Overview

Dimethyl fumarate Mylan 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 Mylan contains the active substance dimethyl fumarate and is a ‘generic medicine’. This means that Dimethyl fumarate Mylan 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 Mylan is Tecfidera. For more information on generic medicines, see the question-and-answer document here.

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

Dimethyl fumarate Mylan 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 Mylan, 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 Mylan.

As for every medicine, the company provided studies on the quality of Dimethyl fumarate Mylan. 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 Mylan 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 Mylan 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 Mylan 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 Mylan have been included in the summary of product characteristics and the package leaflet.

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

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

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Product information

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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).

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Product details

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

Authorisation details

EMA product number
EMEA/H/C/006397

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.

Marketing authorisation holder
Mylan Ireland Limited

Unit 35/36
Grange Parade
Baldoye
Industrial Estate
Dublin 13
Ireland

Opinion adopted
21/03/2024
Opinion status
Positive
Marketing authorisation issued
22/04/2024

Assessment history

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