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.
Yondelis : EPAR - Summary for the public (PDF/107.42 KB)
First published: 07/07/2009
Last updated: 25/06/2015
Yondelis : EPAR - Risk-management-plan summary (PDF/329.4 KB)
First published: 14/04/2021
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|International non-proprietary name (INN) or common name||
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Pharma Mar S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
Polígono Industrial La Mina
Avda. de los Reyes, 1
E-28770 Colmenar Viejo (Madrid)
22/07/2021 Yondelis - EMEA/H/C/000773 - II/0063
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.