Dimethyl fumarate Teva
dimethyl fumarate
Table of contents
Overview
Dimethyl fumarate Teva 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).
Dimethyl fumarate Teva is a ‘generic medicine’. This means that Dimethyl fumarate Teva contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Tecfidera. For more information on generic medicines, see the question-and-answer document here.
Dimethyl fumarate Teva contains the active substance dimethyl fumarate.
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Dimethyl fumarate Teva: EPAR - Medicine overview (PDF/144.22 KB)
First published: 21/12/2022
EMEA/H/C/005963 -
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Dimethyl fumarate Teva: EPAR - Risk management plan summary (PDF/367.16 KB)
First published: 21/12/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Dimethyl fumarate Teva
|
| Agency product number |
EMEA/H/C/005963
|
| Active substance |
dimethyl fumarate
|
| International non-proprietary name (INN) or common name |
dimethyl fumarate
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L04AX07
|
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 | |
|---|---|
| Marketing-authorisation holder |
Teva GmbH
|
| Date of issue of marketing authorisation valid throughout the European Union |
12/12/2022
|
| Contact address |
Graf-Arco-Straße 3 |
Product information
12/12/2022 Dimethyl fumarate Teva - EMEA/H/C/005963 -
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
Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).