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EMA Product

Namuscla

Product approved by European Medicines Agency (EU)

Basic Information

Namuscla

Regulatory Information

EMEA/H/C/004584

Authorised

December 18, 2018

October 18, 2018

6

February 22, 2023

Company Information

Germany

Hanauer Landstraße 139-143 60314 Frankfurt am Main

Lupin Europe GmbH

Drug Classification

Orphan Medicine

Active Ingredients

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

Overview Summary

Namuscla is a medicine used to treat symptoms of myotonia (muscle stiffness) in patients with non-dystrophic myotonic disorders, a group of inherited muscle disorders. Non-dystrophic means no muscle wasting occurs in patients affected by the condition. Patients with non-dystrophic myotonic disorders experience muscle stiffness and pain because their muscles are slow to relax after contraction. Myotonic disorders are rare, and Namuscla was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 November 2014.

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