Lemtrada

RSS

alemtuzumab

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

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.

This EPAR was last updated on 21/07/2020

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 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
Sanofi Belgium
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
12/09/2013
Contact address

Leonardo Da Vincilaan 19
B-1831 Diegem
Belgium

Product information

03/07/2020 Lemtrada - EMEA/H/C/003718 - PSUSA/00010055/201909

Contents

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Pharmacotherapeutic group

Selective immunosuppressants

Therapeutic indication

Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

Assessment history

Changes since initial authorisation of medicine

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