Medicine
Hibsago 150 mg/1 mL injection
Hibsago 150 mg/1 mL injection is a prescription medicine containing Bepirovirsen for subcutaneous use, marketed by GlaxoSmithKline, 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 in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not…
Key facts
- Active ingredient (INN)
- Bepirovirsen
- Brand
- Hibsago
- Strength
- 150 mg/1 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 2 syringes of 1 mL
- Marketing authorisation holder
- GlaxoSmithKline
- Manufacturer
- GlaxoSmithKline
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not freeze. Following Dispensing: Store HIBSAGO at room temperature up to 86°F (30°C) for 12 weeks. Store in the original carton to protect from light. Do not shake. Do not shake.
- 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
- 20 October 2026
- Identifiers
- RxCUI 2754988, 2754994DailyMed set ID 2cca7226-d8f9-4917-8d10-83e216acf393NDC 0173-0941Application NDA221276
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 |
|---|---|---|---|
| 2 syringe in 1 carton / 1 mL in 1 syringe | 0173-0941-39 | GlaxoSmithKline | 20 October 2026 |
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 20 October 2026 | 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
Bepirovirsen is a prescription medicine indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis, among other approved uses. MedsAcross supplies Bepirovirsen 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 BepirovirsenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hibsago prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
Need Hibsago 150 mg/1 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.