Medicine
Rivfloza 80 mg/0.5 mL injection
Rivfloza 80 mg/0.5 mL injection is a prescription medicine containing Nedosiran for subcutaneous use, marketed by Novo Nordisk, 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 2°C to 8°C (36°F to 46°F). Do not freeze. Table 4…
Key facts
- Active ingredient (INN)
- Nedosiran
- Brand
- Rivfloza
- Strength
- 80 mg/0.5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 0.5 mL
- Marketing authorisation holder
- Novo Nordisk
- Manufacturer
- Novo Nordisk
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Table 4: Storage Conditions for RIVFLOZA Refrigerated 2°C to 8°C (36°F to 46°F) Room Temperature at 15°C to 30°C (59°F to 86°F) RIVFLOZA Until expiration date Maximum 28 days (4 weeks) Store in original carton, away from direct heat… RIVFLOZA can be stored, if needed, at 15°C to 30°C (59°F to 86°F) for a maximum of 28 days (4 weeks).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 February 2024
- Identifiers
- RxCUI 2675303, 2675309, 2675312 +3DailyMed set ID ace9d4bc-4d20-4beb-9e9d-888690424833NDC 0169-5308Application NDA215842
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 in 1 carton / .5 mL in 1 vial | 0169-5308-01 | Novo Nordisk | 19 February 2024 |
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 29 September 2023 | 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
Other strengths and forms of Nedosiran
Clinical summary
Nedosiran is a prescription medicine indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., among other approved uses. MedsAcross supplies Nedosiran 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 NedosiranFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RIVFLOZA prescribing information (Novo Nordisk) · U.S. National Library of Medicine, DailyMed
Need Rivfloza 80 mg/0.5 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.