Vyvgart
efgartigimod alfa
Table of contents
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.
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List item
Vyvgart : EPAR - Medicine Overview (PDF/119.23 KB)
First published: 12/09/2022
Last updated: 28/09/2022
EMA/786363/2022 -
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Vyvgart : EPAR - Risk management plan summary (PDF/162.98 KB)
First published: 12/09/2022
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 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Argenx
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
10/08/2022
|
Contact address |
Industriepark-Zwijnaarde 7 |
Product information
22/11/2022 Vyvgart - EMEA/H/C/005849 - IB/0002/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.