Yondelis

RSS

trabectedin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 25/03/2022

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)
  • Ovarian Neoplasms
  • Sarcoma
Anatomical therapeutic chemical (ATC) code
L01CX01
Publication details
Marketing-authorisation holder
Pharma Mar S.A.
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
17/09/2007
Contact address
Polígono Industrial La Mina
Avda. de los Reyes, 1
E-28770 Colmenar Viejo (Madrid)
Spain

Product information

22/07/2021 Yondelis - EMEA/H/C/000773 - II/0063

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

Changes since initial authorisation of medicine

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