This is a summary of the European public assessment report (EPAR) for Lemtrada. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Lemtrada.
For practical information about using Lemtrada, patients should read the package leaflet or contact their doctor or pharmacist.
Lemtrada : EPAR - Summary for the public (PDF/73.81 KB)
First published: 25/09/2013
Last updated: 08/02/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Genzyme Therapeutics Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
02/07/2018 Lemtrada - EMEA/H/C/003718 - R/0020
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.