Posted by Michael Wonder on 02 Sep 2020
Namuscla is granted a temporary subsidy
1 September 2020 - TLV has decided that Namuscla 167 mg capsules will be included in the high-cost protection until the ordinary subsidy application has been examined. The temporary subsidy covers patients who are already being treated with mexiletine under license.
Namuscla (mexiletine) was approved on 18 December 2018 by the EMA for the treatment of adult patients with symptomatic myotonia with non-dystrophic myotonic disorders.
Medicines with mexiletine as the active substance have previously been prescribed under a so-called license in Sweden. With the European approval of Namuscla, these medicines can no longer be licensed.
The company that markets Namuscla applied to the TLV in May 2020 for a subsidy.
