EU/3/16/1617

About

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.

Key facts

Active substance
Venetoclax
Disease / condition
Treatment of acute myeloid leukaemia
Date of decision
17/02/2016
Outcome
Positive
Orphan decision number
EU/3/16/1617

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
Knollstrasse
67061 Ludwigshafen
Tel. +49 621 589 3382
E-mail: eu-orphan-drug@abbvie.com

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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