Human medicines European public assessment report (EPAR): Dimethyl fumarate Accord, dimethyl fumarate, Date of authorisation: 15/02/2023, Status: Withdrawn

Overview

Metadata

Provider: 

European Medicines Agency

URL: 

https://www.ema.europa.eu/en/medicines/human/EPAR/dimethyl-fumarate-accord

Retrieved on: 

Tuesday, January 2, 2024

Information

Tags: 

Medical Subject Headings, Marketing, European Commission, INN, Dimethyl fumarate, Multiple sclerosis, ATC, Justice, International, RRMS, Ageing, Language, Civil service commission, Select, Patient, Anatomy, Commission, Sclerosis, Accord, IIA, Judgement, Petrochemical

Geotags: 

EU

Summary

Key Points: 

• 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  This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works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 Accord : EPAR - Medicine overview
  Product information
  Dimethyl fumarate Accord : 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 Accord : EPAR - All Authorised presentations
  Product details
  - Name of medicine
  - Dimethyl fumarate Accord
  - Active substance
  - dimethyl fumarate
  - International proprietary name (INN) or common name
  - dimethyl fumarate
  - Therapeutic area (MeSH)
  - Multiple Sclerosis, Relapsing-Remitting
  - Multiple Sclerosis
  - Anatomical therapeutic chemical (ATC) code
  - L04AX07
  Pharmacotherapeutic groupImmunosuppressants
  Therapeutic 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).

Copyright: 

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