EU/3/14/1353: Orphan designation for the treatment of myotonic disorders

Mexiletine hydrochloride


On 19 November 2014, orphan designation (EU/3/14/1353) was granted by the European Commission to Temmler Pharma GmbH & Co. KG, Germany, for mexiletine hydrochloride for the treatment of myotonic disorders.

The sponsorship was transferred to Hormosan Pharma GmbH, Germany, in October 2015, to Lupin (Europe) Limited, United Kingdom, in August 2016 and finally to Lupin Europe GmbH in May 2018.

Mexiletine hydrochloride has been authorised in the EU as Namuscla since 18 December 2018.

Key facts

Active substance
Mexiletine hydrochloride
Intended use
Treatment of myotonic disorders
Orphan designation status
EU designation number
Date of designation
Lupin Europe GmbH
Hanauer Landstraße 139-143
60314 Frankfurt am Main
Tel. +49 69 4787 333

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Namuscla at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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