EU/3/10/770

About

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2014 on request of the sponsor.

On 20 September 2010, orphan designation (EU/3/10/770) was granted by the European Commission to Sanofi Aventis, France, for 1-[2-(benzo[1,2,5]thiadiazol-5-ylamino)-6-(2,6-dichloro-phenyl)-pyrido[2,3-d]pyrimidin-7-yl]-3-tert-butyl-urea for the treatment of acute myeloid leukaemia.

In October 2012, Sanofi Aventis changed name to Sanofi-Aventis Groupe.

For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.

Key facts

Active substance
1-[2-(Benzo[1,2,5]thiadiazol-5-ylamino)-6-(2,6-dichloro-phenyl)-pyrido[2,3-d]pyrimidin-7-yl]-3-tert-butyl-urea
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
20/09/2010
Outcome
Withdrawn
Orphan decision number
EU/3/10/770

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Sanofi-Aventis Groupe
54 rue de la Boétie
75008 Paris
France
Tel. +33 153 774 000
Fax +33 153 774 133
www.sanofi-aventis.com/contact/contact.asp

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.

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