This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide 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 Hydrochlorothiazide Zentiva.
Therapeutic Indication
### Therapeutic indication 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.
Therapeutic Area (MeSH)
N/AATC Code
C09DA04
ATC Item
irbesartan and diuretics
Pharmacotherapeutic Group
Agents acting on the renin-angiotensin system
Active Substance (Summary)
INN / Common Names
EMA Name
Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
Medicine Name
Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
Aliases
N/ANo risk management plan link.
