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.
Treatment of fragile X syndrome
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FGK Representative Service Ltd.
c/o EMW, Seebeck House
1 Seebeck Place
Knowlhill, Milton Keynes
Buckinghamshire MK5 8FR
Tel. +44 (0)20 3769 0905
Fax +44 (0)33 0808 0587
Documents related to this orphan designation evaluation
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: