EU/3/12/1057: Orphan designation for the treatment of cutaneous T-cell lymphoma

Naloxone hydrochloride dihydrate


On 8 November 2012, orphan designation (EU/3/12/1057) was granted by the European Commission to Winston Laboratories Ltd, United Kingdom, for naloxone hydrochloride dihydrate for the treatment of cutaneous T-cell lymphoma.

Key facts

Active substance
Naloxone hydrochloride dihydrate
Intended use
Treatment of cutaneous T-cell lymphoma
Orphan designation status
EU designation number
Date of designation
Winston Laboratories Ltd
The Roothings
45 Foley Road
KT10 0LU
United Kingdom
Tel. +44 (0)1372 469086
Fax +44 (0)1372 469591

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:

  • 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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