Yondelis
trabectedin
Table of contents
Overview
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.
Authorisation details
Product details | |
---|---|
Name |
Yondelis
|
Agency product number |
EMEA/H/C/000773
|
Active substance |
trabectedin
|
International non-proprietary name (INN) or common name |
trabectedin
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01CX01
|
Publication details | |
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Marketing-authorisation holder |
Pharma Mar S.A.
|
Revision |
25
|
Date of issue of marketing authorisation valid throughout the European Union |
17/09/2007
|
Contact address |
Product information
24/09/2020 Yondelis - EMEA/H/C/000773 - A20/0060
Contents
- 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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Pharmacotherapeutic group
Antineoplastic agents
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.