This is a summary of the European public assessment report (EPAR) for Irbesartan Zentiva. 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 Irbesartan Zentiva.
Therapeutic Indication
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.
Therapeutic Area (MeSH)
ATC Code
C09CA04
ATC Item
N/A
Pharmacotherapeutic Group
Agents acting on the renin-angiotensin system
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| irbesartan | N/A | irbesartan |
EMA Name
Irbesartan Zentiva (previously Irbesartan Winthrop)
Medicine Name
Irbesartan Zentiva (previously Irbesartan Winthrop)
Aliases
N/ANo risk management plan link.
