Overview

This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works Polpharma, Cases C-438/21 P to C-440/21 P.

Dimethyl fumarate Neuraxpharm : EPAR - Medicine Overview

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slovenščina (SL) (1.69 MB - PDF)
Suomi (FI) (1.58 MB - PDF)
svenska (SV) (1.55 MB - PDF)

Dimethyl fumarate Neuraxpharm : EPAR - Risk management plan summary

Product information

Dimethyl fumarate Neuraxpharm : EPAR - Product Information

български (BG) (2.15 MB - PDF)
español (ES) (1.64 MB - PDF)
čeština (CS) (1.88 MB - PDF)
dansk (DA) (1.56 MB - PDF)
Deutsch (DE) (1.69 MB - PDF)
eesti keel (ET) (1.49 MB - PDF)
ελληνικά (EL) (2.19 MB - PDF)
français (FR) (1.69 MB - PDF)
hrvatski (HR) (1.63 MB - PDF)
íslenska (IS) (1.55 MB - PDF)
italiano (IT) (1.61 MB - PDF)
latviešu valoda (LV) (1.77 MB - PDF)
lietuvių kalba (LT) (1.75 MB - PDF)
magyar (HU) (1.91 MB - PDF)
Malti (MT) (1.79 MB - PDF)
Nederlands (NL) (1.62 MB - PDF)
norsk (NO) (1.59 MB - PDF)
polski (PL) (2.01 MB - PDF)
português (PT) (1.59 MB - PDF)
română (RO) (1.86 MB - PDF)
slovenčina (SK) (1.87 MB - PDF)
slovenščina (SL) (1.69 MB - PDF)
Suomi (FI) (1.58 MB - PDF)
svenska (SV) (1.55 MB - PDF)

Latest procedure affecting product information: EMEA/H/C/006039

13/12/2023

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This medicine’s product information is available in all official EU languages.
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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).

Dimethyl fumarate Neuraxpharm : EPAR - All authorised presentations

български (BG) (154 KB - PDF)
español (ES) (131.84 KB - PDF)
čeština (CS) (133.04 KB - PDF)
dansk (DA) (132.64 KB - PDF)
Deutsch (DE) (136.99 KB - PDF)
eesti keel (ET) (130.7 KB - PDF)
ελληνικά (EL) (152.03 KB - PDF)
français (FR) (159.18 KB - PDF)
hrvatski (HR) (149.97 KB - PDF)
íslenska (IS) (131.25 KB - PDF)
italiano (IT) (129.96 KB - PDF)
latviešu valoda (LV) (146.32 KB - PDF)
lietuvių kalba (LT) (145.31 KB - PDF)
magyar (HU) (146.17 KB - PDF)
Malti (MT) (145.76 KB - PDF)
Nederlands (NL) (131.09 KB - PDF)
norsk (NO) (131.8 KB - PDF)
polski (PL) (143.66 KB - PDF)
português (PT) (129.38 KB - PDF)
română (RO) (143.5 KB - PDF)
slovenčina (SK) (146.16 KB - PDF)
slovenščina (SL) (132.61 KB - PDF)
Suomi (FI) (132.06 KB - PDF)
svenska (SV) (126.53 KB - PDF)

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, Relapsing-Remitting
Anatomical therapeutic chemical (ATC) code
L04AX07

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Authorisation details

EMA product number
EMEA/H/C/006039

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
Laboratorios Lesvi S.L.

Avinguda Barcelona 69
Sant Joan Despi
08970 Barcelona
Spain

Opinion adopted
24/02/2022
Marketing authorisation issued
13/05/2022
Revision
5

Assessment history

Dimethyl fumarate Neuraxpharm : EPAR - Procedural steps taken and scientific information after authorisation

Dimethyl fumarate Neuraxpharm : EPAR - Public Assessment Report

CHMP summary of positive opinion for Dimethyl fumarate Neuraxpharm

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