🇪🇺 Namuscla in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EMA authorised Namuscla on 18 December 2018

Marketing authorisation

EMA — authorised 18 December 2018

Application: EMEA/H/C/004584
Marketing authorisation holder: Lupin Europe GmbH
Local brand name: Namuscla
Indication: Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
Pathway: orphan
Status: approved

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Other Other approved in European Union

Frequently asked questions

Is Namuscla approved in European Union?

Yes. EMA authorised it on 18 December 2018.

Who is the marketing authorisation holder for Namuscla in European Union?

Lupin Europe GmbH holds the EU marketing authorisation.