| EMA number | EMEA/H/C/000784 |
| ATC code | C09DA04 |
| Authorisation | 19 January 2007 |
| Withdrawn | 11 November 2009 |
| Revision | 8 |
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 (see section 5.1).
IRBESARTAN — CHARTWELL MOLECULAR, approved 2026-07-13 (ANDA077205).
32,041 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.