Dimethyl fumarate Polpharma

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dimethyl fumarate

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

Overview

Dimethyl fumarate Polpharma 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 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 Polpharma contains the active substance dimethyl fumarate and is a ‘generic medicine’. This means that Dimethyl fumarate Polpharma 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.

This EPAR was last updated on 16/01/2023

Authorisation details

Product details
Name
Dimethyl fumarate Polpharma
Agency product number
EMEA/H/C/005955
Active substance
dimethyl fumarate
International non-proprietary name (INN) or common name
dimethyl fumarate
Therapeutic area (MeSH)
Multiple Sclerosis, Relapsing-Remitting
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
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
13/05/2022
Contact address

Ul. Pelplinska 19
83-200 Starogard
Gdanski
Poland

Product information

13/01/2023 Dimethyl fumarate Polpharma - EMEA/H/C/005955 - IB/0006

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:

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 Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Assessment history

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