| Active substance | Mexiletine |
| Holder | Lupin Atlantis Holdings S.A |
| Status | Running |
| Indication | Mexiletine Prolonged Release (mexiletine-PR) for the treatment of adult Non-Dystrophic Myotonia. |
| Public documents | Approbation |
| Information for the patient | |
| Informed consent | |
| Last update | 26/06/2026 |