efgartigimod alfa

This medicine is authorised for use in the European Union.


Vyvgart is a medicine for treating adults with generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness) and whose immune system produce antibodies against a protein called acetylcholine receptor, located on muscle cells. It is given together with other medicines used for the treatment of myasthenia gravis.

Myasthenia gravis is rare, and Vyvgart was designated an ‘orphan medicine’ on 21 March 2018.

Vyvgart contains the active substance efgartigimod alfa.

This EPAR was last updated on 22/11/2022

Authorisation details

Product details
Agency product number
Active substance
Efgartigimod alfa
International non-proprietary name (INN) or common name
efgartigimod alfa
Therapeutic area (MeSH)
Myasthenia Gravis
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Industriepark-Zwijnaarde 7
B-9052 Gent

Product information

22/11/2022 Vyvgart - EMEA/H/C/005849 - IB/0002/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti acetylcholine receptor (AChR) antibody positive.

Assessment history

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