Medicine
Stivarga 40 mg tablet
Stivarga 40 mg tablet is a prescription medicine containing Regorafenib for oral use, 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
Store STIVARGA at 25°C (77°F), excursions are permitted from 15 to 30°C (59 to…
Key facts
- Active ingredient (INN)
- Regorafenib
- Brand
- Stivarga
- Strength
- 40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 210 bottles, 3 bottles, 1 bottle and 1 more
- Marketing authorisation holder
- Bayer HealthCare Pharmaceuticals
- Manufacturer
- Bayer HealthCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store STIVARGA at 25°C (77°F), excursions are permitted from 15 to 30°C (59 to 86°F). Store tablets in the original bottle and do not remove the desiccant.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EX05 Regorafenib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 September 2012
- Identifiers
- RxCUI 1312402, 1312408DailyMed set ID 824f19c9-0546-4a8a-8d8f-c4055c04f7c7NDC 50419-171Application NDA203085
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 |
|---|---|---|---|
| 210 bottle in 1 box / 28 tablet, film coated in 1 bottle | 50419-171-00 | Bayer HealthCare Pharmaceuticals | 27 September 2012 |
| 3 bottle, plastic in 1 box / 28 tablet, film coated in 1 bottle, plastic | 50419-171-03 | Bayer HealthCare Pharmaceuticals | 27 September 2012 |
| 1 bottle, plastic in 1 carton / 28 tablet, film coated in 1 bottle, plastic | 50419-171-04 | Bayer HealthCare Pharmaceuticals | 27 September 2012 |
| 4 bottle, plastic in 1 carton / 21 tablet, film coated in 1 bottle, plastic | 50419-171-06 | Bayer HealthCare Pharmaceuticals | 1 May 2021 |
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
Regorafenib is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type. MedsAcross supplies Regorafenib 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 RegorafenibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Stivarga prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Stivarga: European public assessment report (EPAR) · European Medicines Agency
Need Stivarga 40 mg tablet 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.