🇪🇺 Tecfidera in European Union

EMA authorised Tecfidera on 24 March 2022

Marketing authorisations

EMA — authorised 24 March 2022

  • Application: EMEA/H/C/006042
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Dimherity
  • Indication: Treatment of multiple sclerosis.
  • Status: withdrawn

Read official source →

EMA — authorised 13 May 2022

  • Application: EMEA/H/C/005955
  • Marketing authorisation holder: Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
  • Local brand name: Dimethyl fumarate Polpharma
  • Indication: Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
  • Status: withdrawn

Read official source →

EMA — authorised 13 May 2022

  • Application: EMEA/H/C/005956
  • Marketing authorisation holder: Mylan Ireland Limited
  • Local brand name: Dimethyl fumarate Mylan
  • Indication: Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
  • Status: withdrawn

Read official source →

EMA — authorised 13 May 2022

  • Application: EMEA/H/C/006039
  • Marketing authorisation holder: Laboratorios Lesvi S.L.
  • Local brand name: Dimethyl fumarate Neuraxpharm
  • Indication: Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
  • Status: withdrawn

Read official source →

EMA — authorised 12 December 2022

  • Application: EMEA/H/C/005963
  • Marketing authorisation holder: Teva GmbH
  • Local brand name: Dimethyl fumarate Teva
  • 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).
  • Status: withdrawn

Read official source →

EMA — authorised 15 February 2023

  • Application: EMEA/H/C/005950
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Dimethyl fumarate Accord
  • 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).
  • Status: withdrawn

Read official source →

EMA — authorised 22 April 2024

  • Application: EMEA/H/C/006397
  • Marketing authorisation holder: Mylan Pharmaceuticals Limited
  • Local brand name: Dimethyl fumarate Mylan
  • Indication: Dimethyl fumarate Mylan is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
  • Status: approved

The European Medicines Agency (EMA) has approved Dimethyl fumarate Mylan (Tecfidera) for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). This approval was granted on 22 April 2024. The marketing authorisation holder is Mylan Pharmaceuticals Limited.

Read official source →

EMA — authorised 22 April 2024

  • Application: EMEA/H/C/006471
  • Marketing authorisation holder: Accord Healthcare Ltd
  • Local brand name: Dimethyl fumarate Accord
  • 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).
  • Status: approved

The European Medicines Agency (EMA) approved Dimethyl fumarate Accord (Tecfidera) for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). This approval was granted on 22 April 2024. The marketing authorisation holder is Accord Healthcare Ltd, and the local brand name is Dimethyl fumarate Accord. This approval was granted through the standard expedited pathway.

Read official source →

EMA — authorised 22 April 2024

  • Application: EMEA/H/C/006500
  • Marketing authorisation holder: Neuraxpharm Pharmaceuticals S.L.
  • Local brand name: Dimethyl fumarate Neuraxpharm
  • Indication: Dimethyl fumarate Neuraxpharm is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
  • Status: approved

The European Medicines Agency (EMA) has approved Dimethyl fumarate Neuraxpharm, a treatment for relapsing remitting multiple sclerosis (RRMS). This approval was granted on 22 April 2024, under the standard expedited pathway. The medicine is indicated for adult and paediatric patients aged 13 years and older with RRMS.

Read official source →

Tecfidera in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in European Union

Frequently asked questions

Is Tecfidera approved in European Union?

Yes. EMA authorised it on 24 March 2022; EMA authorised it on 13 May 2022; EMA authorised it on 13 May 2022.

Who is the marketing authorisation holder for Tecfidera in European Union?

Sandoz GmbH holds the EU marketing authorisation.