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YONDELIS (Specialised Therapeutics Pharma Pty Ltd)
Product name
YONDELIS
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
trabectedin
Registration type
NCE/NBE
Indication
YONDELIS (powder for injection) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.