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Spexotras

Active substance: trametinib dimethyl sulfoxide

trametinib dimethyl sulfoxide

Centralised EU authorisationActive

Marketing holder: Novartis Europharm Limited

Verified 2026-10-09 · EMA

Analogues in other countries
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 5
  • Mekinist
    POWDER, FOR SOLUTION · TRAMETINIB DIMETHYL SULFOXIDE .05 mg/mL
    0078-1161
    Novartis Pharmaceuticals Corporation
  • Mekinist
    TABLET, FILM COATED · TRAMETINIB DIMETHYL SULFOXIDE .5 mg/1
    0078-1105
    Novartis Pharmaceuticals Corporation
  • Mekinist
    TABLET, FILM COATED · TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1
    0078-1112
    Novartis Pharmaceuticals Corporation
  • trametinib
    TABLET, FILM COATED · TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1
    17088-0128
    Novartis Pharma Stein AG
  • trametinib
    TABLET, FILM COATED · TRAMETINIB DIMETHYL SULFOXIDE .5 mg/1
    17088-0121
    Novartis Pharma Stein AG
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-f581-7682-829c-4b4f695f1395,01a12091-67aa-7bf7-bcf1-b8e272a04773,01a12091-6d08-7543-a1b6-31ad2b4108ac,01a12093-4287-7641-8787-01b4f6234e72,01a1209c-e1b6-7801-9f9a-07f4f4b85284;count=5 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/005886
Registration status
Active
ATC code
L01EE01
Sources
  • product · EMA · EMEA/H/C/005886 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/005886 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/005886 · Verified 2026-10-09