Medicine
Tafinlar 10 mg tablet for oral suspension
Tafinlar 10 mg tablet for oral suspension is a prescription medicine containing Dabrafenib for oral use, marketed by Novartis 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 at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Dabrafenib
- Brand
- Tafinlar
- Strength
- 10 mg
- Dosage form
- Tablet for oral suspension
- Route
- Oral
- Packs
- 210 tablets
- Marketing authorisation holder
- Novartis Pharmaceuticals
- Manufacturer
- Novartis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store and dispense in the original bottle with the desiccant.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EC02 Dabrafenib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 March 2023
- Identifiers
- RxCUI 1424916, 1424918, 1425228 +3DailyMed set ID fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdeaNDC 0078-1154Application NDA217514
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 tablet, for suspension in 1 bottle | 0078-1154-21 | Novartis Pharmaceuticals | 16 March 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 Dabrafenib
Clinical summary
Dabrafenib is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test, among other approved uses. MedsAcross supplies Dabrafenib 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 DabrafenibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tafinlar prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Finlee: European public assessment report (EPAR) · European Medicines Agency
- Tafinlar: European public assessment report (EPAR) · European Medicines Agency
Need Tafinlar 10 mg tablet for oral suspension 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.