Lemtrada (alemtuzumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- alemtuzumab
- Company
- Sanofi Belgium
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- CHMP opinion
- Thu 27 Jun 2013
- EU approval
- Thu 12 Sep 2013
- Designations
- Additional monitoring
- Application
- EMEA/H/C/003718
- ATC
- L04AA34
- Official record
- www.ema.europa.eu
Indication
Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 MabCampath Withdrawn · Genzyme Europe B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.