Medicine
Rolvedon 13.2 mg/0.6 mL injection
Rolvedon 13.2 mg/0.6 mL injection is a prescription medicine containing Eflapegrastim for subcutaneous use, marketed by Spectrum 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. 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 refrigerated at 36°F to 46°F (2°C to 8°C) in the carton to protect from…
Key facts
- Active ingredient (INN)
- Eflapegrastim
- Brand
- Rolvedon
- Strength
- 13.2 mg/0.6 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- .6 mL
- Marketing authorisation holder
- Spectrum Pharmaceuticals
- Manufacturers
- Spectrum PharmaceuticalsAssertio Specialty Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not freeze, discard syringe if frozen. Discard any prefilled syringe left at room temperature for greater than 72 hours. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 October 2022
- Identifiers
- RxCUI 2612541, 2612547DailyMed set ID 2dc62c46-bb10-4a62-a459-d3eeeb6dd82f, 6e436115-62e7-4729-aeb0-ff78ea685206NDC 82497-132, 76961-101Application BLA761148
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 |
|---|---|---|---|
| .6 mL in 1 syringe, glass | 76961-101-01 | Spectrum Pharmaceuticals | 18 October 2022 |
| .6 mL in 1 syringe, glass | 82497-132-01 | Assertio Specialty Pharmaceuticals | 11 December 2025 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 9 September 2022 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Eflapegrastim is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. MedsAcross supplies Eflapegrastim 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 EflapegrastimFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rolvedon prescribing information (Spectrum Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Rolvedon 13.2 mg/0.6 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.