EU/3/02/115

About

This medicine is now known as nalfurafine.

On 11 September 2002, orphan designation (EU/3/02/115) was granted by the European Commission to Toray Europe Limited, United Kingdom, for (-)-17-(cyclopropylmethyl)-3,14 ß-dihydroxy-4,5 α-epoxy-6ß-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan hydrochloride (intravenous use) for the treatment of uremic pruritus.

Toray Europe Limited changed name to Toray International U.K. Limited in January 2008.

The sponsorship was transferred to Toray International Europe GmbH, Germany, in February 2017.

Key facts

Active substance
(-)-17(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6beta-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan hydrochloride (nalfurafine)
Disease / condition
Treatment of uraemic pruritus
Date of first decision
11/09/2002
Outcome
Positive
EU designation number
EU/3/02/115

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

Toray International Europe GmbH
Hugenottenallee 175
63263 Neu-Isenburg
Germany
Tel. +49 (0) 6102 79990
E-mail:  medical@toray-intl.de

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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