EU/3/06/401

About

On 28 August 2006, orphan designation (EU/3/06/401) was granted by the European Commission to ICON Clinical Research Limited, United Kingdom for N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl) ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate for the treatment of familial amyloid polyneuropathy.

The sponsorship was transferred to FoldRx Pharmaceuticals Limited, United Kingdom, in September 2009 and to Pfizer Limited, United Kingdom, in May 2012.

N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl) ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate has been authorised in the EU as Vyndaqel since 16 November 2011.

The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in July 2018.

This medicine is now known as tafamidis. 

Key facts

Active substance
N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate (tafamidis)
Medicine name
Vyndaqel
Disease / condition
Treatment of familial amyloid polyneuropathy
Date of first decision
28/08/2006
Outcome
Positive
EU designation number
EU/3/06/401

Review of designation

Sponsor's contact details

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium
E-mail: orphan_enquiries@pfizer.com

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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