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 06/07/2023

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 Winthrop Industrie
Revision
46
Date of issue of marketing authorisation valid throughout the European Union
16/10/1998
Contact address

82 Avenue Raspail
94250 Gentilly
FRANCE

Product information

29/06/2023 Karvezide - EMEA/H/C/000221 - N/0215

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

Related content

How useful was this page?

Add your rating