Fampridine Accord
fampridine
Table of contents
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.
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Fampridine Accord : EPAR - Medicine overview (PDF/140.2 KB)
First published: 02/10/2020
EMA/410661/2020 -
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Fampridine Accord : EPAR - Risk-management-plan summary (PDF/261.5 KB)
First published: 02/10/2020
Authorisation details
Product details | |
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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
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Anatomical therapeutic chemical (ATC) code |
N07XX07
|
Generic |
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 | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
|
Revision |
1
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Date of issue of marketing authorisation valid throughout the European Union |
24/09/2020
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Contact address |
Accord Healthcare S.L.U. |
Product information
06/05/2022 Fampridine Accord - EMEA/H/C/005359 - IB/0001
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
Fampridine Accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).