Lemtrada

RSS

alemtuzumab

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

Overview

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.

This EPAR was last updated on 09/07/2018

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
Publication details
Marketing-authorisation holder
Genzyme Therapeutics Ltd
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
12/09/2013
Contact address
4620 Kingsgate
Cascade Way
Oxford Business Park South
Oxford
OX4 2SU
United Kingdom

Product information

02/07/2018 Lemtrada - EMEA/H/C/003718 - R/0020

Contents

  • 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.

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

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