Vyvgart

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efgartigimod alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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 28/09/2022

Authorisation details

Product details
Name
Vyvgart
Agency product number
EMEA/H/C/005849
Active substance
Efgartigimod alfa
International non-proprietary name (INN) or common name
efgartigimod alfa
Therapeutic area (MeSH)
Myasthenia Gravis
Anatomical therapeutic chemical (ATC) code
L04AA58
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.

OrphanOrphan

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
Argenx
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
10/08/2022
Contact address

Industriepark-Zwijnaarde 7
B-9052 Gent
Belgium

Product information

22/09/2022 Vyvgart - EMEA/H/C/005849 - N/0021

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

Immunosuppressants

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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