EU/3/17/1893: Orphan designation for the treatment of anti-MAG neuropathy

Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside

Overview

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Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2021 on request of the Sponsor.

Key facts

Active substance
Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside
Intended use
Treatment of anti-MAG neuropathy
Orphan designation status
Withdrawn
EU designation number
EU/3/17/1893
Date of designation
17/07/2017
Sponsor

Pharma Gateway AB
Johanneslundsvägen 2
Hammarby
194 61 Upplands Väsby
Stockholms Lan
Sweden
Tel. +46 8 590 778 00
E-mail: info@pharmagateway.eu

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

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.

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:

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