Irbesartan

EMA (EU) Aprovel

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.

Source: European Medicines Agency (EMA), Aprovel — EPAR, 19/01/2026. © European Medicines Agency.

Document date: 19/01/2026 · Official document →

FDA (USA) IRBESARTAN

1 INDICATIONS AND USAGE 1.1 Hypertension Irbesartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Irbesartan tablets, USP may be used alone or in combination with other antihypertensive agents. 1.2 Nephropathy in Type 2 Diabetic Patients Irbesartan tablets, USP are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, irbesartan tablets, USP reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies ( 14.2 )] . Irbesartan tablets, USP are, an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) ​ Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 )

Data provided by the U.S. Food and Drug Administration.

Document date: 20260805 · Official document →

EMA (EU) Irbesartan Zentiva (previously Irbesartan Winthrop)

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.

Source: European Medicines Agency (EMA), Irbesartan Zentiva (previously Irbesartan Winthrop) — EPAR, 27/07/2026. © European Medicines Agency.

Document date: 27/07/2026 · Official document →

EMA (EU) Karvea

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.

Source: European Medicines Agency (EMA), Karvea — EPAR, 16/01/2026. © European Medicines Agency.

Document date: 16/01/2026 · Official document →