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Xofluza

Active substance: baloxavir marboxil

Baloxavir marboxil

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
RU 2
  • Ксофлюза®
    таблетки, покрытые пленочной оболочкой, 40 мг (original in Russian, GRLS)
    ЛП-№(000927)-(РГ-RU)
    Ф.Хоффманн-Ля Рош Лтд
  • КСОФЛЮЗА®
    таблетки, покрытые пленочной оболочкой, 20 мг (original in Russian, GRLS)
    ЛП-006451
    Ф. Хоффманн-Ля Рош Лтд.
US 6
  • Xofluza
    TABLET, FILM COATED · BALOXAVIR MARBOXIL 80 mg/1
    50242-877
    Genentech, Inc.
  • Xofluza
    GRANULE, FOR SOLUTION · BALOXAVIR MARBOXIL 40 mg/20mL
    50242-583
    Genentech, Inc.
  • Xofluza
    TABLET, FILM COATED · BALOXAVIR MARBOXIL 40 mg/1
    50242-860
    Genentech, Inc.
  • Xofluza
    GRANULE, FOR SUSPENSION · BALOXAVIR MARBOXIL 30 mg/1
    50242-599
    Genentech, Inc.
  • Xofluza
    TABLET, FILM COATED · BALOXAVIR MARBOXIL 80 mg/1
    85766-058
    Sportpharm LLC
All products in this country (6)
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-3ad2-7f50-ac2c-0d9401fcba42,01a120c5-2f3c-75e6-8ae1-84c875526eff;count=2 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-6acd-7f66-a441-ebc58da182b0,01a1208f-cb47-7dc6-9808-903b2c5db14d,01a1208f-cb4a-7b32-81ed-701340d236ae,01a12091-b672-77ab-a2dd-31c0a58ab2d2,01a1209c-a39a-75e9-8975-cde58e2d0083;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/004974
Registration status
Active
Sources
  • product · EMA · EMEA/H/C/004974 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/004974 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/004974 · Verified 2026-10-09