Dimethyl fumarate Accord

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This medicine's authorisation has been revoked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 Accord (dimethyl fumarate) in the European Union (EU). Dimethyl fumarate Accord was a generic medicine of Tecfidera. The marketing authorisation holder for the medicine was Accord Healthcare S.L.U. 

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 Accord 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 Accord 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 Accord was granted marketing authorisation in the EU on 15 February 2023 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 Accord : EPAR - Medicine overview

Reference Number: EMEA/H/C/005950

Dimethyl fumarate Accord : EPAR - Risk-management-plan summary

Product information

Dimethyl fumarate Accord : EPAR - Product information

Dimethyl fumarate Accord : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Dimethyl fumarate Accord
• Active substance:
  dimethyl fumarate
• International non-proprietary name (INN) or common name:
  dimethyl fumarate
• Therapeutic area (MeSH):
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis
• Anatomical therapeutic chemical (ATC) code:
  L04AX07

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Authorisation details

• EMA product number:
  EMEA/H/C/005950
• 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:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  13/10/2022
• Marketing authorisation issued:
  15/02/2023
• Revocation of marketing authorisation:
  13/12/2023

Assessment history

Initial marketing authorisation documents

Dimethyl fumarate Accord : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/2411/2023

CHMP summary of positive opinion for Dimethyl fumarate Accord

AdoptedReference Number: EMA/CHMP/922592/2022