Medicine
Benlysta 120 mg/1.5 mL powder for injection
Benlysta 120 mg/1.5 mL powder for injection is a prescription medicine containing Belimumab for intravenous 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
Do not freeze. Prior to Dispensing Refrigerate prefilled autoinjectors and…
Key facts
- Active ingredient (INN)
- Belimumab
- Brand
- Benlysta
- Strength
- 120 mg/1.5 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- GlaxoSmithKline
- Manufacturer
- GlaxoSmithKline
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Prior to Dispensing Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C). Do not freeze. Following Dispensing Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C). Do not freeze. BENLYSTA may be stored outside of the refrigerator up to 86°F (30°C) for up to 12 hours if protected from sunlight.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AG04 Belimumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 March 2011
- Identifiers
- RxCUI 1656395, 1656398, 1656400 +5DailyMed set ID 2fa3c528-1777-4628-8a55-a69dae2381a3NDC 49401-102, 49401-101Application BLA125370
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 / 1.5 mL in 1 vial | 49401-101-01 | GlaxoSmithKline | 10 March 2011 |
| 1 vial in 1 carton / 5 mL in 1 vial | 49401-102-01 | GlaxoSmithKline | 10 March 2011 |
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 Belimumab
Clinical summary
Belimumab is a B lymphocyte stimulator-specific inhibitor indicated for the treatment of patients 5 years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy, and, among other approved uses. MedsAcross supplies Belimumab 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 BelimumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BENLYSTA prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
- Benlysta: European public assessment report (EPAR) · European Medicines Agency
Need Benlysta 120 mg/1.5 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.