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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in July 2008 on request of the sponsor.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Withdrawn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