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EMA Approves Expanded NaMuscla Use for Myotonia Treatment

Summary

  • EMA approved new dosage strengths for NaMuscla, including 62 mg and 83 mg capsules.
  • NaMuscla's indications are revised to include symptomatic treatment of myotonia.
  • The drug is now approved for children, adolescents, and adults with myotonic disorder.

The European Medicines Agency (EMA) has authorized changes to the marketing authorization for NaMuscla, a treatment for myotonic disorder. This significant update supports the drug's expanded use across various age groups and introduces new dosage options.

The approval introduces two new capsule strengths: 62 mg and 83 mg, which will be available alongside the existing 167 mg formulation. These changes are part of a revised indication for NaMuscla, focusing on the symptomatic treatment of myotonia.

NaMuscla is now indicated for children aged 6 to 11 years who weigh at least 20 kg, as well as for adolescents and adults. This expanded access aims to provide improved symptomatic relief for individuals diagnosed with non-dystrophic myotonic disorder.

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