EU/3/17/1893

About

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)-(1à3)-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.

Key facts

Active substance
Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside
Disease / condition
Treatment of anti-MAG neuropathy
Date of first decision
17/07/2017
Outcome
Positive
EU designation number
EU/3/17/1893

Review of designation

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

Sponsor's contact details

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

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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