YONDELIS Powder for concentrate for solution for infusion Ref.[9078] Active ingredients: Trabectedin

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Pharma Mar, S.A., Avda. de los Reyes 1, Polรญgono Industrial La Mina, 28770, Colmenar Viejo (Madrid), Spain

Product name and form

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.

Qualitative and quantitative composition

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
Potassium dihydrogen phosphate
Phosphoric acid (for pH-adjustment)
Potassium hydroxide (for pH-adjustment)

Pack sizes and marketing

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.

Marketing authorization holder

Pharma Mar, S.A., Avda. de los Reyes 1, Polรญgono Industrial La Mina, 28770, Colmenar Viejo (Madrid), Spain

Marketing authorization dates and numbers

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

Drugs

Drug Countries
YONDELIS Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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