Lupkynis

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voclosporin

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

Overview

Lupkynis is a medicine used to treat lupus nephritis, a manifestation of a disease called systemic lupus erythematosus. In lupus nephritis, the immune system (the body’s natural defences) attacks the kidneys, causing inflammation and kidney damage.

Lupkynis is used together with another medicine called mycophenolate mofetil in adults with active class III, IV or V lupus nephritis, which are severe forms of the condition. 

Lupkynis contains the active substance voclosporin.
 

This EPAR was last updated on 20/09/2022

Authorisation details

Product details
Name
Lupkynis
Agency product number
EMEA/H/C/005256
Active substance
Voclosporin
International non-proprietary name (INN) or common name
voclosporin
Therapeutic area (MeSH)
Lupus Nephritis
Anatomical therapeutic chemical (ATC) code
L04AD03
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.

Publication details
Marketing-authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Date of issue of marketing authorisation valid throughout the European Union
15/09/2022
Contact address

Herikerbergweg 292
1101 CT Amsterdam
Netherlands

Product information

15/09/2022 Lupkynis - EMEA/H/C/005256 -

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

Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

Assessment history

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