Tecfidera kit is a prescription medicine containing Dimethyl, marketed by Biogen, 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 15°C to 30°C (59 to 86°F). Store in original container.
Key facts
- Active ingredient (INN)
- Dimethyl
- Brand
- Tecfidera
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Biogen
- Manufacturer
- Biogen
- Origin register
- US FDA, United States
- Storage
- Store at 15°C to 30°C (59 to 86°F). Store in original container.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AX07 Dimethyl
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 March 2013
- Identifiers
- RxCUI 1373483, 1373489, 1373491 +3DailyMed set ID 665d7e74-036c-5f68-5b67-ab84b9b49151NDC 64406-007Application NDA204063
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 kit in 1 kit * 14 capsule in 1 bottle, plastic * 46 capsule in 1 bottle, plastic | 64406-007-03 | Biogen | 27 March 2013 |
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 Dimethyl
Clinical summary
Dimethyl 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. MedsAcross supplies Dimethyl 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 DimethylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TECFIDERA prescribing information (Biogen) · U.S. National Library of Medicine, DailyMed
- Skilarence: European public assessment report (EPAR) · European Medicines Agency
- Tecfidera: European public assessment report (EPAR) · European Medicines Agency
Need Tecfidera 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.