Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Spevigo 450 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to slightly brownish-yellow solution. |
Each vial contains 450 mg spesolimab in 7.5 mL.
Each mL of concentrate for solution for infusion contains 60 mg spesolimab.
After dilution, each mL of the solution contains 9 mg spesolimab (see section 6.6).
Spesolimab is produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Spesolimab |
Spesolimab is a humanised antagonistic monoclonal immunoglobulin G1 (IgG1) antibody blocking human interleukin 36 receptor (IL36R) signalling. Binding of spesolimab to IL36R prevents the subsequent activation of IL36R by its ligands (IL36 α, β and γ) and downstream activation of pro-inflammatory pathways. |
| List of Excipients |
|---|
|
Sodium acetate trihydrate (E262) |
7.5 mL concentrate in a colourless 10 mL glass vial (type I glass), with a coated rubber stopper and aluminium crimp cap with blue plastic button.
Pack size of 2 vials.
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
EU/1/22/1688/001
Date of first authorisation: 09 December 2022
Date of latest renewal: 15 September 2023
| Drug | Countries | |
|---|---|---|
| SPEVIGO | Austria, Estonia, Spain, France, Croatia, Italy, Japan, Lithuania, Romania, United States |
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