EU/3/19/2148

About

On 1 April 2019, orphan designation (EU/3/19/2148) was granted by the European Commission to Takeda Pharma A/S, Denmark, for 4-hydroxy-6-{2-[4-(trifluoromethyl)phenyl]ethyl}pyridazin-3(2H)-one (also known as TAK-831) for the treatment of Friedreich’s ataxia.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2019 on request of the Sponsor.

Key facts

Active substance
4-hydroxy-6-{2-[4-(trifluoromethyl)phenyl]ethyl}pyridazin-3(2H)-one
Disease / condition
Treatment of Friedreich’s ataxia
Date of first decision
01/04/2019
Outcome
Withdrawn
EU designation number
EU/3/19/2148

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

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark
Tel. +45 46 77 1036
E-mail: info@takeda.dk

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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