Aprovel

RSS

irbesartan

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Aprovel. 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 Aprovel.

This EPAR was last updated on 22/05/2019

Authorisation details

Product details
Name
Aprovel
Agency product number
EMEA/H/C/000141
Active substance
irbesartan
International non-proprietary name (INN) or common name
irbesartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA04
Publication details
Marketing-authorisation holder
Sanofi Clir SNC
Revision
38
Date of issue of marketing authorisation valid throughout the European Union
26/08/1997
Contact address
54, rue La Boétie
F-75008 Paris
France

Product information

11/04/2019 Aprovel - EMEA/H/C/000141 - A31/0172

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Agents acting on the renin angiotensin system

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.

Assessment history

Changes since initial authorisation of medicine

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