On 29 January 2007, orphan designation (EU/3/06/424) was granted by the European Commission to Adienne S.r.l, Italy, to thiotepa for the conditioning treatment prior to haematopoietic progenitor cell transplantation.
In January 2014, ADIENNE S.r.l. changed name to ADIENNE S.r.l.S.U.
Thiotepa has been authorised in the EU as Tepadina since 15 March 2010.
|Disease / condition||
Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
|Date of first decision||
|EU designation number||
Review of designation
During its meeting of 5-6 January 2010, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/06/424 for Tepadina (thiotepa) as an orphan medicinal product for the conditioning treatment prior to haematopoietic progenitor cell transplantation. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained*.
* The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Tepadina (thiotepa) for the conditioning treatment prior to haematopoietic progenitor cell transplantation (PDF/128.33 KB)
First published: 11/04/2011
Last updated: 11/04/2011
Sponsor's contact details
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.