Medicine
Beyfortus 100 mg/1 mL injection
Beyfortus 100 mg/1 mL injection is a prescription medicine containing Nirsevimab for intramuscular use, marketed by Sanofi Vaccines, 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 between 36°F to 46°F (2°C to 8°C). After removal from the…
Key facts
- Active ingredient (INN)
- Nirsevimab
- Brand
- Beyfortus
- Strength
- 100 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 5 syringes of 1 mL, 1 syringe of 1 mL
- Marketing authorisation holder
- Sanofi Vaccines
- Manufacturer
- Sanofi Vaccines
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 36°F to 46°F (2°C to 8°C). After removal from the refrigerator, BEYFORTUS must be used within 48 hours or discarded. Do not freeze. BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 48 hours. Store BEYFORTUS in original carton to protect from light until time of use. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J06BD08 Nirsevimab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 July 2023
- Identifiers
- RxCUI 2642406, 2642412, 2642414 +1DailyMed set ID 2f08fa60-f674-432d-801b-1f9514bd9b39NDC 49281-574Application BLA761328
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 |
|---|---|---|---|
| 5 syringe in 1 carton / 1 mL in 1 syringe | 49281-574-15 | Sanofi Vaccines | 18 July 2023 |
| 1 syringe in 1 carton / 1 mL in 1 syringe | 49281-574-88 | Sanofi Vaccines | 18 July 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
Other strengths and forms of Nirsevimab
Clinical summary
Nirsevimab is a respiratory syncytial virus anti-F protein monoclonal antibody indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. MedsAcross supplies Nirsevimab 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 NirsevimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BEYFORTUS prescribing information (Sanofi Vaccines) · U.S. National Library of Medicine, DailyMed
- Beyfortus: European public assessment report (EPAR) · European Medicines Agency
Need Beyfortus 100 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.