Karvezide

RSS

irbesartan / hydrochlorothiazide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Karvezide. 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 Karvezide.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 03/06/2019

Authorisation details

Product details
Name
Karvezide
Agency product number
EMEA/H/C/000221
Active substance
  • irbesartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
irbesartan / hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DA04
Publication details
Marketing-authorisation holder
Sanofi-aventis groupe
Revision
36
Date of issue of marketing authorisation valid throughout the European Union
16/10/1998
Contact address
54 rue La Boétie
75008 Paris
France

Product information

02/04/2019 Karvezide - EMEA/H/C/000221 - A31/0188

Contents

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

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