Medicine
Onivyde 4.3 mg/mL powder for injection
Onivyde 4.3 mg/mL powder for injection is a prescription medicine containing Irinotecan for intravenous use, marketed by Ipsen Biopharmaceuticals, 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
Do NOT freeze. Store ONIVYDE at 2ºC to 8ºC (36°F to 46°F). Protect from light.
Key facts
- Active ingredient (INN)
- Irinotecan
- Brand
- Onivyde
- Strength
- 4.3 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Ipsen Biopharmaceuticals
- Manufacturer
- Ipsen Biopharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do NOT freeze. Store ONIVYDE at 2ºC to 8ºC (36°F to 46°F). Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01CE02 Irinotecan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 October 2015
- Identifiers
- RxCUI 1719772, 1719777DailyMed set ID c8b58efa-1820-48a4-b70d-62918fc4abfcNDC 15054-0043Application NDA207793
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 carton / 10 mL in 1 vial, single-dose | 15054-0043-1 | Ipsen Biopharmaceuticals | 22 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 Irinotecan
Clinical summary
Irinotecan is a topoisomerase inhibitor indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum, among other approved uses. MedsAcross supplies Irinotecan 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 IrinotecanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Camptosar prescribing information (Pharmacia & Upjohn) · U.S. National Library of Medicine, DailyMed
- Onivyde pegylated liposomal (previously Onivyde): European public assessment report (EPAR) · European Medicines Agency
Need Onivyde 4.3 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.