Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Lemtrada   
Auth. number : EU/1/13/869
Active substance : Alemtuzumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA34 - alemtuzumab
(See WHO ATC Index)
Indication: LEMTRADA is indicated for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Marketing Authorisation Holder: Genzyme Therapeutics Ltd
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/09/2013 Centralised - Authorisation EMEA/H/C/3718 (2013)5927 of 12/09/2013
17/12/2013 Centralised - Variation EMEA/H/C/3718/IA/2
Updated with Decision(2014)9995 of 15/12/2014
17/12/2014 Centralised - Yearly update (2014)9995 of 15/12/2014
23/06/2016 PSUSA - Modification EMEA/H/C/3718/PSUSA/10055/201509 (2016) 3959 of 21/06/2016
17/11/2017 Centralised - 2-Monthly update EMEA/H/C/3718/II/17 (2017) 7765 of 15/11/2017
13/12/2017 PSUSA - Modification EMEA/H/C/3718/PSUSA/10055/201703 (2017) 8616 of 08/12/2017