Pharma Focus Europe

European Commission Revokes Generic Marketing Permissions for Dimethyl Fumarate (DMF), Including Dimethyl Fumarate Neuraxpharm

Thursday, December 21, 2023

Neuraxpharm Group, a leading European pharmaceutical company specializing in the treatment of central nervous system (CNS) disorders, has been informed by the European Commission that it will revoke all centrally granted generic marketing authorizations for dimethyl fumarate (DMF), including Dimethyl Fumarate Neuraxpharm.

The decision is based on a disputed legal interpretation stemming from a judgment against generic manufacturers by the Court of Justice of the European Union. This decision contradicts the European Medicines Agency's previous unconditional marketing authorization to Neuraxpharm in 2022 following its scientific review.

It is important to note that the decision is not linked to any public health concerns regarding generic DMF products, and the Commission has not issued a recall for these products. However, Neuraxpharm will refrain from introducing further Dimethyl Fumarate Neuraxpharm to the market until the situation is resolved.

Neuraxpharm plans to swiftly challenge this decision at the General Court of the European Union with the goal of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.

Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, strongly disagrees with the Commission's decision, emphasizing its adverse effects on competition and the denial of cost-effective treatment to patients. He underscores Neuraxpharm's dedication to providing affordable, high-quality medication to patients in the European Union, including those who rely on more economical generic versions such as Dimethyl Fumarate Neuraxpharm.



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