Tecfidera
dimethyl fumarate
Table of contents
Overview
Tecfidera is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults and children from 13 years of age with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Tecfidera contains the active substance dimethyl fumarate.
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List item
Tecfidera : EPAR - Medicine overview (PDF/112.97 KB)
First published: 26/02/2014
Last updated: 25/05/2022
EMA/62880/2022 -
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List item
Tecfidera : EPAR - Risk Management Plan (PDF/1.17 MB)
First published: 30/11/2022
Authorisation details
Product details | |
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Name |
Tecfidera
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Agency product number |
EMEA/H/C/002601
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Active substance |
dimethyl fumarate
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International non-proprietary name (INN) or common name |
dimethyl fumarate
|
Therapeutic area (MeSH) |
Multiple Sclerosis
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Anatomical therapeutic chemical (ATC) code |
L04AX07
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Publication details | |
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Marketing-authorisation holder |
Biogen Netherlands B.V.
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Revision |
28
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Date of issue of marketing authorisation valid throughout the European Union |
30/01/2014
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Contact address |
Prins Mauritslaan 13 |
Product information
15/09/2023 Tecfidera - EMEA/H/C/002601 - R/0083
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
Immunosuppressants
Therapeutic indication
Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Assessment history
News
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22/04/2022
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25/02/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 202228/01/2022
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23/10/2015
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
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07/11/2014
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22/11/2013