On 7 October 2013, orphan designation (EU/3/13/1189) was granted by the European Commission to Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare, Italy, for mexiletine hydrochloride for the treatment of myotonic disorders.

Key facts

Active substance
Mexiletine hydrochloride
Disease / condition
Treatment of myotonic disorders
Date of first decision
EU designation number

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Agenzia Industrie Difesa-Stabilimento Chimico Farmaceutico Militare
Via XX Settembre 123/A
00187 Rome
Tel. +39 06 4990 3723
Fax +39 055 425 0568

Patients' organisations

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

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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