Dimethyl fumarate Neuraxpharm

Revoked

This medicine's authorisation has been revoked

dimethyl fumarate

Overview

On 13 December 2023, the European Commission revoked the marketing authorisation for Dimethyl fumarate Neuraxpharm (dimethyl fumarate) in the European Union (EU). Dimethyl fumarate Neuraxpharm was a generic medicine of Tecfidera. The marketing authorisation holder for the medicine was Laboratorios Lesvi S.L. 

The revocation of the marketing authorisation was necessary 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. It follows from that judgment that the marketing authorisation for Dimethyl fumarate Neuraxpharm was submitted at a point in time when the regulatory data protection period of the reference product (Tecfidera) had not expired. 

Further information in relation to the revocation of Dimethyl fumarate Neuraxpharm may be found in the Commission Implementing Decision revoking the marketing authorisation, which is available on the Union Register of medicinal products for human use. Dimethyl fumarate Neuraxpharm was granted marketing authorisation in the EU on 13 May 2022 for treatment of relapsing remitting multiple sclerosis (RRMS).

Following a new application by the company, a marketing authorisation was granted by the European Commission on 22 April 2024.

Dimethyl fumarate Neuraxpharm : EPAR - Medicine Overview

Reference Number: EMA/127511/2022

Dimethyl fumarate Neuraxpharm : EPAR - Risk management plan summary

Product information

Dimethyl fumarate Neuraxpharm : EPAR - Product Information

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

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
• Revocation of marketing authorisation:
  13/12/2023
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Dimethyl fumarate Neuraxpharm : EPAR - Public Assessment Report

AdoptedReference Number: EMA/CHMP/153578/2022

CHMP summary of positive opinion for Dimethyl fumarate Neuraxpharm

AdoptedReference Number: EMA/CHMP/102451/2022