CoAprovel

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 CoAprovel. 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 CoAprovel.

This EPAR was last updated on 16/02/2022

Authorisation details

Product details
Name
CoAprovel
Agency product number
EMEA/H/C/000222
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
45
Date of issue of marketing authorisation valid throughout the European Union
14/10/1998
Contact address

54 rue La Boetie
75008 Paris
France

Product information

15/02/2022 CoAprovel - EMEA/H/C/000222 - IG1451

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
Average
1 rating