YONDELIS

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

The drug YONDELIS contains one active pharmaceutical ingredient (API):

1
UNII ID0YZQ2TCP - 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.

 
Read more about Trabectedin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 YONDELIS Powder for concentrate for solution for infusion MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L01CX01 Trabectedin L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01C Plant alkaloids and other natural products → L01CX Other plant alkaloids and natural products
Discover more medicines within L01CX01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02351528
EE Ravimiamet 1327317, 1327328, 1847796
ES Centro de información online de medicamentos de la AEMPS 07417001, 07417002
FI Lääkealan turvallisuus- ja kehittämiskeskus 015532, 015598
FR Base de données publique des médicaments 60457338, 66602114
GB Medicines & Healthcare Products Regulatory Agency 155482, 155485
HK Department of Health Drug Office 59078
IL מִשְׂרַד הַבְּרִיאוּת 6626
IT Agenzia del Farmaco 038165015, 038165027
JP 医薬品医療機器総合機構 4291431D1027, 4291431D2023
LT Valstybinė vaistų kontrolės tarnyba 1029593, 1029594
MX Comisión Federal para la Protección contra Riesgos Sanitarios 220M2009
NL Z-Index G-Standaard, PRK 107654, 107662
PL Rejestru Produktów Leczniczych 100189891, 100313397
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W52365001, W52366001
SG Health Sciences Authority 13661P
TR İlaç ve Tıbbi Cihaz Kurumu 8699650772737
US FDA, National Drug Code 59676-610
ZA Health Products Regulatory Authority 43/26/0557

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