EU/3/08/538: Orphan designation for the treatment of small cell lung cancer

Amrubicin hydrochloride

Table of contents


Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in May 2016 on request of the Sponsor.

On 2 April 2008, orphan designation (EU/3/08/538) was granted by the European Commission to Pharmion Ltd, United Kingdom, for amrubicin hydrochloride for the treatment of small-cell lung cancer.

The sponsorship was transferred to Celgene Europe Limited, United Kingdom, in December 2008.

Key facts

Active substance
Amrubicin hydrochloride
Intended use
Treatment of small cell lung cancer
Orphan designation status
EU designation number
Date of designation

Celgene Europe Limited
1 Longwalk Road
Stockley Park
Middlesex UB11 1DB
United Kingdom
Telephone: +44 208 831 83 00
Telefax: +44 208 831 83 01

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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