Yondelis

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Refused

This medicine has been refused authorisation

trabectedin
MedicineHumanRefused
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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. 

Product details

Name of medicine
Yondelis
Active substance
trabectedin
International non-proprietary name (INN) or common name
trabectedin
Therapeutic area (MeSH)
Sarcoma
Anatomical therapeutic chemical (ATC) code
L01CX01

Pharmacotherapeutic group

Antineoplastic agents

Application details

EMA product number
EMEA/H/C/000464
Marketing authorisation applicant
Pharma Mar S.A.
Opinion adopted
20/11/2003
Refusal of marketing authorisation
07/09/2004
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