Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: STADA Arzneimittel AG, Stadastrasse 2â18, 61118 Bad Vilbel, Germany
Uzpruvo 45 mg solution for injection in pre-filled syringe.
Uzpruvo 90 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear and colourless to slightly yellow and practically free of visible particles. |
Uzpruvo 45 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
Uzpruvo 90 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 90 mg ustekinumab in 1 mL.
Ustekinumab is a fully human IgG1Îș monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ustekinumab |
Ustekinumab is a fully human IgG1Îș monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells. Abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. |
| List of Excipients |
|---|
|
Histidine |
Uzpruvo 45 mg solution for injection in pre-filled syringe: 0.5 mL solution for injection in a pre-filled type I glass 1 mL syringe with a fixed 29-gauge, extended finger flanges and passive safety needle device, and a plunger stopper (bromobutyl rubber), plunger rod and rigid needle shield (RNS).
Uzpruvo 90 mg solution for injection in pre-filled syringe: 1 mL solution for injection in a pre-filled syringe type I glass 1 mL syringe with a fixed 29-gauge needle, extended finger flanges and passive needle, safety device and a plunger stopper (bromobutyl rubber), plunger rod and rigid needle shield (RNS).
Uzpruvo is available in a pack of 1 pre-filled syringe.
STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany
Uzpruvo 45 mg solution for injection in pre-filled syringe: EU/1/23/1784/001
Uzpruvo 90 mg solution for injection in pre-filled syringe: EU/1/23/1784/004
| Drug | Countries | |
|---|---|---|
| UZPRUVO | Austria, Estonia, France, Croatia, Lithuania, Romania |
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