EU/3/02/115: Orphan designation for the treatment of uraemic pruritus

(-)-17(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6beta-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan hydrochloride (nalfurafine)


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)
Intended use
Treatment of uraemic pruritus
Orphan designation status
EU designation number
Date of designation
Toray International Europe GmbH
Hugenottenallee 175
63263 Neu-Isenburg
Tel. +49 (0) 6102 79990

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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