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Dificlir

Active substance: fidaxomicin

fidaxomicin

Centralised EU authorisationActive

Marketing holder: Tillotts Pharma 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 6
  • DIFICID
    GRANULE, FOR SUSPENSION · FIDAXOMICIN 200 mg/5mL
    52015-700
    Merck Sharp & Dohme LLC
  • Dificid
    TABLET, FILM COATED · FIDAXOMICIN 200 mg/1
    52015-080
    Merck Sharp & Dohme LLC
  • Fidaxomicin
    TABLET, FILM COATED · FIDAXOMICIN 200 mg/1
    0781-5194
    Sandoz Inc
  • Fidaxomicin
    TABLET, FILM COATED · FIDAXOMICIN 200 mg/1
    0480-2596
    Teva Pharmaceuticals, Inc.
  • Fidaxomicin
    TABLET, FILM COATED · FIDAXOMICIN 200 mg/1
    60505-4833
    Apotex Corp.
All products in this country (6)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-e6f3-77db-8aaf-cfd6ed11b1ec,01a1208d-b92d-7d5a-8c97-4c7c85201bae,01a12092-0248-76ef-a4b7-e09a01677228,01a1209c-e25e-7ec4-b714-d5b7c62a87b5,01a1209d-7c10-7dd7-b97a-31ef813751e5;count=6 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002087
Registration status
Active
ATC code
A07AA12
Sources
  • product · EMA · EMEA/H/C/002087 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002087 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002087 · Verified 2026-10-09