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Lazcluze

Active substance: lazertinib

lazertinib mesilate monohydrate

Centralised EU authorisationActive

Marketing holder: Janssen Cilag International NV

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 2
  • LAZCLUZE
    TABLET, FILM COATED · LAZERTINIB 80 mg/1
    57894-080
    Janssen Biotech, Inc.
  • LAZCLUZE
    TABLET, FILM COATED · LAZERTINIB 240 mg/1
    57894-240
    Janssen Biotech, Inc.
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208e-833e-779a-8644-70013ce088ea,01a1208f-f659-771f-b076-05f5c602ee3c;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/006074
Registration status
Active
ATC code
L01EB09
Sources
  • product · EMA · EMEA/H/C/006074 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/006074 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/006074 · Verified 2026-10-09