VYVGART Concentrate for solution for infusion Ref.[50188] Active ingredients: Efgartigimod alfa

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: argenx BV, Industriepark-Zwijnaarde 7, 9052 Gent, Belgium

Product name and form

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.

Qualitative and quantitative composition

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
Disodium hydrogen phosphate, anhydrous
Sodium chloride
Arginine hydrochloride
Polysorbate 80
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

argenx BV, Industriepark-Zwijnaarde 7, 9052 Gent, Belgium

Marketing authorization dates and numbers

Date of first authorisation: 10 August 2022

Drugs

Drug Countries
VYVGART Austria, France, Croatia, Israel, Italy, Japan, Lithuania, Romania, United States
 
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