Source: European Medicines Agency (EU) Revision Year: 2026 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 33.2 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 |
|---|
|
L-histidine |
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
EU/1/22/1674/001
Date of first authorisation: 10 August 2022
| Drug | Countries | |
|---|---|---|
| VYVGART | Austria, France, Croatia, Israel, Italy, Japan, Lithuania, Romania, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.