Firdapse (previously Zenas) SERB SA · Authorised · authorised 23 Dec 2009 · ATC N07XX05
Therapeutic indication (EMA)
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Active substance
Amifampridine
- US FDA 1
- EMA 2
- Health Canada 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FIRDAPSE | EQ 10MG BASE | tablet · oral | CATALYST PHARMS | Prescription | 28 Nov 2018 |
EMA European Union — centrally authorised medicines
Amifampridine SERB SERB SA · Authorised · authorised 19 May 2022 · ATC N07XX05
Therapeutic indication (EMA)
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Canada Canada — marketed products (Health Canada)
Safety signals and safety-related labeling changes
- US FDA 30 May 2024 FIRDAPSE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.