On 17 July 2017, orphan designation (EU/3/17/1893) was granted by the European Commission to SFL Regulatory Affairs Consulting Ltd, United Kingdom, for polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside for the treatment of anti-MAG neuropathy.
The sponsorship was transferred to SFL Regulatory Services GmbH, Austria, in December 2018 and subsequently to Pharma Gateway AB, Sweden, in September 2020.
Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2021 on request of the Sponsor.
Treatment of anti-MAG neuropathy
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Review of designation
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: