Dimethyl fumarate Mylan

Withdrawn

This medicine's authorisation has been withdrawn

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This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works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

Reference Number: EMEA/H/C/005956

Dimethyl fumarate Mylan : EPAR - Risk management plan summary

Product information

Dimethyl fumarate Mylan : EPAR - Product Information

13/12/2023

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Dimethyl fumarate Mylan : EPAR - All authorised presentations

Product details

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

Authorisation details

• EMA product number:
  EMEA/H/C/005956
• 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:
  Mylan Ireland Limited

  Unit 35/36; Grange Parade; Baldoye; Industrial Estate; Dublin 13; Ireland

• Opinion adopted:
  24/02/2022
• Marketing authorisation issued:
  13/05/2022
• Withdrawal of marketing authorisation:
  13/12/2023
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Dimethyl fumarate Mylan : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

CHMP summary of opinion for Dimethyl fumarate Mylan

Dimethyl fumarate Mylan : EPAR - Public Assessment Report