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Rozlytrek

Active substance: entrectinib

Entrectinib

Centralised EU authorisationActive

Marketing holder: Roche Registration GmbH 

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
US 3
  • Rozlytrek
    PELLET · ENTRECTINIB 50 mg/201
    50242-623
    Genentech, Inc.
  • Rozlytrek
    CAPSULE · ENTRECTINIB 200 mg/1
    50242-094
    Genentech, Inc.
  • Rozlytrek
    CAPSULE · ENTRECTINIB 100 mg/1
    50242-091
    Genentech, Inc.
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
EMEA/H/C/004936
Registration status
Active
ATC code
L01EX14
Sources
  • product · EMA · EMEA/H/C/004936 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004936 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004936 · Verified 2026-10-09