EU/3/16/1823: Orphan designation for the treatment of sudden sensorineural hearing loss

pioglitazone hydrochloride


On 12 January 2017, orphan designation (EU/3/16/1823) was granted by the European Commission to Regiomedica GmbH, Germany, for pioglitazone hydrochloride for the treatment of sudden sensorineural hearing loss.

Key facts

Active substance
pioglitazone hydrochloride
Medicine name
Intended use
Treatment of sudden sensorineural hearing loss
Orphan designation status
EU designation number
Date of designation
Regiomedica GmbH
Spitalstr. 22
79539 Lörrach
Tel. +49 7621 550750

Review of designation

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

Documents related to this orphan designation evaluation

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.

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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