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Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)

Active substance: irbesartan, hydrochlorothiazide

irbesartan, hydrochlorothiazide

Centralised EU authorisationActive

Marketing holder: sanofi-aventis groupe 

Verified 2026-10-09 · EMA

Analogues in other countries
Composition
Products containing irbesartan in other countries

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

CountryProducts
US 114
  • Avalide
    TABLET, FILM COATED · IRBESARTAN 150 mg/1, HYDROCHLOROTHIAZIDE 12.5 mg/1
    0024-5855
    Sanofi-Aventis U.S. LLC
  • Avalide
    TABLET, FILM COATED · IRBESARTAN 300 mg/1, HYDROCHLOROTHIAZIDE 12.5 mg/1
    0024-5856
    Sanofi-Aventis U.S. LLC
  • Avapro
    TABLET, FILM COATED · IRBESARTAN 300 mg/1
    0024-5852
    Sanofi-Aventis U.S. LLC
  • Avapro
    TABLET, FILM COATED · IRBESARTAN 150 mg/1
    0024-5851
    Sanofi-Aventis U.S. LLC
  • IRBESARTAN
    TABLET, FILM COATED · IRBESARTAN 150 mg/1
    42658-122
    Hisun Pharmaceuticals USA Inc.
All products in this country (114)
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-298a-771f-a2d3-3d47faf4fe80,01a1208c-3934-7252-b952-11ccf00c1bf4,01a1208c-5027-7329-9018-16a2d5f60e7b,01a1208c-5b37-771e-8379-96f3664329bb,01a1208c-5b39-7070-a4fd-8511e23c0d9c;count=83 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
EMEA/H/C/000783
Registration status
Active
ATC code
C09DA04
Sources
  • product · EMA · EMEA/H/C/000783 · Verified 2026-10-09
  • registration_status · EMA · EMEA/H/C/000783 · Verified 2026-10-09
  • ingredients.0 · EMA · EMEA/H/C/000783 · Verified 2026-10-09
  • ingredients.1 · EMA · EMEA/H/C/000783 · Verified 2026-10-09