EU/3/10/807: Orphan designation for the treatment of frontotemporal dementia with parkinsonism-17

Methylthioninium

Overview

On 26 November 2010, orphan designation (EU/3/10/807) was granted by the European Commission to Dr Hans Moebius, United Kingdom, for methylthioninium for the treatment of frontotemporal dementia with parkinsonism-17.

The sponsorship was transferred to Prof. Claude Wischik, United Kingdom, in February 2012 and subsequently to TauRx Therapeutics Europe Ltd, United Kingdom, in August 2016.

The sponsorship was transferred Pharma Gateway AB, Sweden, in March 2019.

Key facts

Active substance
Methylthioninium
Intended use
treatment of frontotemporal dementia with parkinsonism-17
Orphan designation status
Positive
EU designation number
EU/3/10/807
Date of designation
26/11/2010
Sponsor

Pharma Gateway AB
Johanneslundsvägen 2
Hammarby
194 61 Upplands Väsby
Stockholms Lan
Sweden
Tel. +46 8 590 778 00
E-mail: info@pharmagateway.eu

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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