Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in April 2015 on request of the Sponsor.

On 27 October 2011, orphan designation (EU/3/11/915) was granted by the European Commission to Abbott Laboratories, United Kingdom, for 1-(4-{4-amino-7-[1-(2-hydroxyethyl)-1H- pyrazol-4-yl]thieno[3,2-c]pyridin-3-yl}phenyl)-3-(3-fluorophenyl)urea for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to AbbVie Ltd, United Kingdom, in January 2013.

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

Key facts

Active substance
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
Orphan decision number

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

AbbVie Ltd
Abbott House
Vanwall Business Park
Vanwall Road
Berks SL6 4XE
United Kingdom
Tel. +44 (0)1628 644501
Fax +44 (0)1628 672624

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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