Firdapse (previously Zenas)

RSS

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 08/08/2018

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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
BioMarin International Limited
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
23/12/2009
Contact address
Shanbally, Ringaskiddy
County Cork, P43 R298
Ireland

Product information

13/07/2018 Firdapse (previously Zenas) - EMEA/H/C/001032 - T/0057

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

OTHER NERVOUS SYSTEM DRUGS

Therapeutic indication

Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

Assessment history

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