Medicine
Defitelio 80 mg/mL injection
Defitelio 80 mg/mL injection is a prescription medicine containing Defibrotide for intravenous use, marketed by Jazz Pharmaceuticals, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store DEFITELIO (defibrotide sodium) injection at 20°C-25°C (68°F-77°F)…
Key facts
- Active ingredient (INN)
- Defibrotide
- Brand
- Defitelio
- Strength
- 80 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 mL
- Marketing authorisation holder
- Jazz Pharmaceuticals
- Manufacturer
- Jazz Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store DEFITELIO (defibrotide sodium) injection at 20°C-25°C (68°F-77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AX01 Defibrotide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 March 2016
- Identifiers
- RxCUI 1746527, 1746532DailyMed set ID 2c3db989-d7ad-41ed-9ebf-698dcf6c24ecNDC 68727-800Application NDA208114
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 |
|---|---|---|---|
| 25 mL in 1 carton | 68727-800-02 | Jazz Pharmaceuticals | 30 March 2016 |
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 Defibrotide
Clinical summary
Defibrotide is a prescription medicine indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). MedsAcross supplies Defibrotide 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 DefibrotideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DEFITELIO prescribing information (Jazz Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Defitelio: European public assessment report (EPAR) · European Medicines Agency
Need Defitelio 80 mg/mL 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.