Kesimpta

RSS

ofatumumab

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

Overview

Kesimpta is a medicine for treating adults with relapsing forms of multiple sclerosis (MS), where the patient has flare-ups (relapses) followed by periods with milder or no symptoms. It is used in patients with active disease, which means that they have relapses and/or signs of active inflammation on scans.

Kesimpta contains the active substance ofatumumab.

This EPAR was last updated on 16/01/2023

Authorisation details

Product details
Name
Kesimpta
Agency product number
EMEA/H/C/005410
Active substance
ofatumumab
International non-proprietary name (INN) or common name
ofatumumab
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code
L04AA52
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
Novartis Ireland Ltd
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Vista Building Elm Park
Merrion Road
Ballsbridge
Dublin 4
D04 A9N6
Ireland

Product information

13/01/2022 Kesimpta - EMEA/H/C/005410 - IAIN/0011

Other EU languages available icon 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:

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

Immunosuppressant

Therapeutic indication

Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).

Assessment history

Related content

How useful was this page?

Add your rating
Average
4 ratings
4 ratings