On 17 February 2016, orphan designation (EU/3/16/1617) was granted by the European Commission to Abbvie Ltd., United Kingdom, for venetoclax for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to AbbVie Deutschland GmbH & Co. KG, Germany, in May 2018.

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in March 2019 on request of the Sponsor.

Key facts

Active substance
Disease / condition
Treatment of acute myeloid leukaemia
Date of first decision
EU designation 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 Deutschland GmbH & Co. KG
67061 Ludwigshafen am Rhein
Tel. +49 621 589 3382

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.

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