Medicine
Unituxin 17.5 mg/5 mL injection
Unituxin 17.5 mg/5 mL injection is a prescription medicine containing Dinutuximab for intravenous use, marketed by United Therapeutics, 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 Unituxin vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the…
Key facts
- Active ingredient (INN)
- Dinutuximab
- Brand
- Unituxin
- Strength
- 17.5 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL
- Marketing authorisation holder
- United Therapeutics
- Manufacturer
- United Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store Unituxin vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light until time of use. Do not freeze or shake the vial.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FX06 Sacituzumab govitecan
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 March 2015
- Identifiers
- RxCUI 1606278, 1606283DailyMed set ID d66bdf0d-9d65-45de-ae5b-a58617c27492NDC 66302-014Application BLA125516
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 |
|---|---|---|---|
| 1 vial, single-dose in 1 box / 5 mL in 1 vial, single-dose | 66302-014-01 | United Therapeutics | 10 March 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
Clinical summary
Dinutuximab is a glycolipid disialoganglioside-directed antibody indicated , in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma, among other approved uses. MedsAcross supplies Dinutuximab 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 DinutuximabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Unituxin prescribing information (United Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Unituxin 17.5 mg/5 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.