of risankizumab in 1 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 (90 mg solution for injection only): This medicinal product contains 164 mg sorbitol per 360 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 180 mg and 360 mg solution for injection in cartridge: Sodium acetate trihydrate Skyrizi 90 mg solution for injection in pre-filled syringe: Disodium succinate hexahydrate |
Skyrizi 360 mg solution for injection in cartridge:
A 360 mg solution in a single use cartridge made with cyclic olefin resin with coated chlorobutyl rubber septum and coated chlorobutyl rubber piston as product-contact materials, and a resin cap. The cartridge assembly is co-packed with an on-body injector (administration device). The fluid path within the on-body injector contains polyvinyl chloride tubing and a stainless steel 29-gauge needle. The on-body injector contains silver oxide-zinc batteries and an adhesive skin patch made from polyester with an acrylic adhesive. The administration device is designed for use with the provided 360 mg cartridge.
Skyrizi 360 mg is available in packs containing 1 cartridge and 1 on-body injector.
Skyrizi 180 mg solution for injection in cartridge:
A 180 mg solution in a single use cartridge made with cyclic olefin resin with coated chlorobutyl rubber septum and coated chlorobutyl rubber piston as product-contact materials, and a resin cap. The cartridge assembly is co-packed with an on-body injector (administration device). The fluid path within the on-body injector contains polyvinyl chloride tubing and a stainless steel 29-gauge needle. The on-body injector contains silver oxide-zinc batteries and an adhesive skin patch made from polyester with an acrylic adhesive. The administration device is designed for use with the provided 180 mg cartridge.
Skyrizi 180 mg is available in packs containing 1 cartridge and 1 on-body injector.
Skyrizi 90 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 90 mg is available in packs containing 4 pre-filled syringes.
Not all presentations may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Skyrizi 360 mg solution for injection in cartridge: EU/1/19/1361/005
Skyrizi 180 mg solution for injection in cartridge: EU/1/19/1361/007
Skyrizi 90 mg solution for injection in pre-filled syringe: EU/1/19/1361/006
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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