Dimethyl fumarate Polpharma

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This medicine's authorisation has been revoked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 Polpharma (dimethyl fumarate) in the European Union (EU). Dimethyl fumarate Polpharma was a generic medicine of Tecfidera. The marketing authorisation holder for the medicine was Zakłady Farmaceutyczne Polpharma S.A. 

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 Polpharma 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 Polpharma 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 Polpharma was granted marketing authorisation in the EU on 13 May 2022 for treatment of relapsing remitting multiple sclerosis (RRMS). 

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Assessment Report (EPAR) for Dimethyl fumarate Polpharma is updated to indicate that the marketing authorisation is no longer valid.

Dimethyl fumarate Polpharma : EPAR - Medicine Overview

Reference Number: EMA/127784/2022

Dimethyl fumarate Polpharma : EPAR - Risk management plan summary

Product information

Dimethyl fumarate Polpharma : EPAR - Product Information

Dimethyl fumarate Polpharma : EPAR - All authorised presentations

Product details

• Name of medicine:
  Dimethyl fumarate Polpharma
• 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 Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Authorisation details

• EMA product number:
  EMEA/H/C/005955
• 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:
  Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.

  Ul. Pelplinska 19; 83-200 Starogard; Gdanski; Poland

• 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 Polpharma : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

CHMP summary of opinion for Dimethyl fumarate Polpharma

Adopted

Dimethyl fumarate Polpharma : EPAR - Public Assessment Report