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Gilotrif

Active substance: afatinib

TABLET, FILM COATED · AFATINIB 30 mg/1

United StatesActive

Marketing holder: Boehringer Ingelheim Pharmaceuticals, 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
  • Giotrif
    afatinib
    EMEA/H/C/002280
    Boehringer Ingelheim International GmbH
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208f-1931-74ed-ab11-5d948b1ee800,01a12095-25c2-7842-8c44-921d76cd3ebc,01a12097-64cf-773f-a320-112a18369610;count=3 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
0597-0137
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 0597-0137 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 0597-0137 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 0597-0137 · Verified 2026-10-09 · open in source