| EMA number | EMEA/H/C/000786 |
| ATC code | C09CA04 |
| Authorisation | 19 January 2007 |
| Withdrawn | 11 November 2009 |
| Revision | 7 |
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (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.