Namuscla

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mexiletine hcl

Authorised
This medicine is authorised for use in the European Union.

Overview

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. 

This EPAR was last updated on 30/08/2019

Authorisation details

Product details
Name
Namuscla
Agency product number
EMEA/H/C/004584
Active substance
mexiletine hcl
International non-proprietary name (INN) or common name
mexiletine hcl
Therapeutic area (MeSH)
Myotonic Disorders
Anatomical therapeutic chemical (ATC) code
C01BB02
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Lupin Europe GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
18/12/2018
Contact address

Hanauer Landstraße 139-143
60314 Frankfurt am Main
Germany

Product information

17/07/2019 Namuscla - EMEA/H/C/004584 - IAIN/0001/G

Contents

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Pharmacotherapeutic group

CARDIAC THERAPY

Therapeutic indication

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

Assessment history

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