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Gomekli

Active substance: mirdametinib

TABLET, FOR SUSPENSION · MIRDAMETINIB 1 mg/1

United StatesActive

Marketing holder: SpringWorks Therapeutics, Inc.

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Ezmekly
    mirdametinib
    EMEA/H/C/006460
    Merck Europe B.V. 
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a12091-15c5-7e3b-9ae4-05400b54219e,01a12095-31ff-7156-bba8-8883f4aeaee5,01a12097-7d16-723f-b74d-be6ee6b7f993;count=3 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
82448-134
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 82448-134 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 82448-134 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 82448-134 · Verified 2026-10-09 · open in source