Dimethyl fumarate Teva

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This medicine's authorisation has been revoked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 Teva (dimethyl fumarate) in the European Union (EU). Dimethyl fumarate Teva was a generic medicine of Tecfidera. The marketing authorisation holder for the medicine was TEVA GmbH. 

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 Teva 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 Teva 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 Teva was granted marketing authorisation in the EU on 12 December 2022 for treatment of relapsing remitting multiple sclerosis (RRMS). 

The European Public Assessment Report (EPAR) for Dimethyl fumarate Teva is updated to indicate that the marketing authorisation is no longer valid.

Dimethyl fumarate Teva: EPAR - Medicine overview

Reference Number: EMEA/H/C/005963

Dimethyl fumarate Teva: EPAR - Risk management plan summary

Product information

Dimethyl fumarate Teva: EPAR - Product information

Dimethyl fumarate Teva: EPAR - All authorised presentations

Product details

• Name of medicine:
  Dimethyl fumarate Teva
• 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 Teva 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/005963
• 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:
  Teva GmbH

  Graf-Arco-Straße 3; D-89079 Ulm; Germany

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

Assessment history

Initial marketing authorisation documents

Dimethyl fumarate Teva: EPAR - Public Assessment Report

CHMP summary of positive opinion for Dimethyl fumarate Teva

AdoptedReference Number: EMA/CHMP/790837/2022