Firdapse (previously Zenas)
amifampridine
Table of contents
Overview
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.
Authorisation details
Product details | |
---|---|
Name |
Firdapse (previously Zenas)
|
Agency product number |
EMEA/H/C/001032
|
Active substance |
amifampridine
|
International non-proprietary name (INN) or common name |
amifampridine
|
Therapeutic area (MeSH) |
Lambert-Eaton Myasthenic Syndrome
|
Anatomical therapeutic chemical (ATC) code |
N07XX05
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Exceptional circumstances |
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance. |
Publication details | |
---|---|
Marketing-authorisation holder |
SERB SA
|
Revision |
21
|
Date of issue of marketing authorisation valid throughout the European Union |
23/12/2009
|
Contact address |
Avenue Louise 480 |
Product information
22/07/2021 Firdapse (previously Zenas) - EMEA/H/C/001032 - S/0071
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Other nervous system drugs
Therapeutic indication
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.