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dabrafenib

Active substance: dabrafenib

TABLET, FOR SUSPENSION · DABRAFENIB MESYLATE 10 mg/1

United StatesActive

Marketing holder: Novartis Pharma Stein AG

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
RU 5
  • Дабрафениб Фармасинтез
    капсулы, 50 мг (original in Russian, GRLS)
    ЛП-№(010141)-(РГ-RU)
    Акционерное общество "Фармасинтез-Норд" (АО "Фармасинтез-Норд")
  • Дабрафениб-АМЕДАРТ
    капсулы, 50 мг (original in Russian, GRLS)
    ЛП-№(011280)-(РГ-RU)
    ООО "АМЕДАРТ"
  • Дабрафениб-Промомед
    капсулы, 50 мг (original in Russian, GRLS)
    ЛП-№(010317)-(РГ-RU)
    Общество с ограниченной ответственностью "ПРОМОМЕД РУС" (ООО "ПРОМОМЕД РУС")
  • Тафинлар®
    капсулы, 50 мг (original in Russian, GRLS)
    ЛП-002274
    Новартис Фарма АГ
  • Тафинлар® Комбо
    капсул и таблеток покрытых пленочной оболочкой набор, 50 мг+0.5 мг, (original in Russian, GRLS)
    ЛП-004295
    Новартис Фарма АГ
EU 2
  • Finlee
    dabrafenib mesilate
    EMEA/H/C/005885
    Novartis Europharm Limited
  • Tafinlar
    dabrafenib mesilate
    EMEA/H/C/002604
    Novartis Europharm Limited
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-2e4d-7507-b2bb-cb1847cf1df0,01a120c3-b034-7c53-a617-6a52475ec524,01a120c3-b1e1-721a-a8d2-4e3d9668c3f0,01a120c3-c062-7881-97b8-4205c70c6ad3;count=4 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-0127-7d40-974d-6001830e6021,01a12091-6d00-7bb1-a7aa-95fad000bdf9,01a12095-66a0-7ae5-9ed5-229cc765f633,01a12095-7074-7614-a68c-b247031f7855;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
17088-0212
Registration status
Active
Dispensing
Prescription only
Sources
  • product · openFDA NDC · 17088-0212 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 17088-0212 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 17088-0212 · Verified 2026-10-09 · open in source