EU/3/05/268: Orphan designation for the treatment of renal-cell carcinoma

(Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in July 2008 on request of the sponsor.

On 10 March 2005, orphan designation (EU/3/05/268) was granted by the European Commission to Pfizer Limited, United Kingdom, for (Z)-N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate for the treatment of renal cell carcinoma.

(Z)-N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate has been authorised in the EU as Sutent since 19 July 2006 for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC) after failure of interferon alfa or interleukin-2 therapy.

Key facts

Active substance
(Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccinate
Medicine name
Sutent
Intended use
Treatment of renal-cell carcinoma
Orphan designation status
Withdrawn
EU designation number
EU/3/05/268
Date of designation
10/03/2005
Sponsor
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Tel. +44 (0)1304 616 161
Fax +44 13 04 65 50 47
E-mail: orphan_enquiries@pfizer.com

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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