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Tikosyn

Active substance: dofetilide

dofetilide

Centralised EU authorisationWithdrawn

Marketing holder: Pfizer Limited

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 38
  • DOFETILIDE
    CAPSULE · DOFETILIDE .25 mg/1
    47335-062
    Sun Pharmaceutical Industries, Inc.
  • DOFETILIDE
    CAPSULE · DOFETILIDE .5 mg/1
    47335-063
    Sun Pharmaceutical Industries, Inc.
  • DOFETILIDE
    CAPSULE · DOFETILIDE .125 mg/1
    47335-061
    Sun Pharmaceutical Industries, Inc.
  • DOFETILIDE
    CAPSULE · DOFETILIDE .25 mg/1
    72603-131
    NorthStar RxLLC
  • DOFETILIDE
    CAPSULE · DOFETILIDE .5 mg/1
    72603-132
    NorthStar RxLLC
All products in this country (38)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2ae7-7b08-b679-f4be0a613c49,01a1208c-3070-766d-a7ee-0684ef4e699f,01a1208c-45d1-7eb0-bfa5-8f44950f7681,01a1208c-5b79-7dc2-a56a-4574fe7a8391,01a1208c-af18-777e-81c9-e57666fed581;count=38 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000238
Registration status
Withdrawn
ATC code
C01BD04
Sources
  • product · EMA · EMEA/H/C/000238 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000238 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000238 · Verified 2026-10-09