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Esbriet

Active substance: pirfenidone

Pirfenidone

Centralised EU authorisationActive

Marketing holder: H.A.C. Pharma

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 61
  • ESBRIET
    TABLET, COATED · PIRFENIDONE 801 mg/1
    83107-029
    Legacy Pharma USA Inc.
  • ESBRIET
    TABLET, COATED · PIRFENIDONE 267 mg/1
    83107-028
    Legacy Pharma USA Inc.
  • PIRFENIDONE
    TABLET, FILM COATED · PIRFENIDONE 801 mg/1
    72205-182
    Novadoz Pharmaceuticals LLC
  • PIRFENIDONE
    CAPSULE · PIRFENIDONE 267 mg/1
    50228-441
    ScieGen Pharmaceuticals, Inc.
  • PIRFENIDONE
    TABLET · PIRFENIDONE 267 mg/1
    50228-442
    ScieGen Pharmaceuticals, Inc.
All products in this country (61)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-2af5-78ca-9b1e-17fc9af10999,01a1208c-3f80-77b6-af82-56f6a5ad6e63,01a1208c-59f0-7c0e-ac0d-ebe80629a5fb,01a1208d-248c-745b-8261-e576b69453a2,01a1208d-6017-7475-bcbc-09ed1f2cfe40;count=61 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/002154
Registration status
Active
ATC code
L04AX05
Sources
  • product · EMA · EMEA/H/C/002154 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/002154 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/002154 · Verified 2026-10-09