Lemtrada
alemtuzumab
Table of contents
Overview
Lemtrada is a medicine that is used to treat adults with relapsing-remitting multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves as well as the nerves themselves. ‘Relapsing-remitting’ means that the patient has attacks (relapses) between periods with few or no symptoms (remissions).
Lemtrada is used for patients with:
- disease that is highly active, even though they have been treated with a disease-modifying therapy;
- rapidly worsening, severe disease, who have had 2 or more relapses in one year and whose brain scans show certain brain lesions.
Lemtrada contains the active substance alemtuzumab.
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List item
Lemtrada : EPAR - Medicine overview (PDF/131.15 KB)
First published: 25/09/2013
Last updated: 29/01/2020
EMA/653536/2019 -
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List item
Lemtrada : EPAR - Risk-management-plan summary (PDF/646.93 KB)
First published: 04/08/2021
Last updated: 19/07/2022
Authorisation details
Product details | |
---|---|
Name |
Lemtrada
|
Agency product number |
EMEA/H/C/003718
|
Active substance |
alemtuzumab
|
International non-proprietary name (INN) or common name |
alemtuzumab
|
Therapeutic area (MeSH) |
Multiple Sclerosis
|
Anatomical therapeutic chemical (ATC) code |
L04AA34
|
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. |
Publication details | |
---|---|
Marketing-authorisation holder |
Sanofi Belgium
|
Revision |
20
|
Date of issue of marketing authorisation valid throughout the European Union |
12/09/2013
|
Contact address |
Leonardo Da Vincilaan 19 |
Product information
07/09/2022 Lemtrada - EMEA/H/C/003718 - IB/0043
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
Therapeutic indication
Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.