Dimethyl fumarate 30 mg and 120 mg Teva, gastric acid resistant tablets - public assessment report refusal of application

This involved an application procedure for a gastric acid resistant tablet with a known active ingredient, dimethyl fumarate. The legal foundation for this application is article 10a of Directive 2001/83/EC. It is claimed that the substance has been used extensively for a period exceeding 10 years (well-established use). The indication for which the application was submitted was psoriasis. The MEB deemed this application unacceptable, because the efficacy/risks ratio could not be determined. “Well-established use” has not been demonstrated sufficiently for this product, which contains only dimethyl fumarate as active ingredient. The decentralised procedure was completed with a negative outcome on 1 July 2014.