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 (PDF/312.9 KB)Adopted
First published: 20/11/2003
Last updated: 20/11/2003
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Pharma Mar S.A.
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