EU/3/09/650

About

On 24 July 2009, orphan designation (EU/3/09/650) was granted by the European Commission to Micromet AG, Germany, for blinatumomab for the treatment of acute lymphoblastic 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.

Update: Blinatumomab (Blincyto) has been authorised in the EU since 23 November 2015 for treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia.

Key facts

Active substance
blinatumomab
Disease / condition
Treatment of acute lymphoblastic leukaemia
Date of first decision
24/07/2009
Outcome
Positive
EU designation number
EU/3/09/650

Review of designation

Sponsor's contact details

Amgen Europe BV
Minervum 7061
4817 ZK Breda
The Netherlands
Tel. +31 765732000
Fax: 31 765732001
http://www.amgen.nl/dutch/contact_us/amgen_contact.jsp

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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