irbesartan / hydrochlorothiazide
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).
Karvezide : EPAR - Summary for the public (PDF/81.53 KB)
First published: 05/05/2009
Last updated: 24/09/2013
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54 rue La Boétie
15/02/2022 Karvezide - EMEA/H/C/000221 - IG1451
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Agents acting on the renin-angiotensin system
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive20/10/2011