Dimethyl fumarate Teva

Revoked

This medicine's authorisation has been revoked

dimethyl fumarate

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This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works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 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