Fampyra

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fampridine

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

Overview

This is a summary of the European public assessment report (EPAR) for Fampyra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fampyra.

For practical information about using Fampyra, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/08/2018

Authorisation details

Product details
Name
Fampyra
Agency product number
EMEA/H/C/002097
Active substance
Fampridine
International non-proprietary name (INN) or common name
fampridine
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
N07XX07
Publication details
Marketing-authorisation holder
Blogen Netherlands B.V. 
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
20/07/2011
Contact address
Blogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

02/08/2018 Fampyra - EMEA/H/C/002097 - T/0043

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

Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (Expanded Disability Status Scale 4-7).

Assessment history

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