Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770, Colmenar Viejo (Madrid), Spain
Yondelis 0.25 mg powder for concentrate for solution for infusion.
Yondelis 1 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to off-white powder. |
Yondelis 0.25 mg: Each vial of powder contains 0.25 mg of trabectedin. One ml of reconstituted solution contains 0.05 mg of trabectedin.
Excipients with known effect: Each vial of powder contains 2 mg of potassium and 0.1 g of sucrose.
For the full list of excipients, see section 6.1.
Yondelis 1 mg: Each vial of powder contains 1 mg of trabectedin. One ml of reconstituted solution contains 0.05 mg of trabectedin.
Excipients with known effect: Each vial of powder contains 8 mg of potassium and 0.4 g of sucrose.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Trabectedin |
Trabectedin binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove. This binding to DNA triggers a cascade of events affecting several transcription factors, DNA binding proteins, and DNA repair pathways, resulting in perturbation of the cell cycle. Trabectedin has been shown to exert antiproliferative in vitro and in vivo activity against a range of human tumour cell lines and experimental tumours, including malignancies such as sarcoma, breast, non-small cell lung, ovarian and melanoma. |
| List of Excipients |
|---|
|
Sucrose |
Yondelis 0.25 mg: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 0.25 mg of trabectedin. Each carton contains one vial.
Yondelis 1 mg: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 1mg of trabectedin. Each carton contains one vial.
Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770, Colmenar Viejo (Madrid), Spain
Yondelis 0.25 mg: EU/1/07/417/001
Yondelis 1 mg: EU/1/07/417/002
Date of first authorisation: 17 September 2007
Date of latest renewal: 03 August 2012
| Drug | Countries | |
|---|---|---|
| YONDELIS | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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