09 diciembre 2019

Yondelis // Ovario // EU . ORPHAN DESIGNATION: TRABECTEDIN, TREATMENT OF OVARIAN CANCER, , EXPIRED .

(AGENPARL) – London (United Kingdom), mer 27 novembre 2019.

At the time of designation, ovarian cancer affected approximately 2.4 in people in the European Union (EU)*. This is equivalent to a total of around people, and is below the threshold for orphan designation, which is 5 people in . This is based on the information provided by the sponsor and the knowledge of the Committee for Orphan Medicinal Products (COMP).

*Disclaimer: The number of patients affected by the condition is estimated and assessed for the purpose of the designation, for a European Community population of (Eurostat 2002) and may differ from the true number of patients affected by the condition. This estimate is based on available information and calculations presented by the sponsor at the time of the application.