Posted by Michael Wonder on 11 Jul 2026
Lupin announces EMA approval for NaMuscla expansion for paediatric indication with new strengths
1 July 2026 - Lupin Limited (Lupin) today announced that the EMA has approved a change to the terms of marketing authorization for NaMuscla, supported by the Pediatric Investigation Plan.
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 (6–11 years, weighing at least 20 kg), adolescents (12–17 years), and adults (≥18 years) with non-dystrophic myotonic disorders.
