Fampridine Accord

RSS

fampridine

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

Overview

Fampridine Accord is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.

MS is a disease in which the immune system (the body’s defences) attacks and damages the covering around the nerves and the nerves themselves in the brain and spinal cord.

Fampridine Accord is a ‘generic medicine’. This means that Fampridine Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Fampyra. For more information on generic medicines, see the question-and-answer document below.

Fampridine Accord contains the active substance fampridine.

This EPAR was last updated on 02/10/2020

Authorisation details

Product details
Name
Fampridine Accord
Agency product number
EMEA/H/C/005359
Active substance
Fampridine
International non-proprietary name (INN) or common name
fampridine
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
N07XX07
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
24/09/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

24/09/2020 Fampridine Accord - EMEA/H/C/005359 -

Contents

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Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Fampridine Accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). 

Assessment history

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