Medicine
Yondelis 0.05 mg/mL powder for injection
Yondelis 0.05 mg/mL powder for injection is a prescription medicine containing Trabectedin for intravenous use, marketed by Janssen Products, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store YONDELIS vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F).
Key facts
- Active ingredient (INN)
- Trabectedin
- Brand
- Yondelis
- Strength
- 0.05 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 20 mL
- Marketing authorisation holder
- Janssen Products
- Manufacturer
- Janssen Products
- Origin register
- US FDA, United States
- Storage
- Store YONDELIS vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01CX01 Trabectedin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 October 2015
- Identifiers
- RxCUI 1718589, 1718594DailyMed set ID 472bd78e-be17-4b9d-90f4-9482c3aec9ffNDC 59676-610Application NDA207953
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 20 mL in 1 vial, single-use | 59676-610-01 | Janssen Products | 23 October 2015 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Trabectedin
Clinical summary
Trabectedin is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. It is available as injection and powder for injection for intravenous use. MedsAcross supplies Trabectedin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TrabectedinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- YONDELIS prescribing information (Janssen Products) · U.S. National Library of Medicine, DailyMed
- Yondelis: European public assessment report (EPAR) · European Medicines Agency
- Trabectedin Accord: European public assessment report (EPAR) · European Medicines Agency
Need Yondelis 0.05 mg/mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.