EU/3/15/1543: Orphan designation for the treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes

(S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride

Overview

On 10 August 2015, orphan designation (EU/3/15/1543) was granted by the European Commission to Khondrion BV, the Netherlands, for (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for the treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes.

Key facts

Active substance
(S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride
Intented use
Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Orphan designation status
Positive
EU designation number
EU/3/15/1543
Date of designation
10/08/2015
Sponsor
Khondrion BV
Philips van Leydenlaan 15
6525 Nijmegen
The Netherlands
Tel. +31 243617505
E-mail: info@khondrion.com

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:

  • 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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