Lupin receives EMA approval for Pediatric Indication of NaMuscla

Lupin today announced that the European Medicines Agency (EMA) has approved a change to the terms of marketing authorization for NaMuscla, supported by the Pediatric Investigation Plan (PIP). The approval includes two new dosage strengths, 62 mg and 83 mg capsules, in addition to the existing 167 mg, and the revised indications that cover symptomatic treatment of myotonia in children (6?C11 years, weighing at least 20 kg), adolescents (12?C17 years), and adults (??18 years) with non-dystrophic myotonic disorder.