VYVGART
As listed in the register: VYVGART 1 000 mg, solution injectable en seringue préremplie
1 000 mg · solution injectable
- Prescription only
- Active substance
- Efgartigimod Alfa
- Made by
- ARGENX (BELGIQUE)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (VYVGART). It describes the substance, not this exact product.
Efgartigimod alfa-fcab is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
P450 Enzymes Efgartigimod alfa-fcab is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-13
Safety of the active substance
From the US prescribing label for the same active substance (VYVGART). It describes the substance, not this exact product.
- VYVGART is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of VYVGART.
- Reactions have included anaphylaxis and hypotension leading to syncope [see Warnings and Precautions (5.2) ].
Most common adverse reactions (≥ 10%) in patients treated with gMG are respiratory tract infections, headache, and urinary tract infection.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | ARGENX (BELGIQUE) |
|---|---|
| Active substance | Efgartigimod Alfa |
| Strength | 1 000 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | prescription réservée aux spécialistes et services NEUROLOGIE · médicament nécessitant une surveillance particulière pendant le traitement · prescription hospitalière · liste I · l'administration du 1 er cycle et de la 1 ère injection du 2 ème cycle doit être réalisée en milieu hospitalier |
| Marketed | Yes, according to the register |
| Reinforced monitoring | Yes — under reinforced monitoring, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/22/1674 |
| Name in the register | VYVGART 1 000 mg, solution injectable en seringue préremplie |
| Packs | 1 seringue(s) préremplie(s) en verre de 5 ml |
| CIS | 66446220 |
| CIP13 | 3400930315286 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- solution injectable2 products
1 000 mg2
1 000 mg · 2 companies
- ARGENX (BELGIQUE) · this page
- ARGENX (BELGIQUE)
- solution à diluer pour perfusion1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.