EU/3/13/1184

About

This medicine is now known as rivipansel.

On 5 August 2013, orphan designation (EU/3/13/1184) was granted by the European Commission to Pfizer Limited, United Kingdom, for (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-β-D-galactopyranosyl]-4-O-(α-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide for the treatment of sickle-cell disease.

The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in November 2018.

The sponsorship was transferred to FGK Representative Service GmbH, Germany in April 2020.

Key facts

Active substance
(1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-β-D-galactopyranosyl]-4-O-(α-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide (rivipansel)
Disease / condition
Treatment of sickle cell disease
Date of first decision
05/08/2013
Outcome
Positive
EU designation number
EU/3/13/1184

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

FGK Representative Service GmbH
Heimeranstrasse 35
Schwanthalerhoehe-Laim
80339 Munich
Bavaria
Germany
Tel: +49 89 893119 38
E-mail: clinicaltrials@glycomimetics.com

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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