EU/3/01/051: Orphan designation for the treatment of systemic secondary amyloidosis

1,3-Propanedisulfonic acid, disodium salt

Table of contents


On 31 July 2001, orphan designation (EU/3/01/051) was granted by the European Commission to Quintiles Limited, United Kingdom, for 1,3-propanedisulfonic acid, disodium salt for the treatment of systemic secondary amyloidosis.

The sponsorship was transferred to Neurochem Luxco II S.A.R.L, Luxembourg on September 2005.

The sponsor changed its name to Bellus Health Luxo II S.à r.l. in February 2010.

The sponsorship was transferred to Kiacta Europe Ltd, United Kingdom, in December 2010 and subsequently to Phinco S.à r.l. in July 2013.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
1,3-Propanedisulfonic acid, disodium salt
Intended use
Treatment of systemic secondary amyloidosis
Orphan designation status
EU designation number
Date of designation
C.T. Phinco S.à.r.l.
65 Boulevard Grande Duchesse Charlotte
L-1331 Luxembourg
Tel. +352 26449639
Fax +352 26383507

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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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