Dimethyl fumarate Neuraxpharm | European Medicines Agency (EMA)

February 14, 2025

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Overview

Dimethyl fumarate Neuraxpharm 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 adolescents 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 Neuraxpharm contains the active substance dimethyl fumarate and is a ‘generic medicine’. This means that Dimethyl fumarate Neuraxpharm contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Dimethyl fumarate Neuraxpharm is Tecfidera. For more information on generic medicines, see the question-and-answer document here.

Dimethyl fumarate Neuraxpharm can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.

Dimethyl fumarate Neuraxpharm is available as capsules to be taken by mouth, twice a day with food. During the first week of treatment a lower dose is taken, which is then increased from the second week. The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal (stomach and gut) problems.

For more information about using Dimethyl fumarate Neuraxpharm, see the package leaflet or contact your doctor or pharmacist.

In MS, the immune system (the body’s natural defences) attacks and damages the protective insulation around the nerves and the nerves themselves in the brain, spinal cord and optic nerve of the eye. The active substance in this medicine, dimethyl fumarate, is thought to work by activating a protein called ‘Nrf2’ that regulates certain genes that produce ‘antioxidants’ involved in protecting 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 Neuraxpharm.

As for every medicine, the company provided studies on the quality of Dimethyl fumarate Neuraxpharm. 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 Neuraxpharm 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 Neuraxpharm has been shown to have comparable quality and to be bioequivalent to Tecfidera. Therefore, the Agency’s view was that, as for Tecfidera, the benefits of Dimethyl fumarate Neuraxpharm 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 Neuraxpharm have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Dimethyl fumarate Neuraxpharm are continuously monitored. Suspected side effects reported with Dimethyl fumarate Neuraxpharm are carefully evaluated and any necessary action taken to protect patients.

Dimethyl fumarate Neuraxpharm received a marketing authorisation valid throughout the EU on 22 April 2024.

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First published: 11/07/2024

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First published: 11/07/2024

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Product information

English (EN)
(395.91 KB – PDF)

First published: 11/07/2024Last updated: 13/02/2025

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Latest procedure affecting product information:
VR/0000246862

12/02/2025

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).

English (EN)
(23.7 KB – PDF)

First published: 11/07/2024

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Product details

Name of medicine: Dimethyl fumarate Neuraxpharm
Active substance: dimethyl fumarate
International non-proprietary name (INN) or common name: dimethyl fumarate
Therapeutic area (MeSH): Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code: L04AX07

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Dimethyl fumarate Neuraxpharm is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

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Dimethyl fumarate Neuraxpharm | European Medicines Agency (EMA)

Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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Overview

How is Dimethyl fumarate Neuraxpharm used?

How does Dimethyl fumarate Neuraxpharm work?

How has Dimethyl fumarate Neuraxpharm been studied?

What are the benefits and risks of Dimethyl fumarate Neuraxpharm?

Why is Dimethyl fumarate Neuraxpharm authorised in the EU?

What measures are being taken to ensure the safe and effective use of Dimethyl fumarate Neuraxpharm?

Other information about Dimethyl fumarate Neuraxpharm

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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