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Rozlytrek

Active substance: entrectinib

PELLET · ENTRECTINIB 50 mg/201

United StatesActive

Marketing holder: Genentech, 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
  • Rozlytrek
    Entrectinib
    EMEA/H/C/004936
    Roche Registration GmbH 
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-307a-715e-9b97-e86cfd3bf7bc,01a12091-b662-7c3a-8a37-384f9425c112,01a12096-00c8-77c4-b41b-b17ecb620520;count=3 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
50242-623
Registration status
Active
Dispensing
Prescription only
Route
ORAL
Sources
  • product · openFDA NDC · 50242-623 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 50242-623 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 50242-623 · Verified 2026-10-09 · open in source