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Emselex

Active substance: darifenacin

darifenacin hydrobromide

Centralised EU authorisationActive

Marketing holder: pharmaand 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
US 16
  • DARIFENACIN
    TABLET, EXTENDED RELEASE · DARIFENACIN HYDROBROMIDE 15 mg/1
    46708-224
    Alembic Pharmaceuticals Limited
  • DARIFENACIN
    TABLET, EXTENDED RELEASE · DARIFENACIN HYDROBROMIDE 7.5 mg/1
    46708-223
    Alembic Pharmaceuticals Limited
  • DARIFENACIN
    TABLET, EXTENDED RELEASE · DARIFENACIN HYDROBROMIDE 15 mg/1
    62332-224
    Alembic Pharmaceuticals Inc.
  • DARIFENACIN
    TABLET, EXTENDED RELEASE · DARIFENACIN HYDROBROMIDE 7.5 mg/1
    62332-223
    Alembic Pharmaceuticals Inc.
  • Darifenacin
    TABLET, EXTENDED RELEASE · DARIFENACIN HYDROBROMIDE 15 mg/1
    72162-2571
    Bryant Ranch Prepack
All products in this country (16)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-c6a4-7252-95d5-ce4ed984c017,01a1208e-c4c8-70f8-9f03-820014185c2c,01a1208f-920f-7d89-bae0-0a24331279e3,01a12094-4093-78c3-ae12-5be998716c76,01a12097-39ab-7c1e-adcc-159d81b024e3;count=16 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000554
Registration status
Active
ATC code
G04BD10
Sources
  • product · EMA · EMEA/H/C/000554 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000554 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000554 · Verified 2026-10-09