EU/3/04/186: Orphan designation for the conditioning treatment prior to haematopoietic-progenitor-cell transplantation



On 23 February 2004, orphan designation (EU/3/04/186) was granted by the European Commission to medac Gesellschaft fuer klinische Spezialpräparate mbH, Germany, for treosulfan for the conditioning treatment prior to haematopoietic progenitor cell transplantation.

Please note that this product (marketed as Trecondi) was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in June 2019 at the time of the granting of a marketing authorisation.

This product was initially authorised as a non-orphan medicinal product. Further to the Judgment of the General Court of 23 September 2020 in Medac Gesellschaft für klinische Spezialpräparate v Commission, T-549/19, the Commission adopted an Implementing Decision on 24 November 2020, authorising the medicinal product as orphan.

Key facts

Active substance
Intended use
Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
Orphan designation status
EU designation number
Date of designation

medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6
D-22880 Wedel
Tel. + 49 4103 8006 0
Fax + 49 4103 8006 100

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Trecondi at the time of marketing authorisation, and recommended that the orphan designation should not be maintained. 
More information is available in the PDF icon orphan medicine assessment report .

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:

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