Yondelis

RSS

trabectedin

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 24 July 2003 the Committee for Proprietary Medicinal Products (CPMP) adopted a negative opinion, recommending not to grant a marketing authorisation for the medicinal product Yondelis, 0.25 mg and 1 mg, powder for concentrate for solution for infusion intended for patients with advanced soft tissue sarcoma (STS), having failed anthracyclines and ifosfamide, or having failed ifosfamide and unsuitable to receive anthracyclines. Yondelis was designated as an orphan medicinal product on 30 May 2001 (EU/3/01/039). The applicant for this medicinal product is Pharma Mar S.A. 

This EPAR was last updated on 20/11/2003

Application details

Product details
Name
Yondelis
Active substance
trabectedin
International non-proprietary name (INN) or common name
trabectedin
Therapeutic area (MeSH)
Sarcoma
Anatomical therapeutic chemical (ATC) code
L01CX01
Application details
Marketing-authorisation applicant
Pharma Mar S.A.
Date of opinion
20/11/2003
Date of refusal of marketing authorisation
07/09/2004

Assessment history

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