Firdapse (previously Zenas)

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amifampridine

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 25/05/2022

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 monitoringAdditional 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 circumstancesExceptional 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
1050 Brussels
Belgium

Product information

22/07/2021 Firdapse (previously Zenas) - EMEA/H/C/001032 - S/0071

Other EU languages available icon 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:

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.

Assessment history

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