Yondelis

Refused

This medicine has been refused authorisation

trabectedin

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. 

CHMP summary of negative opinion for Yondelis

Adopted Reference Number: CPMP/5706/03

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