EMA — authorised 23 December 2009
- Marketing authorisation holder: BioMarin Europe Ltd
- Status: approved
🇪🇺 Firdapse in European Union
EMA authorised Firdapse on 23 December 2009
Marketing authorisations
EMA — authorised 23 December 2009
- Application: EMEA/H/C/001032
- Marketing authorisation holder: SERB SA
- Local brand name: Firdapse (previously Zenas)
- Indication: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
- Pathway: exceptional circumstances
- Status: approved
EMA — authorised 19 May 2022
- Application: EMEA/H/C/005839
- Marketing authorisation holder: SERB SA
- Local brand name: Amifampridine SERB
- Indication: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
- Status: approved
Firdapse in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in European Union
Frequently asked questions
Is Firdapse approved in European Union?
Yes. EMA authorised it on 23 December 2009; EMA authorised it on 23 December 2009; EMA authorised it on 19 May 2022.
Who is the marketing authorisation holder for Firdapse in European Union?
BioMarin Europe Ltd holds the EU marketing authorisation.