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Rxulti

Active substance: brexpiprazole

brexpiprazole

Centralised EU authorisationActive

Marketing holder: Otsuka Pharmaceutical Netherlands B.V.

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 1
  • Рексалти
    таблетки, покрытые пленочной оболочкой, 1 мг (original in Russian, GRLS)
    ЛП-006867
    Х. Лундбек А/О
US 16
  • Brexpiprazole
    TABLET · BREXPIPRAZOLE 3 mg/1
    27241-208
    Ajanta Pharma USA Inc.
  • Brexpiprazole
    TABLET · BREXPIPRAZOLE 2 mg/1
    27241-207
    Ajanta Pharma USA Inc.
  • Brexpiprazole
    TABLET · BREXPIPRAZOLE 4 mg/1
    27241-209
    Ajanta Pharma USA Inc.
  • Brexpiprazole
    TABLET · BREXPIPRAZOLE .25 mg/1
    27241-204
    Ajanta Pharma USA Inc.
  • Brexpiprazole
    TABLET · BREXPIPRAZOLE .5 mg/1
    27241-205
    Ajanta Pharma USA Inc.
All products in this country (16)
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c3-31bb-7074-bc0b-4ff162f99511;count=1 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-4df3-7f06-924d-1d02e3a07697,01a1208c-7f45-7a46-8b33-30bd49033020,01a1208d-50c1-7f74-8b50-711936ce3bbe,01a1208d-50c6-744a-857e-507729bfd563,01a1208e-da2e-7978-956e-262dbfe5ff2f;count=16 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/003841
Registration status
Active
ATC code
N05AX16
Sources
  • product · EMA · EMEA/H/C/003841 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/003841 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/003841 · Verified 2026-10-09