Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1327328
Name of medicinal product: YONDELIS
Active substances:
Trabectedin
Estonian, English, Latin
ATC code: L01CX01
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 1mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Yondelis is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: January 10, 2024
Marketing authorization holder: Pharma Mar S.A. 
Marketing authorization number: EU/1/07/417 
Marketing authorization issued on: September 17, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 3, 2014
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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