Firdapse (previously Zenas) (amifampridine)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- amifampridine
- Company
- SERB SA
- Status
- Authorised
- Therapeutic area
- Lambert-Eaton Myasthenic Syndrome
- CHMP opinion
- Thu 22 Oct 2009
- EU approval
- Wed 23 Dec 2009
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/001032
- ATC
- N07XX05
- Official record
- www.ema.europa.eu
Indication
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Amifampridine SERB Authorised · SERB SA
Follow Firdapse (previously Zenas)
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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.