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Medicine

Mekinist 0.05 mg/mL powder for oral solution

Trametinib dimethyl sulfoxide · Oral · Novartis Pharmaceuticals
Available on requestPrescription onlyUS FDA Cold chain

Mekinist 0.05 mg/mL powder for oral solution is a prescription medicine containing Trametinib dimethyl sulfoxide 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. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store refrigerated at 2°C to 8°C (36°F to 46°F). Store at 20°C to 25°C (68°F…

Key facts

Active ingredient (INN)
Trametinib dimethyl sulfoxide
Brand
Mekinist
Strength
0.05 mg/mL
Dosage form
Powder for oral solution
Route
Oral
Packs
90 mL
Marketing authorisation holder
Novartis Pharmaceuticals
Manufacturer
Novartis Pharmaceuticals
Origin register
US FDA, United States
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F). 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). Protect from moisture and light. Store in the original carton to protect from light and moisture. After reconstitution, store in the original bottle below 25°C (77°F) and do not freeze.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
16 March 2023
Identifiers
RxCUI 1425110, 1425116, 1425118 +3DailyMed set ID 0002ad27-779d-42ab-83b5-bc65453412a1NDC 0078-1161Application NDA217513

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

PackCodeLabelerMarketed since
90 mL in 1 bottle0078-1161-47Novartis Pharmaceuticals16 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 29 May 2013Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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 Trametinib dimethyl sulfoxide

Clinical summary

Trametinib dimethyl sulfoxide is a kinase inhibitor. It is available as tablets and powder for oral solution. MedsAcross supplies Trametinib dimethyl sulfoxide 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 Trametinib dimethyl sulfoxide

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

Data sources

Need Mekinist 0.05 mg/mL powder for oral solution 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.