This is a summary of the European public assessment report (EPAR) for Firdapse. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Firdapse.
Therapeutic Indication
### Therapeutic indication Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Therapeutic Area (MeSH)
ATC Code
N07XX05
ATC Item
amifampridine
Pharmacotherapeutic Group
Other nervous system drugs
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| amifampridine | N/A | 阿米吡啶 |
EMA Name
Firdapse (previously Zenas)
Medicine Name
Firdapse (previously Zenas)
Aliases
N/ANo risk management plan link.