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Molecule

Dimethyl

Also known as dimethyl fumarate
Available on requestImmunology and transplant
Presentations
7
Brands
1
Manufacturers
1
Available from stock
0

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

Key facts

ATC classification
L04AX07 Dimethyl · Immunosuppressive drug, subgroup L04AX
US FDA first approval
27 March 2013
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Delayed-release capsule, Capsule, Kit
Identifiers
UNII 47U3T2FC2WCAS 81-93-6Q11697891

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

TECFIDERA is 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.

Source: US FDA prescribing information

How it works

The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.

Source: US FDA prescribing information

Dosing overview

Starting dose: 120 mg twice a day, orally, for 7 days. Maintenance dose after 7 days: 240 mg twice a day, orally. Swallow TECFIDERA capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food. Take TECFIDERA with or without food

Source: US FDA prescribing information

Contraindications

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema. Known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA.

Source: US FDA prescribing information

Warnings and precautions

Anaphylaxis and Angioedema: Discontinue and do not restart TECFIDERA if these occur. Progressive Multifocal Leukoencephalopathy (PML): Withhold TECFIDERA at the first sign or symptom suggestive of PML. Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding TECFIDERA in cases of serious infection until the infection has resolved. Lymphopenia: Obtain a CBC including lymphocyte count before initiating TECFIDERA, after 6 months, and every 6 to 12 months thereafter. Consider interruption of TECFIDERA if lymphocyte counts <0.5 x 10 9 /L persist for more than six months. Liver Injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.

Source: US FDA prescribing information

Side effects

The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema. Progressive multifocal leukoencephalopathy. Herpes Zoster and Other Serious Opportunistic Infections. Lymphopenia. Liver Injury. Flushing. Serious Gastrointestinal Reactions Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

7 presentations of Dimethyl, sorted by availability.

MedicineManufacturerRegisterAvailability
Dimethyl 240 mg delayed-release capsuleOralGeneric name—US FDAAvailable on request
Dimethyl 120 mg delayed-release capsuleOralGeneric name—US FDAAvailable on request
Dimethyl 240 mg capsuleOralGeneric name—US FDAAvailable on request
Dimethyl 120 mg capsuleOralGeneric name—US FDAAvailable on request
Tecfidera kitBiogenUS FDAAvailable on request
Tecfidera 120 mg capsuleOralBiogenUS FDAAvailable on request
Tecfidera 240 mg capsuleOralBiogenUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 March 2013Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Dimethyl available for export from India?

Yes, on request. MedsAcross lists 7 presentations of Dimethyl and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Dimethyl have?

The catalogue lists 1 brand names for Dimethyl, including Tecfidera.

Is Dimethyl approved by the US FDA?

Yes. The US FDA first approved Dimethyl on 27 March 2013, according to Drugs@FDA.

Is Dimethyl authorised in the European Union?

Yes. Dimethyl has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Dimethyl need cold chain shipping?

No listed presentation of Dimethyl is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Dimethyl in?

Dimethyl is classified under ATC code L04AX07 (Dimethyl).

References

  1. TECFIDERA prescribing information (Biogen). U.S. National Library of Medicine, DailyMed. Retrieved 4 June 2025
  2. Skilarence: European public assessment report (EPAR). European Medicines Agency. Retrieved 17 March 2025
  3. Tecfidera: European public assessment report (EPAR). European Medicines Agency. Retrieved 11 August 2026

Request Dimethyl for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.