Dimethyl fumarate Teva

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dimethyl fumarate

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

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.

This EPAR was last updated on 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)
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AX07
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
Teva GmbH
Date of issue of marketing authorisation valid throughout the European Union
12/12/2022
Contact address

Graf-Arco-Straße 3
D-89079 Ulm
Germany

Product information

12/12/2022 Dimethyl fumarate Teva - EMEA/H/C/005963 -

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Product information documents contain:

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).

Assessment history

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