🇪🇺 Alemtuzumab (GZ402673) in European Union

EMA authorised Alemtuzumab (GZ402673) on 12 September 2013

Marketing authorisation

EMA — authorised 12 September 2013

  • Application: EMEA/H/C/003718
  • Marketing authorisation holder: Sanofi Belgium
  • Local brand name: Lemtrada
  • Indication: Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
  • Status: approved

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Frequently asked questions

Is Alemtuzumab (GZ402673) approved in European Union?

Yes. EMA authorised it on 12 September 2013.

Who is the marketing authorisation holder for Alemtuzumab (GZ402673) in European Union?

Sanofi Belgium holds the EU marketing authorisation.