Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Rystiggo 140 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless to pale brownish-yellow, clear to slightly opalescent solution, pH 5.6. Rystiggo has an osmolality of 309-371 mOsmol/kg. |
Each ml of solution for injection contains 140 mg of rozanolixizumab.
One vial of 2 ml contains 280 mg of rozanolixizumab.
Rozanolixizumab is a recombinant, humanised anti-neonatal Fc receptor (FcRn) immunoglobulin G 4P (IgG4P) monoclonal antibody produced in Chinese Hamster Ovary (CHO) by recombinant DNA technology.
Excipient(s) with known effect: Each ml of solution for injection contains 29 mg proline, see section 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rozanolixizumab |
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). |
| List of Excipients |
|---|
|
Histidine |
2 ml solution in a vial (Type I glass) with a stopper (rubber) sealed with a crimp seal and flip off cap.
Pack size of 1 vial.
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
EU/1/23/1780/001
| Drug | Countries | |
|---|---|---|
| RYSTIGGO | Austria, Estonia, France, Croatia, Lithuania, Romania, United States |
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