Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)


irbesartan / hydrochlorothiazide

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide Zentiva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Irbesartan Hydrochlorothiazide Zentiva.

This EPAR was last updated on 21/11/2018

Authorisation details

Product details
Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
Agency product number
Active substance
  • irbesartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
irbesartan / hydrochlorothiazide
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
sanofi-aventis groupe 
Date of issue of marketing authorisation valid throughout the European Union
Contact address
sanofi-aventis groupe
54 rue La Boétie,
75008 Paris - France

Product information

26/07/2018 Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) - EMEA/H/C/000783 - WS/1346


Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Agents acting on the renin angiotensin system

Therapeutic indication

Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating