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 05/05/2022

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
Biogen Netherlands B.V. 
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
20/07/2011
Contact address

Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Product information

25/04/2022 Fampyra - EMEA/H/C/002097 - R/0050

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:

  • 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

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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