Medicine
Betaseron kit
Betaseron kit is a prescription medicine containing Interferon beta-1b, marketed by Bayer HealthCare 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. Store BETASERON vials between 36°F to 86°F (2°C to 30°C)…
Key facts
- Active ingredient (INN)
- Interferon beta-1b
- Brand
- Betaseron
- Dosage form
- Kit
- Packs
- 5 cartons, 1 carton, 14 cartons and 1 more
- Marketing authorisation holder
- Bayer HealthCare Pharmaceuticals
- Manufacturer
- Bayer HealthCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store BETASERON vials between 36°F to 86°F (2°C to 30°C). Storage BETASERON and the diluent are for single-dose only. After reconstitution, if not used immediately, refrigerate the reconstituted solution and use within three hours.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L03AB08 Interferon beta-1b
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 July 2009
- Identifiers
- RxCUI 198360, 207059DailyMed set ID 66311f74-0472-4fa3-848a-06002ca0def5NDC 50419-524Application BLA103471
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 carton in 1 box / 1 kit in 1 carton * 1 mL in 1 vial, single-use * 1.2 mL in 1 syringe | 50419-524-05 | Bayer HealthCare Pharmaceuticals | 11 August 2009 |
| 1 carton in 1 box / 1 kit in 1 carton * 1 mL in 1 vial, single-use * 1.2 mL in 1 syringe | 50419-524-09 | Bayer HealthCare Pharmaceuticals | 11 August 2009 |
| 14 carton in 1 box / 1 kit in 1 carton * 1 mL in 1 vial, single-use * 1.2 mL in 1 syringe | 50419-524-35 | Bayer HealthCare Pharmaceuticals | 11 August 2009 |
| 14 carton in 1 box / 1 kit in 1 carton * 1 mL in 1 vial, single-use * 1.2 mL in 1 syringe | 50419-524-81 | Bayer HealthCare Pharmaceuticals | 1 September 2016 |
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
Clinical summary
Interferon beta-1b is a prescription medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is available as kits. MedsAcross supplies Interferon beta-1b 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 Interferon beta-1bFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Betaseron prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Betaferon: European public assessment report (EPAR) · European Medicines Agency
Need Betaseron kit 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.