SKYRIZI Solution for injection Ref.[8750] Active ingredients: Risankizumab

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany

Product name and form

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

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.

Qualitative and quantitative composition

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 selective to the interleukin (IL)-23 protein 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 and inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines. Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis.

List of Excipients

Skyrizi 150 mg solution for injection in pre-filled pen and pre-filled syringe:

Sodium acetate trihydrate
Acetic acid
Trehalose dihydrate
Polysorbate 20
Water for injections

Skyrizi 75 mg solution for injection in pre-filled syringe:

Disodium succinate hexahydrate
Succinic acid
Sorbitol
Polysorbate 20
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany

Marketing authorization dates and numbers

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

Drugs

Drug Countries
SKYRIZI Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom

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