Saphnelo

RSS

anifrolumab

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

Overview

Saphnelo is a medicine used as an add-on treatment in adults with systemic lupus erythematosus (SLE), a disease in which the immune system (the body’s natural defences) attacks normal cells and tissues, causing inflammation and organ damage.

Saphnelo is given to patients who have antibodies against their own cells (autoantibodies) and whose disease is still moderate to severe despite standard treatment.

Saphnelo contains the active substance anifrolumab.

This EPAR was last updated on 21/02/2022

Authorisation details

Product details
Name
Saphnelo
Agency product number
EMEA/H/C/004975
Active substance
anifrolumab
International non-proprietary name (INN) or common name
anifrolumab
Therapeutic area (MeSH)
Lupus Erythematosus, Systemic
Anatomical therapeutic chemical (ATC) code
L04AA
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
AstraZeneca AB
Date of issue of marketing authorisation valid throughout the European Union
14/02/2022
Contact address

AstraZeneca AB
Sodertalje
SE-151 85 Sodertalje
Sweden

Product information

Saphnelo - EMEA/H/C/004975 -

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

Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.

Assessment history

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