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.
|Disease / condition||
Treatment of myotonic disorders
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
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;