Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: argenx BV, Industriepark-Zwijnaarde 7, 9052 Gent, Belgium
Vyvgart 1 000 mg solution for injection.
| Pharmaceutical Form |
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Solution for injection. Yellowish, clear to opalescent, pH 6.0. |
Each vial contains 1 000 mg of efgartigimod alfa in 5.6 mL (180 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.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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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 |
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Recombinant human hyaluronidase (rHuPH20) |
5.6 mL solution in a 6 mL Type I glass vial with rubber stopper, aluminium seal and polypropylene flip-off cap.
Pack size of 1 vial.
argenx BV, Industriepark-Zwijnaarde 7, 9052 Gent, Belgium
EU/1/22/1674/002
Date of first authorisation: 10 August 2022
| Drug | Countries | |
|---|---|---|
| VYVGART | Austria, France, Croatia, Israel, Italy, Japan, Lithuania, Romania, United States |
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