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Mysimba

Active substance: bupropion hydrochloride, naltrexone hydrochloride

bupropion hydrochloride, naltrexone hydrochloride

Centralised EU authorisationActive

Marketing holder: Orexigen Therapeutics Ireland Limited

Verified 2026-10-09 · EMA

Analogues in other countries
Products containing Bupropion in other countries

Showing products with this active substance, combinations included; the full composition is shown for each product.

CountryProducts
US 350
  • AUVELITY
    TABLET, MULTILAYER, EXTENDED RELEASE · DEXTROMETHORPHAN HYDROBROMIDE 45 mg/1, BUPROPION HYDROCHLORIDE 105 mg/1
    81968-045
    Axsome Therapeutics, Inc.
  • AUVELITY
    TABLET, MULTILAYER, EXTENDED RELEASE · DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1, BUPROPION HYDROCHLORIDE 105 mg/1
    81968-030
    Axsome Therapeutics, Inc.
  • Aplenzin
    TABLET, EXTENDED RELEASE · BUPROPION HYDROBROMIDE 522 mg/1
    0187-5812
    Bausch Health US, LLC
  • Aplenzin
    TABLET, EXTENDED RELEASE · BUPROPION HYDROBROMIDE 348 mg/1
    0187-5811
    Bausch Health US, LLC
  • Aplenzin
    TABLET, EXTENDED RELEASE · BUPROPION HYDROBROMIDE 174 mg/1
    0187-5810
    Bausch Health US, LLC
All products in this country (350)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-273b-7bad-8eff-8a7560f1e9c0,01a1208c-2752-724b-8f94-0f16aa40c3a4,01a1208c-29db-7d45-b421-b9aa063fde8b,01a1208c-2cfe-72dd-9a88-34a9c272d0ab,01a1208c-328f-775e-9927-8c2eeaac0396;count=347 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/003687
Registration status
Active
ATC code
A08AA
Sources
  • product · EMA · EMEA/H/C/003687 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/003687 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/003687 · Verified 2026-10-09
  • ingredients.1 · EMA · EMEA/H/C/003687 · Verified 2026-10-09