EU/3/06/424

About

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.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in March 2020 at the end of the 10-year period of market exclusivity.

Key facts

Active substance
thiotepa
Medicine name
Tepadina
Disease / condition
Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
Date of first decision
29/01/2007
Outcome
Withdrawn
EU designation number
EU/3/06/424

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.

Sponsor's contact details

ADIENNE S.r.l.S.U.
Via Galileo Galilei, 19
20867 Caponago (MB)
Italy
Tel. +39 02 4070 0445
Fax +39 02 9574 5179
E-mail: adienne@adienne.com

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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