Is Efgartigimod alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Efgartigimod alfa, including Vyvgart (20 mg/ml, Concentrate for solution for infusion, SAR 33804.35).

Is Efgartigimod alfa approved by the US FDA?

Drugs@FDA lists 1 application product line for Efgartigimod alfa, including VYVGART (Prescription).

Is Efgartigimod alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Efgartigimod alfa: Vyvgart.

Are there safety signals or safety updates for Efgartigimod alfa?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-05-08).

Active substance

Efgartigimod alfa

SFDA 1
US FDA 1
EMA 1
Health Canada 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Vyvgart	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 33804.35	Biological · Prescription	Argenx BV	Valid

Indications — CHI Daman Drug Formulary

MYASTHENIA GRAVIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VYVGART	400MG	injectable · injection	ARGENX BV	Prescription	17 Dec 2021

EMA European Union — centrally authorised medicines

Vyvgart Argenx · Authorised · authorised 10 Aug 2022 · ATC L04AA58

Therapeutic indication (EMA)

Vyvgart is indicated as- an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are antiacetylcholine receptor (AChR) antibody positive.- monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VYVGART	02541599	20 MG / ML	SOLUTION · INTRAVENOUS	ARGENX BV
VYVGART SC	02562634	200 MG / ML	SOLUTION · SUBCUTANEOUS	ARGENX BV

Safety signals and safety-related labeling changes

US FDA 8 May 2026 VYVGART — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 May 2023 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No

All safety entries for efgartigimod alfa →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.