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
|