EU/3/03/176: Orphan designation for the treatment of chronic lymphocytic leukaemia

Recombinant antibody derivative against human CD19 and CD3 (blinatumomab)

Table of contents


This medicine is now known as blinatumomab.

On 1 December 2003, orphan designation (EU/3/03/176) was granted by the European Commission to Micromet AG, Germany, for recombinant antibody derivative against human CD19 and CD3 for the treatment of chronic lymphocytic leukaemia.

In January 2012, Micromet AG changed name to Micromet GmbH. In May 2012, Micromet GmbH changed name to Amgen Research (Munich) GmbH.

The sponsorship was transferred to Amgen Europe BV, The Netherlands, in February 2014.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in December 2020 on request of the Sponsor.

Key facts

Active substance
Recombinant antibody derivative against human CD19 and CD3 (blinatumomab)
Intended use
Treatment of chronic lymphocytic leukaemia
Orphan designation status
EU designation number
Date of designation

Amgen Europe BV
Minervum 7061
4817 ZK Breda
The Netherlands
Tel. +31 765732000

Documents related to this orphan designation evaluation

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:

How useful was this page?

Add your rating