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 02/07/2018

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Pharma Mar S.A.
Revision
23
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

25/06/2018 Yondelis - EMEA/H/C/000773 - PSUSA/00003001/201709

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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