Dimethyl fumarate Mylan

On 13 December 2023, the European Commission revoked the marketing authorisation of Dimethyl fumarate Mylan (dimethyl fumarate) in the European Union (EU). Dimethyl fumarate Mylan was a generic medicine of Tecfidera. The marketing authorisation holder for the medicine was Mylan Ireland Limited. 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 Mylan 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 Mylan 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 Mylan was granted marketing authorisation in the EU on 13 May 2022 for treatment of relapsing remitting multiple sclerosis (RRMS). Following a new application by the company, a marketing authorisation was granted by the European Commission on 22 April 2024.