Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: argenx BV, Industriepark-Zwijnaarde 7, 9052 Gent, Belgium
Vyvgart 20 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Colourless to slightly yellow, clear to slightly opalescent, pH 6.7. |
Each vial of 20 mL contains 400 mg of efgartigimod alfa (20 mg/mL).
Efgartigimod alfa is a human recombinant immunoglobulin G1 (IgG1)-derived Fc fragment produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Excipient(s) with known effect: Each vial contains 67.2 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Efgartigimod alfa |
Efgartigimod alfa is a human IgG1 antibody fragment engineered for increased affinity to the neonatal Fc Receptor (FcRn). Efgartigimod alfa binds to FcRn, resulting in a reduction in the levels of circulating IgG including pathogenic IgG autoantibodies. Efgartigimod alfa does not affect the levels of other immunoglobulins (IgA, IgD, IgE or IgM), or those of albumin. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate, monohydrate |
Concentrate in single-dose 20 mL glass vials (Type I) with rubber stopper (butyl, siliconised), aluminium seal and polypropylene flip-off cap.
Pack size of 1 vial.
argenx BV, Industriepark-Zwijnaarde 7, 9052 Gent, Belgium
Date of first authorisation: 10 August 2022
| Drug | Countries | |
|---|---|---|
| VYVGART | Israel, Japan, Lithuania, Romania, United States |
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