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Sycrest

Active substance: asenapine

asenapine maleate

Centralised EU authorisationActive

Marketing holder: Organon N.V.

Verified 2026-10-09 · EMA

Analogues in other countries
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
RU 1
  • Сафрис®
    таблетки подъязычные, 10 мг (original in Russian, GRLS)
    ЛП-001526
    Н.В. Органон
US 24
  • ASENAPINE
    TABLET · ASENAPINE 10 mg/1
    42794-017
    Sigmapharm Laboratories, LLC
  • ASENAPINE
    TABLET · ASENAPINE 5 mg/1
    42794-016
    Sigmapharm Laboratories, LLC
  • Asenapine
    TABLET · ASENAPINE MALEATE 10 mg/1
    51991-361
    Breckenridge Pharmaceutical, Inc.
  • Asenapine
    TABLET · ASENAPINE 5 mg/1
    62332-198
    Alembic Pharmaceuticals Inc.
  • Asenapine
    TABLET · ASENAPINE MALEATE 2.5 mg/1
    69539-245
    MSN LABORATORIES PRIVATE LIMITED
All products in this country (24)
Import and control

Control by country

  • Russiaprescription only

    Source: GRLS (Russian state register) · record 01a120c5-076b-73b4-a005-16c52ea5b47e;count=1 · valid from 2026-10-09 · verified 2026-10-09

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-aa2e-76a9-8159-5e55ab7a34b7,01a1208d-3afe-78f9-819e-d066afad24c7,01a1208e-9c03-7889-9bf2-a8f7bfb81873,01a1208e-cc2c-71ff-b740-af5be8aed378,01a12090-1dff-7b63-a6dd-85ddcf8cefd0;count=24 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/001177
Registration status
Active
ATC code
N05AH05
Sources
  • product · EMA · EMEA/H/C/001177 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/001177 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/001177 · Verified 2026-10-09