Dimethyl fumarate Polpharma
dimethyl fumarate
Table of contents
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.
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Dimethyl fumarate Polpharma : EPAR - Medicine Overview (PDF/125.3 KB)
First published: 24/05/2022
EMA/127784/2022 -
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Dimethyl fumarate Polpharma : EPAR - Risk management plan summary (PDF/118.19 KB)
First published: 24/05/2022
Authorisation details
Product details | |
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Name |
Dimethyl fumarate Polpharma
|
Agency product number |
EMEA/H/C/005955
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Active substance |
dimethyl fumarate
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International non-proprietary name (INN) or common name |
dimethyl fumarate
|
Therapeutic area (MeSH) |
Multiple Sclerosis, Relapsing-Remitting
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Anatomical therapeutic chemical (ATC) code |
L04AX07
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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 | |
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Marketing-authorisation holder |
Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
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Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
13/05/2022
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Contact address |
Ul. Pelplinska 19 |
Product information
30/06/2023 Dimethyl fumarate Polpharma - EMEA/H/C/005955 - N/0007
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.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.