Is Trabectedin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Trabectedin, including YONDELIS 1 mg powder for concentrate for solution for infusion (1 mg, Powder for concentrate for solution for infusion, SAR 9479.60).

Is Trabectedin approved by the US FDA?

Drugs@FDA lists 2 application product lines for Trabectedin, including YONDELIS (Prescription); EVDI (Prescription).

Is Trabectedin authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Trabectedin: Yondelis, Trabectedin Accord.

Are there safety signals or safety updates for Trabectedin?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2025-12-23).

Active substance

Trabectedin

SFDA 1
US FDA 2
EMA 3
Health Canada 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
YONDELIS 1 mg powder for concentrate for solution for infusion	1 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 9479.60	NCE · Prescription	Pharma Mar S.A	Valid

Indications — CHI Daman Drug Formulary

SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
YONDELIS	1MG/VIAL	powder · intravenous	JANSSEN PRODS	Prescription	23 Oct 2015
EVDI	1MG/20ML (0.05MG/ML)	solution · intravenous	APOTEX	Prescription	1 May 2026

EMA European Union — centrally authorised medicines

Yondelis Pharma Mar S.A. · Authorised · authorised 17 Sep 2007 · ATC L01CX01

Therapeutic indication (EMA)

Yondelis is indicated for the treatment of 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.

Trabectedin Accord Accord Healthcare S.L.U. · Authorised · authorised 25 Apr 2025 · ATC L01CX01

Therapeutic indication (EMA)

Trabectedin Accord 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. Trabectedin Accord in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.

Yondelis Pharma Mar S.A. · Refused · ATC L01CX01

Therapeutic indication (EMA)

Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, having failed antracyclines and ifosfamide, or having failed ifosfamide and unsuitable to receive antracyclines/ifosfamide.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
YONDELIS	02351528	1 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	VALEO PHARMA INC

Safety signals and safety-related labeling changes

US FDA 23 Dec 2025 YONDELIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Sep 2015 PRAC signal: Capillary leak syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 10 Apr 2015 PRAC signal: Capillary leak syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 4 Dec 2014 PRAC signal: Capillary leak syndrome
Action for MAH: update of the product information: No

All safety entries for trabectedin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.