EU/3/14/1353

About

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
Disease / condition
Treatment of myotonic disorders
Date of first decision
19/11/2014
Outcome
Positive
EU designation number
EU/3/14/1353

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 iconorphan medicine assessment report

Sponsor's contact details

Lupin Europe GmbH
Hanauer Landstraße 139-143
60314 Frankfurt am Main
Germany
Tel. +49 69 4787 333
E-mail: eu-ra@lupin.com

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;

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