Medicine
Kepivance 5.16 mg/1.2 mL powder for injection
Kepivance 5.16 mg/1.2 mL powder for injection is a prescription medicine containing Palifermin for intravenous use, marketed by Swedish Orphan Biovitrum AB (publ), 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 Kepivance vials in the dispensing pack in its carton refrigerated at 2°…
Key facts
- Active ingredient (INN)
- Palifermin
- Brand
- Kepivance
- Strength
- 5.16 mg/1.2 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 3 vials
- Marketing authorisation holder
- Swedish Orphan Biovitrum AB (publ)
- Manufacturer
- Swedish Orphan Biovitrum AB (publ)
- Origin register
- US FDA, United States
- Storage
- Store Kepivance vials in the dispensing pack in its carton refrigerated at 2° to 8°C (36° to 46°F) until time of use. Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V03AF08 Palifermin
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 August 2023
- Identifiers
- RxCUI 2643434, 2643436DailyMed set ID 426f6e64-2c20-4a61-6d65-7320426f6e64NDC 66658-113Application BLA125103
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 |
|---|---|---|---|
| 3 vial, single-use in 1 carton / 1.2 mL in 1 vial, single-use | 66658-113-03 | Swedish Orphan Biovitrum AB (publ) | 4 August 2023 |
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
Palifermin is a mucocutaneous epithelial cell growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. MedsAcross supplies Palifermin 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 PaliferminFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- KEPIVANCE prescribing information (Swedish Orphan Biovitrum AB (publ)) · U.S. National Library of Medicine, DailyMed
Need Kepivance 5.16 mg/1.2 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.