Dimethyl fumarate Teva

dimethyl fumarate

Overview
Authorisation details
Product information
Assessment history

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.

: Dimethyl fumarate Teva can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.
Dimethyl fumarate Teva is available as capsules to be taken by mouth with food. The dose is 120 mg twice a day for the first seven days, after which it is increased to 240 mg twice a day. The dose may be reduced temporarily in patients experiencing flushing and gastrointestinal (stomach and gut) problems as side effects.
For more information about using Dimethyl fumarate Teva, see the package leaflet or contact your doctor or pharmacist.

: In MS, the immune system (the body’s natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and the optic nerve of the eye), causing inflammation that damages the nerves and the insulation around them. The active substance in this medicine, dimethyl fumarate, is thought to work by activating a protein called ‘Nrf2’. This protein regulates certain genes producing ‘antioxidants’ that help protect cells from damage. Dimethyl fumarate has been shown to reduce inflammation and modulate the activity of the immune system.

: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Tecfidera, and do not need to be repeated for Dimethyl fumarate Teva.
As for every medicine, the company provided studies on the quality of Dimethyl fumarate Teva. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

: Because Dimethyl fumarate Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The European Medicines Agency concluded that, in accordance with EU requirements, Dimethyl fumarate Teva has been shown to have comparable quality and to be bioequivalent to the reference medicine. Therefore, the Agency’s view was that, as for Tecfidera, the benefits of Dimethyl fumarate Teva outweigh the identified risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dimethyl fumarate Teva have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Dimethyl fumarate Teva are continuously monitored. Suspected side effects reported with Dimethyl fumarate Teva are carefully evaluated and any necessary action taken to protect patients.

: Dimethyl fumarate Teva received a marketing authorisation valid throughout the EU on 12 December 2022.
This overview was last updated in 12-2022.

List item

Dimethyl fumarate Teva: EPAR - Medicine overview (PDF/144.22 KB)

First published: 21/12/2022
EMEA/H/C/005963
- Bulgarian
  (PDF/157.27 KB)
- Croatian
  (PDF/153.39 KB)
- Czech
  (PDF/155.13 KB)
- Danish
  (PDF/134.64 KB)
- Dutch
  (PDF/135.04 KB)
- Estonian
  (PDF/123.35 KB)
- Finnish
  (PDF/132.84 KB)
- French
  (PDF/137.01 KB)
- German
  (PDF/138.18 KB)
- Greek
  (PDF/159.25 KB)
- Hungarian
  (PDF/156.5 KB)
- Italian
  (PDF/133.32 KB)
- Latvian
  (PDF/173.15 KB)
- Lithuanian
  (PDF/155.11 KB)
- Maltese
  (PDF/158.25 KB)
- Polish
  (PDF/157.89 KB)
- Portuguese
  (PDF/135.73 KB)
- Romanian
  (PDF/154 KB)
- Slovak
  (PDF/154.75 KB)
- Slovenian
  (PDF/152.46 KB)
- Spanish
  (PDF/135.32 KB)
- Swedish
  (PDF/133.34 KB)
List item

Dimethyl fumarate Teva: EPAR - Risk management plan summary (PDF/367.16 KB)

First published: 21/12/2022

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
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 D-89079 Ulm Germany

Product information

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

List item

Dimethyl fumarate Teva: EPAR - Product information (PDF/695.18 KB)

First published: 21/12/2022
- Bulgarian
  (PDF/780.36 KB)
- Croatian
  (PDF/720.1 KB)
- Czech
  (PDF/718.57 KB)
- Danish
  (PDF/642.67 KB)
- Dutch
  (PDF/634.29 KB)
- Estonian
  (PDF/652.23 KB)
- Finnish
  (PDF/644.1 KB)
- French
  (PDF/662.09 KB)
- German
  (PDF/658.46 KB)
- Greek
  (PDF/815.82 KB)
- Hungarian
  (PDF/761.33 KB)
- Icelandic
  (PDF/668.49 KB)
- Italian
  (PDF/652.28 KB)
- Latvian
  (PDF/716.37 KB)
- Lithuanian
  (PDF/738.67 KB)
- Maltese
  (PDF/749.48 KB)
- Norwegian
  (PDF/659.59 KB)
- Polish
  (PDF/731.17 KB)
- Portuguese
  (PDF/670.77 KB)
- Romanian
  (PDF/759.72 KB)
- Slovak
  (PDF/744.42 KB)
- Slovenian
  (PDF/676.87 KB)
- Spanish
  (PDF/636.45 KB)
- Swedish
  (PDF/685.52 KB)

Other EU languages available icon 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.

List item

Dimethyl fumarate Teva: EPAR - All authorised presentations (PDF/27.94 KB)

First published: 21/12/2022
- Bulgarian
  (PDF/85.88 KB)
- Croatian
  (PDF/47.98 KB)
- Czech
  (PDF/37.85 KB)
- Danish
  (PDF/27.82 KB)
- Dutch
  (PDF/28.97 KB)
- Estonian
  (PDF/28.14 KB)
- Finnish
  (PDF/27.81 KB)
- French
  (PDF/28.33 KB)
- German
  (PDF/28.7 KB)
- Greek
  (PDF/54.2 KB)
- Hungarian
  (PDF/47.47 KB)
- Icelandic
  (PDF/28.61 KB)
- Italian
  (PDF/28.12 KB)
- Latvian
  (PDF/52.11 KB)
- Lithuanian
  (PDF/52.52 KB)
- Maltese
  (PDF/50.16 KB)
- Norwegian
  (PDF/22.99 KB)
- Polish
  (PDF/49.81 KB)
- Portuguese
  (PDF/29.5 KB)
- Romanian
  (PDF/50.23 KB)
- Slovak
  (PDF/47.29 KB)
- Slovenian
  (PDF/36.66 KB)
- Spanish
  (PDF/28.77 KB)
- Swedish
  (PDF/23.8 KB)

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

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022

14/10/2022

Dimethyl fumarate Teva

Table of contents

Overview