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On 27 June 2016, orphan designation (EU/3/16/1673) was granted by the European Commission to FGK Representative Service Ltd, United Kingdom, for pyridoxine and L-pyroglutamic acid (the combination is also called metadoxine) for the treatment of fragile X syndrome.

Key facts

Active substance
Pyridoxine and L-pyroglutamic acid
Disease / condition
Treatment of fragile X syndrome
Date of first decision
EU designation number

Sponsor's contact details

FGK Representative Service Ltd.
c/o EMW, Seebeck House
1 Seebeck Place
Knowlhill, Milton Keynes
Buckinghamshire MK5 8FR
United Kingdom
Tel. +44 (0)20 3769 0905
Fax +44 (0)33 0808 0587

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.

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