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Tagrisso

Active substance: osimertinib

osimertinib mesilate

Centralised EU authorisationActive

Marketing holder: AstraZeneca AB

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 4
  • TAGRISSO
    TABLET, FILM COATED · OSIMERTINIB 40 mg/1
    0310-1248
    AstraZeneca Pharmaceuticals LP
  • TAGRISSO
    TABLET, FILM COATED · OSIMERTINIB 80 mg/1
    0310-1251
    AstraZeneca Pharmaceuticals LP
  • TAGRISSO
    TABLET, FILM COATED · OSIMERTINIB 40 mg/1
    0310-1349
    AstraZeneca Pharmaceuticals LP
  • TAGRISSO
    TABLET, FILM COATED · OSIMERTINIB 80 mg/1
    0310-1350
    AstraZeneca Pharmaceuticals LP
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208d-7161-7809-a2de-cc1a16ff47d0,01a12096-d90c-790f-8c0a-ed5933c9e147,01a12096-d934-718d-ab0b-c1a69a36d6c8,01a12096-d93e-7086-8b26-768d775f03e1;count=4 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004124
Registration status
Active
ATC code
L01XE
Sources
  • product · EMA · EMEA/H/C/004124 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004124 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004124 · Verified 2026-10-09