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This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works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
Dimethyl fumarate Neuraxpharm : EPAR - Risk management plan summary
Product information
Dimethyl fumarate Neuraxpharm : EPAR - Product Information
Latest procedure affecting product information: EMEA/H/C/006039
13/12/2023
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).
Dimethyl fumarate Neuraxpharm : EPAR - All authorised presentations
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
ImmunosuppressantsTherapeutic indication
Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Assessment history
Dimethyl fumarate Neuraxpharm : EPAR - Procedural steps taken and scientific information after authorisation