Basic Information
Yondelis
Regulatory Information
EMEA/H/C/000773
September 17, 2007
28
March 25, 2022
Company Information
Spain
Polígono Industrial La Mina Avda. de los Reyes, 1 E-28770 Colmenar Viejo (Madrid)
PHARMA MAR SA
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Yondelis. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Yondelis.