Rozanolixizumab is a humanised IgG4 monoclonal antibody that decreases serum IgG concentration by inhibiting the binding of IgG to FcRn, a receptor that under physiological conditions protects IgG from intracellular degradation and recycles IgG back to the cell surface. By the same mechanism, rozanolixizumab decreases the concentration of pathogenic IgG autoantibodies associated with generalised myasthenia gravis (gMG).
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L04AG16 | L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies | |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| RYSTIGGO Solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR | |
| RYSTIGGO Solution for injection | European Medicines Agency (EU) | MPI, EU: SmPC |
Rozanolixizumab is an active ingredient of these brands:
United States (US)Austria (AT)Croatia (HR)Estonia (EE)France (FR)Lithuania (LT)Romania (RO)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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